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- 2026-07-22 03:12:20
- Opinion
- [Reporter's View] Will Nth National Bio Innovation Committee yield any results?
- by Kim, Jin-Gu Jun 21, 2026 02:49pm
- The President Lee Jae Myung administration’s National Bio Innovation Committee hosted an inaugural consultative meeting with the leadership board of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) on June 15. This official meeting marks the first formal communication channel opened since the committee’s launch in April. With chief executives from major domestic pharmaceutical and biotech companies, the list of requests handed to the government was extensive. Long-standing industry priorities, from refining the R&D investment climate, cultivating a sustainable drug development ecosystem, to securing a stable supply of essential medicines, filled the agenda.The opening of a communication channel to reinforce public-private cooperation between the government and the pharmaceutical sector is encouraging. However, reviewing the specific agendas exchanged during this initial dialogue inevitably evokes a distinct sense of déjà vu. Previously, successive administrations have routinely established independent committees under the repeated pledge to nurture the pharmaceutical and biotech industries as a future economic growth engine. Yet, without exception, none of these bodies managed to deliver tangible results that companies could realistically feel on the ground. Compared to their highly publicized, glamorous inauguration ceremonies, their final exits during political transitions were insignificant.'The Special Committee on Biotech', established by the Park Geun-hye administration in 2016, was an organ designed to coordinate fragmented biotech-R&D roadmaps across various ministries. However, it remained functionally limited as a specialized sub-committee under the National Science and Technology Council, chaired not by a minister-level official but by the First Vice Minister of the Ministry of Science, ICT and Future Planning. Carrying a mere vice-ministerial mandate, the head of the committee found it structurally difficult to overcome regulatory barriers heavily guarded by competing ministries, such as the Ministry of Health and Welfare’s drug pricing frameworks or the Ministry of Food and Drug Safety’s marketing authorization pathways. Before taking office, the Moon Jae-in administration proposed creating a presidential-level pharmaceutical and bio-innovation committee as a core campaign pledge. Yet, following the inauguration, intense wars over institutional leadership among ministries ultimately scuttled the establishment of an independent body. As a compromise, the Special Committee on Bio-Health was created within the Presidential Committee on the Fourth Industrial Revolution. However, it primarily served as a formal communication forum. The organization was ultimately unable to overcome the inherent operational limitations of a purely advisory body devoid of statutory enforcement power or budgetary allocation authority. The Yoon Suk Yeol administration similarly voiced a strong commitment to industrial promotion, launching the Bio-Health Innovation Committee under the Prime Minister and the National Bio Committee directly under the President. Rather than concentrating state capabilities, this dual-track governance structure led to overlapping responsibilities and functional redundancies. With the centralized command center effectively fractured, administrative momentum was diluted; while sweeping macroeconomic master plans flourished, the concrete regulatory overhauls demanded by the industry stagnated. Upon taking office, the Lee Jae Myung administration immediately prioritized solving this administrative governance. To resolve the systematic inefficiencies of the preceding dual-track framework, the government dissolved and consolidated the existing committees in March, subsequently launching the unified National Bio Innovation Committee under the chairmanship of the Prime Minister in April.The National Bio Innovation Committee commenced its operations after witnessing the comprehensive 'error logs' of its pas committees, including low administrative status, deficient independence, and fragmented operational inefficiencies. Even so, the overarching slogans and macroeconomic directions advanced by the current committee remain fundamentally indistinguishable from those of past administrations. Ultimately, the differentiating factors separating success from failure are not a collection of grand blueprints, but relentless executive execution. Through the historical rise and fall of prior committees, the pharmaceutical industry has learned that even the most well-formulated strategies are rendered obsolete if they fail to transition into concrete action. The time has come to move beyond the conceptual design phase and deliver swift, impactful measures that commercial enterprises can experience on the ground. Industry attention remains focused on whether this newly formed committee will repeat the unsuccessful paths of previous political regimes to fade out as yet another impotent advisory organ, or successfully institutionalize. Having unified the administrative baseline, the National Bio Innovation Committee now enters its true proving ground. The biotech-health sector expects this specific committee to demonstrate its institutional existence by delivering concrete, definitive outcomes.
- Opinion
- [Reporter’s View] Should hair loss be covered?
- by Choi Da Eun Jun 18, 2026 03:36pm
- Discussions on extending National Health Insurance coverage to hair loss treatment have become a topic of political debate. Supporters argue that coverage is necessary to improve the quality of life for younger people, while critics question whether limited health insurance resources should be used for conditions that are not directly life-threatening.The impact of hair loss on individuals is far from trivial. Beyond the stress of physical appearance, concerns about looks have a profound impact on social interactions, interpersonal relationships, and overall mental well-being. For younger people who are particularly sensitive to appearance, hair loss may be a quality-of-life issue rather than simply a cosmetic concern.However, the National Health Insurance system is fundamentally a social safety net designed to protect life and health rather than improve the quality of life. If resources were unlimited, coverage could be expanded to include hair loss and many other conditions, but in real life, financial resources are constrained.According to the National Assembly Budget Office, the National Health Insurance system is expected to move into deficit this year, with the deficit projected to reach KRW 39 trillion by 2035. And expenditures continue to rise due to population aging and the introduction of innovative medicines. Ultimately, the insurance system must decide what to prioritize.From this perspective, the frustration felt by patients with severe and rare diseases is understandable. Cancer patients and those with rare diseases often miss optimal treatment windows due to delayed reimbursement decisions or pay hundreds to thousands of dollars out of pocket every month for non-reimbursed therapies. Many are forced to discontinue treatment because of financial burdens.Dozens of petitions calling for expanded reimbursement coverage of treatments for severe and rare diseases have been submitted over the past year through the National Assembly's petition platform and the government's Petition24 system. Patients and their families continue appeals for better access to life-saving therapies. As a result, when the government signaled that it would prioritize reviewing reimbursement coverage for hair loss treatment, criticism quickly emerged, saying, “Why is hair loss drug coverage being prioritized when review for life-saving treatments continues to be delayed due to budget constraints?”Of course, there is no reason to unconditionally oppose reimbursement for hair loss treatments. However, what we need right now is not poll results or political popularity, but a social consensus on the principles that the national health insurance must uphold.Health insurance resources are limited, and priorities must be clear. Strengthening coverage for life-saving therapies and ensuring that patients with severe and rare diseases are not forced to abandon treatment should come first. Only after those priorities are addressed should discussions move toward expanding coverage for quality-of-life improvements.This is not to suggest that hair loss is unimportant. Rather, it is a reminder to reconsider the fundamental purpose of the National Health Insurance system. The question the government must answer is not “We should support hair loss because patients suffer,” but rather “Who should be helped first with the finite amount of resources?”Once the priorities of the National Health Insurance system begin to blur, the greatest harm may ultimately fall on those patients who most urgently need reimbursement support.
- Opinion
- "Rapid symptom relief"…'Rhapsido' a new treatment option for CSU
- by Son, Hyung Min Jun 18, 2026 03:35pm
- "Chronic spontaneous urticaria (CSU) is not simply a dermatological condition. A significant number of patients remains inadequately controlled with existing treatments. There is a significant medical need for novel therapeutic options." During a recent joint interview with DailyPharm, Dr. Sarbjit Saini, a professor of the Division of Allergy & Clinical Immunology at Johns Hopkins University School of Medicine, and Dr. Jeong-Hee Choi, a professor of the Department of Pulmonology and Allergy at Hallym University Dongtan Sacred Heart Hospital evaluated the unmet medical needs in CSU and the strategic significance of emerging treatments. The therapeutic landscape for CSU is undergoing a new shift. Patients remain highly symptomatic despite standard antihistamine treatments. Therefore, attention is drawn to domestic approval of Novartis’s Rhapsido (remibrutinib), the first oral Bruton’s tyrosine kinase (BTK) inhibitor indicated for this patient population. This drug has been demonstrated to provide rapid symptom relief.CSU is a chronic inflammatory skin disease characterized by recurrent wheals and angioedema persisting for six weeks or longer without specific triggers. Although urticaria is commonly dismissed as a transient allergic reaction, CSU is differentiated from typical acute urticaria by its long-term recurrence and highly unpredictable patterns of exacerbation and remission.The overall disease burden carried by patients is substantial. Recurrent pruritus and wheals frequently lead to sleep disorders and fatigue, and when accompanied by facial or lip edema, significantly compromise interpersonal relationships and social activities. The persistent anxiety surrounding sudden symptom exacerbation serves to restrict patients' daily routines. In real-world clinical practice, patients routinely complain of itching, sleep deprivation, impaired concentration, and diminished work efficiency; however, the disease itself still tends to be misperceived as a basic skin condition.Dr. Sarbjit Saini, a professor of the Division of Allergy & Clinical Immunology at Johns Hopkins University School of Medicine, and Dr. Jeong-Hee Choi, a professor of the Department of Pulmonology and Allergy at Hallym University Dongtan Sacred Heart Hospital Current CSU management utilizing standard second-generation antihistamines serves as the first-line therapy, with additional interventions, such as dose escalation or the introduction of biologic agents, considered if symptom control remains insufficient. Nevertheless, more than half of the patient is reported to experience inadequate symptom control despite undergoing antihistamine therapy.For patients who continue to present with pruritus and wheals following antihistamine dose escalation, available therapeutic options are highly restricted. Although clinical guidelines recommend a staged escalation of treatment, real-world execution is frequently hindered by a combination of low disease awareness, limited treatment access, financial constraints, and the logistical burden of frequent hospital visits.Certain patients rely on short-term pharmacological interventions during acute flares or repeatedly cycle through treatments with heavy long-term burdens, such as systemic corticosteroids. However, medical experts point out that because CSU requires chronic management, a purely reactive approach focused on mitigating acute exacerbations is insufficient to adequately alleviate the cumulative disease burden.Under these circumstances, Rhapsido is being evaluated as an option capable of introducing new dynamics to the established treatment paradigm. As the inaugural oral BTK inhibitor indicated for CSU, Rhapsido selectively inhibits BTK, an enzyme involved in the upstream activation pathways of mast cells and basophils, a mechanism designed to directly block the secretion of histamine and secondary co-inflammatory mediators.While conventional antihistamines operate by blocking already secreted histamine from binding to its receptors, Rhapsido works by modulating the upstream signaling pathways of the histamine release cascade. This targeted therapeutic approach is drawing considerable interest, particularly for addressing the complex autoallergic and autoimmune pathways concurrently involved in CSU.Dosing convenience represents another key differentiator. Administered as a twice-daily oral medication, Rhapsido offers a novel alternative for patients who feel burdened by injectable therapies like 'Xolair (omalizumab)' or face difficulties accommodating regular hospital visits. Given that the CSU patients features a high proportion of young, socially active individuals, the arrival of an oral targeted option carries substantial clinical weight.In clinical trials, Rhapsido demonstrated rapid improvement of symptoms. In the REMIX-1 and REMIX-2 studies, Rhapsido demonstrated measurable improvements in pruritus and wheals starting from week 1 of administration, and significantly improved the weekly Urticaria Activity Score (UAS7) compared to placebo at week 12. In certain patients, a complete resolution of both itching and hives was documented alongside overall disease control.Recently updated international urticaria guidelines establish complete symptom control as the ultimate therapeutic objective, integrating Rhapsido as a validated targeted option to be considered following antihistamine therapy. This global regulatory momentum is anticipated to influence domestic clinical guidelines during future revision processes.However, industry specialists note that maximizing real-world clinical utility will require the accumulation of additional prescriptive experience and the securing of treatment access. As a therapeutic agent featuring a novel mechanism of action, the process of collecting localized user experiences and long-term safety data within domestic cohorts remains vital, with pricing pressures and reimbursement status serving as core variables dictating patient access.Both experts assessed that "Rhapsido is an orally accessible, novel targeted therapeutic option that offers a meaningful alternative for patients who remain uncontrolled on conventional regimens," and added, "As real-world treatment experience and clinical evidence accumulate, we anticipate significant realignments in established CSU management strategies."Q. What specific clinical and daily challenges have been experienced by CSU patients whose symptoms were difficult to control using existing treatments alone?Dr. Sarbjit Saini, a professor of the Division of Allergy & Clinical Immunology at Johns Hopkins University School of Medicine[Dr. Saini] The single greatest challenge is that symptom onset and acute flares manifest in a highly unpredictable manner.Even when baseline disease activity has decreased, a sudden, severe exacerbation of angioedema causing facial and lip swelling can induce immense panic in patients, driving an immediate demand for medical intervention. Ultimately, this creates deep anxiety that stems from the perception of being unable to self-manage the disease.Although antihistamines are used to regulate the symptoms and overall severity of CSU patients, the practical therapeutic efficacy that could be expected has faced clear limitations.For individuals experiencing persistent, inadequate symptom control, clinicians have ultimately had to rely on interventions like systemic corticosteroids. However, while corticosteroids deliver rapid short-term efficacy, their well-documented adverse event profile makes them a highly unfavorable maintenance option. Consequently, prior to the recent emergence of these novel therapies, the available treatment choices were exceptionally limited.[Dr. Choi] Non-responsiveness to high-dose antihistamines has been reported in as few as 20% to as many as 50% of patients, while approximately 20% remain refractory to Xolair. In the past, various immunomodulators, including antimalarials, were attempted, and the subsequent introduction of the biologic agent Xolair established a safer and more effective therapeutic alternative. However, Xolair still carries the logistical burden of requiring patients to visit the clinic once a month for injections.Above all, the intense pruritus associated with CSU is an exceptionally difficult symptom for patients to tolerate. When symptoms worsen, patients demand therapeutic options that offer superior convenience and rapid responsiveness. While currently developing therapeutics target complete disease control, whether these agents can fundamentally alter the long-term course of the disease requires further observation. Rhapsido carries significant potential and high expectations as a treatment option featuring a novel mechanism of action.Q. What is the mechanistic significance of BTK inhibitors within the therapeutic management of CSU?[Dr. Choi] The pathophysiology of urticaria is fundamentally understood to be driven by immunoglobulin E (IgE) cross-linking and mast cell activation. While Xolair directly inhibits circulating IgE molecules, BTK inhibitors differentiate themselves by blocking the downstream intracellular signaling cascades required for mast cell activation following that receptor binding event.The pathophysiology of urticaria is fundamentally understood to be driven by immunoglobulin E (IgE) cross-linking and mast cell activation. While Xolair directly inhibits circulating IgE molecules, BTK inhibitors differentiate themselves by blocking the downstream intracellular signaling cascades required for mast cell activation following that receptor binding event.[Dr. Saini] The BTK inhibitor Rhapsido acts directly upon mast cells and basophils, which secrete symptom-inducing inflammatory compounds like histamine, thereby directly suppressing the actual exocytosis of the inflammatory mediators responsible for triggering pruritus, swelling, and angioedema. It also modulates B-cells, which are immune cells responsible for antibody production, a pathway believed to potentially exert an effect on the underlying autoantibody responses driving CSU symptom expression.Q. How do you evaluate the efficacy and safety data confirmed for Rhapsido in clinical studies? Which data are significant?[Dr. Saini] From an efficacy standpoint, Rhapsido demonstrated a comparatively rapid onset of symptom relief. The Rhapsido-treated cohorts exhibited measurable symptom separation from the placebo arm at an early juncture, with tangible symptom improvements manifesting as early as week 1 of administration. This Phase III program enrolled severe patients whose disease was inadequately controlled on antihistamines, many of whom had carried a heavy disease burden for extended durations, with a mean disease duration of approximately six years. Furthermore, about one-third of the participants were patients who remained uncontrolled despite extensive prior experience with existing advanced therapies.The initial 24 weeks of the study followed a double-blind, placebo-controlled design, after which the placebo-assigned patients crossed over to active Rhapsido therapy. Upon switching, these crossover patients likewise demonstrated rapid disease control. Moreover, the 52-week long-term analysis confirmed that this therapeutic efficacy was stably and durably maintained over extended administration.Regarding safety, the oncology sector has already established a baseline level of experience with early-generation BTK inhibitors, and subsequent generations have continually optimized molecular selectivity. Rhapsido similarly demonstrated clinical efficacy without triggering pronounced or elevated signals for the adverse events historically associated with older BTK inhibitors.Dr. Jeong-Hee Choi, a professor of the Department of Pulmonology and Allergy at Hallym University Dongtan Sacred Heart Hospital [Dr. Choi] In my opinion, the clinical trial results for Rhapsido is highly positive. Initially, there were baseline concerns within the medical community that the mechanism of BTK inhibition might induce overly broad systemic suppression of immune responses. However, Rhapsido's highly selective mechanism has been consistently demonstrated, and the actual clinical datasets continue to show highly stable outcomes.In the clinical perspective, attention is drawn to the speed of symptom improvement. Xolair often shows varying response times across distinct patient subsets, and parameters such as baseline IgE levels are sometimes used to predict treatment responsiveness. In contrast, Rhapsido's capacity to induce rapid improvements in pruritus and urticarial lesions independent of these biological variables was highly impressive.The current lack of extensive comparative trials against Xolair limits direct cross-trial conclusions. Nonetheless, evaluating the data package compiled to date suggests that this oral small molecule can deliver efficacy comparable to that of established standard-of-care biologic agents.Q. Given Rhapsido's rapid symptom improvement, which specific patient subpopulations do you anticipate will benefit most in real-world clinical practice?[Dr. Choi] The primary candidates will be patients who require advanced step-up interventions due to inadequate disease control on optimized antihistamine regimens. Additionally, the option can be strategically considered during the treatment selection process for patients who cannot tolerate continuous high-dose antihistamines due to side effects, individuals facing logistical hurdles that restrict regular clinic visits for injections, and patients harboring a strong aversion or resistance to injectable therapies.[Dr. Saini] Priority consideration can be given to patients maintaining high baseline disease activity despite cycling through multiple antihistamines and various advanced therapies mandated by prior tiers of established clinical guidelines.It can also deliver distinct benefits in clinical scenarios requiring rapid stabilization, such as patients with severe edema or angioedema who frequently present to emergency departments. Furthermore, it represents a viable alternative for individuals currently dependent on oral corticosteroids due to a lack of alternative options, patients experiencing dose-limiting toxicities such as somnolence from legacy antihistamine choices, and individuals undergoing immunosuppressive therapies like cyclosporine that necessitate rigorous, ongoing laboratory safety monitoring.Q. Despite its recent regulatory clearance, Rhapsido was swiftly integrated into international guidelines. How do you evaluate this rapid academic adoption?[Dr. Saini] The relatively rapid inclusion of Rhapsido into global guidelines indicates that international medical societies, steering committees, and researchers concluded that the product's clinical value had been robustly validated through its clinical data package.To date, approximately six to seven months of commercial real-world user experience has been compiled in the United States, alongside a broader experience across diverse patient cohorts via clinical trial extensions. Our perspective on this real-world clinical feedback is highly positive.The rapid onset of symptom relief documented in controlled trials is being directly mirrored in clinical practice, with clinicians frequently recording instances where patients explicitly report rapid, tangible improvements. For patients, directly experiencing this rapid therapeutic validation serves as a powerful driver that reinforces long-term treatment adherence and persistence.[Dr. Choi] Its prompt integration as a primary scond-line therapy within international consensus guidelines carries significant weight. While the domestic medical community will naturally look to expand its localized clinical experience, this international endorsement provides a solid foundation of clinical confidence for South Korean prescribers.Because Korean experts had already established expectations and early familiarity through participation in global clinical programs, the broader medical community is viewing this rapid guideline integration with substantial optimism.Q. How do you project the long-term evolution of the CSU commercial and clinical landscape moving forward?[Dr. Choi] When Xolair initially entered the marketplace, there was a baseline level of clinical hesitation toward adopting a novel mechanism, which gradually dissolved as extensive real-world safety registries expanded. Today, it stands as a trusted, routine intervention, and I anticipate Rhapsido will chart a highly identical trajectory of market assimilation.There is currently strong consensus within the medical community on the need to update South Korea's localized CSU clinical consensus guidelines. The revision process is slated to commence late this year with completion targeted for next year, during which Rhapsido's positioning will be evaluated in depth.From a policy and structural standpoint, bolstering market access and affordability remains imperative, as refractory chronic urticaria continues to receive insufficient public health attention relative to its severe daily disease burden. Nevertheless, the ongoing diversification of the advanced therapeutic arsenal marks a clearly meaningful shift for patient care.In the future, we must collaborate to establish an ecosystem that supports sustained, optimized treatment pathways, necessitating synchronized public health advocacy and pricing policy discussions.[Dr. Saini] I anticipate robust, expansive prescription adoption of Rhapsido globally. The product addresses a critical commercial white space by offering patient-centric dosing convenience while drastically shortening the time-to-resolution, fundamentally elevating the standard of care for patients suffering from refractory CSU.Beyond urticaria, the asset possesses significant pipeline expansion potential across broader allergic indications. Early-stage data packages in food allergy have already demonstrated promising outcomes, where the molecule rapidly attenuated hypersensitivity reactions in peanut- and tree-nut-sensitive cohorts, signaling its utility in mitigating anaphylactic risks during accidental allergen exposures.The mechanism could similarly be utilized within the drug allergy sector. In clinical scenarios where a patient presents with a known allergy to an indispensable, non-substitutable therapeutic agent, co-administration of a highly selective BTK inhibitor could, in theory, provide a vital protective buffer, opening new avenues for safe desensitization protocols.
- Opinion
- ‘Biologics have transformed Korea’s asthma treatment landscape’
- by Son, Hyung Min Jun 09, 2026 10:00am
- The treatment landscape for severe asthma is changing rapidly. In the past, patients whose symptoms remained uncontrolled despite treatment with high-dose inhaled corticosteroids (ICS) and long-acting beta agonists (LABA) had few treatment options beyond oral corticosteroids (OCS).Patients who experienced repeated exacerbations, emergency room visits, and hospitalizations often had no choice but to depend on long-term steroid treatment. In the process, they were exposed to the risk of numerous complications, including osteoporosis, obesity, diabetes, and cataracts.However, the emergence of biologics targeting the inflammatory mechanisms underlying the disease has fundamentally changed the treatment paradigm. In particular, for Type 2 inflammatory severe asthma, which is characterized by eosinophilia and allergic responses, personalized treatment based on biomarkers and patient phenotypes has become possible, expanding treatment goals beyond simple symptom control to prevention of exacerbations, reduction of systemic steroid use, and even clinical remission.Dailypharm spoke with Professor Guy Brusselle of the Department of Respiratory Medicine at Ghent University Hospital in Belgium and Professor Yoo-sook Cho of the Department of Allergy and Clinical Immunology at Asan Medical Center to discuss changes in the global severe asthma treatment landscape, the clinical significance of biologics, and the challenges facing Korea’s treatment environment.Professor Guy Brusselle, Department of Respiratory Medicine, Ghent University Hospital, Belgium; Professor Yoo-sook Cho, Department of Allergy and Clinical Immunology, Asan Medical CenterThe Global Initiative for Asthma (GINA) recommends biologic therapy guided by Type 2 inflammatory biomarkers in patients with severe asthma that remains uncontrolled despite high-dose ICS-LABA treatment. Recent updates to the guidelines also place greater emphasis on early intervention and proactive disease control rather than responding only after exacerbations occur. In other words, treatment goals are shifting from “managing uncontrolled asthma” to “achieving remission.”Most asthma patients can control their symptoms with ICS, LABAs, and relievers. Severe asthma patients, however, continue to experience symptoms and repeated exacerbations despite optimized treatment using high-dose ICS and LABAs.In fact, biologics are being used more broadly and rapidly in real-world clinical practice globally. Using objective indicators such as blood eosinophil counts and fractional exhaled nitric oxide (FeNO) to classify patient characteristics and applying targeted therapies has become the standard among physicians. In some countries, switching between biologics based on treatment response is also widely practiced.Korea presents a somewhat different picture. Reimbursement criteria for biologics remain strict, and patients still face substantial out-of-pocket costs. Even when patients fail to respond adequately to a specific biologic, they often must meet reimbursement requirements all over again before switching to another treatment. This is why criticism continues to rise on how difficult it is to implement treatment strategies tailored to individual patient needs in practice.According to the International Severe Asthma Registry (ISAR), the global average biologic utilization rate is 25.4%, whereas Korea’s rate is only 1.4%. Experts view this gap as reflecting differences not merely in prescribing patterns but also in healthcare systems and reimbursement policies.Recently, there have been growing calls for severe asthma patients to be managed as a distinct disease population and for increased treatment access for the patient group. In other words, asthma requires support that reflects the disease burden and quality of life impact in a manner similar to cancer and rheumatic diseases.Both professors emphasized that as treatment goals in severe asthma evolve from symptom control toward remission, treatment environments should also evolve to accommodate such change.Q. What has been the most significant change in the severe asthma treatment landscape in recent years?Professor Yoo-sook Cho, Department of Allergy and Clinical Immunology, Asan Medical CenterProfessor Cho: The emergence of biologics itself represents the most significant change. Unlike how treatment options were limited in the past, patients with severe asthma who could not be adequately controlled with conventional inhaler therapies now have access to entirely new treatment options.Particularly with the addition of new biologics to the severe asthma section of the GINA guidelines, we are witnessing more than a guideline update—the treatment paradigm itself is changing.Professor Brusselle: Severe asthma is not simply asthma with severe symptoms. It refers to patients whose disease remains uncontrolled despite receiving appropriate treatment over a sufficient period of time. Approximately 5% of adult asthma patients fall into this category.Today, physicians can evaluate blood eosinophil levels and FeNO to determine whether Type 2 inflammation is present and then select an appropriate biologic. Compared with the past, this represents a tremendous advancement.Q. How has the severe asthma treatment environment changed with the introduction of biologics?Professor Brusselle: Before biologics were available, long-term systemic corticosteroid therapy was often the only next-step treatment option. However, oral corticosteroids can cause numerous complications, including obesity, osteoporosis, and cataracts, and long-term use may lead to irreversible damage.Biologics, on the other hand, help reduce steroid-related toxicity while providing safer disease control. Major biologics include ‘Fasenra (benralizumab),’ ‘Nucala (mepolizumab),’ and ‘Dupixent (dupilumab),’ all of which have demonstrated favorable efficacy and safety profiles.Professor Cho: In practice, there are patients whose asthma continues to worsen despite diligent inhaler use and aggressive treatment of comorbidities. These patients often become dependent on steroids.Biologics can reduce or even eliminate steroid use while also decreasing the frequency of exacerbations. That is why they can truly be described as game changers in severe asthma treatment.Q. How is the global treatment landscape evolving?Professor Guy Brusselle, Department of Respiratory Medicine, Ghent University Hospital, BelgiumProfessor Brusselle: The GINA guidelines have been continuously updated since 1993 and have evolved based on evidence from randomized clinical trials as well as real-world clinical data. One of the greatest strengths of these guidelines is that they address healthcare environments in both high-income and low-income countries, while also taking a multidisciplinary approach that extends beyond pulmonology to primary care settings.In the past, rheumatic diseases were often treated only after joint damage had already occurred. Today, however, treatment is initiated aggressively before irreversible damage develops.The same principle applies to severe asthma. Patients should be treated proactively before airway remodeling or lung function declines occur. In fact, a substantial proportion of patients receiving biologic therapy achieve clinical remission.Patients no longer talk about what asthma prevents them from doing. Instead, they talk about what they are able to do despite having asthma. Improving quality of life is also an important therapeutic goal.Q. What is the greatest limitation in Korea’s treatment environment?Professor Cho: The biggest issue is accessibility. Currently, only an estimated 10–20% of patients who meet indications for biologic therapy are actually receiving biologics in Korea.Even after reimbursement approval, patients often face monthly out-of-pocket expenses of approximately KRW 800,000–900,000. In addition, even when a patient fails to respond adequately to a particular biologic, reimbursement criteria must often be met again before switching to another therapy.As a result, cases occur where patients must wait for their condition to worsen to try a new treatment.Q. How do Korea’s reimbursement criteria and restrictions on switching between biologics affect clinical practice?Professor Cho: Restrictions on switching are currently considered one of the biggest challenges in Korea. Even if a patient does not respond sufficiently to a particular biologic, they must satisfy reimbursement requirements again before switching to another option. As a result, physicians sometimes find themselves waiting for a patient's condition to deteriorate before they can initiate a new treatment strategy.Initial treatment selection is also important. In Korea, differences in launch timing and pricing often result in the prior use of lower-cost biologics. However, in real-world practice, physicians frequently consider switching to Fasenra when patients fail to achieve adequate responses with Nucala or Cinqair (reslizumab).Professor Brusselle: In Belgium, switching between biologics is permitted. However, the most important factor is accurately identifying the patient’s phenotype and selecting the most appropriate drug. In this sense, collaboration with otolaryngologists is also extremely important. In patients with chronic rhinosinusitis accompanied by nasal polyps, upper airway disease status should also be taken into account when selecting a biologic.Q. What are your thoughts on special reimbursement calculation programs and measures to reduce patient burden being carried out in Korea?Professor Brusselle: In Belgium, patients with severe asthma benefit from low out-of-pocket cost structures similar to those available for patients with rheumatic diseases and cancer. By contrast, I was surprised that in Korea, patients with rheumatic diseases or atopic dermatitis often face co-insurance rates of around 5%, whereas patients with severe asthma do not receive any comparable support.Professor Cho: In Korea, asthma is relatively common, and symptoms differ broadly due to disease characteristics, which may explain why policymakers have adopted a more conservative approach.Recently, however, efforts have been made to classify patients with severe asthma under a separate disease code (Severe eosinophilic asthma, J82.12) and to manage them as a distinct patient population. This initiative is intended to more accurately identify the number of patients who genuinely require biologic therapy. Ultimately, the key issue is ensuring appropriate treatment access for patients who truly need these therapies.Q. What improvements are needed in the future severe asthma treatment environment?Professor Brusselle: Ideally, patients with severe asthma should face co-insurance rates below 5%, similar to patients with cancer or rheumatic diseases. Also, patient advocacy groups should have a stronger voice in healthcare policy decision-making processes.Professor Cho: Realistically, it may not be possible to provide unrestricted access to every biologic drug. However, patients with severe asthma should be guaranteed treatment opportunities comparable to those available for other severe immune-mediated diseases at the very least.The reality is that access to biologics for severe asthma patients remains lower than both the global standards and levels seen in other immune-related diseases within Korea. So priority should therefore be given to expanding special reimbursement programs and allowing switching between biologics.Pharmacoeconomic evaluations should also consider not only drug acquisition costs but also quality-of-life impairment, limitations on social activities, and the long-term costs associated with steroid toxicity.
- Opinion
- [Reporter’s View] To whom should drug prices be disclosed
- by Jung, Heung-Jun May 27, 2026 04:10pm
- As Korea’s ‘flexible drug pricing contract system,’ which applies dual pricing to pharmaceuticals, goes into full implementation next month, further discussion is needed regarding the scope of disclosure for actual drug prices.Until now, actual drug prices were publicly disclosed through pricing files or reimbursement lists and maximum reimbursement price tables. Going forward, however, information, including products subject to flexible pricing contracts, will only be provided to ‘authorized users,’ such as healthcare institutions.And even authorized users are being cautioned not to use the information for purposes other than calculating pharmaceutical expenses or disclosing it externally.Starting this June, the actual prices of the 12 items listed will not be provided to the general public, who are considered “unauthorized parties.” While there is a difference of 2 to 5 times or more between the listed prices and actual prices of these 12 items, the public reimbursement list only reveals the listed price and whether a flexible pricing contract applies.Considering the purpose of the system, setting outwardly visible prices high in order to maintain competitiveness in international reference pricing systems, such measures may appear understandable.However, as time passes and the number of contracted items increases to the hundreds, information asymmetry is bound to grow. The wider this gap becomes, the more drug price transparency will steadily erode.The government introduced dual pricing primarily to avoid damaging international reference prices when multinational pharmaceutical companies supply medicines to the Korean market or when domestic companies export products overseas.It is difficult to deny that expanding flexible pricing contracts is unavoidable in order to improve access to innovative drugs. It is also clear that the system could strengthen export competitiveness for Korean-developed drugs.However, if preventing damage to reference pricing is truly the main objective of the system, there is no reason to withhold actual pricing information from citizens who wish to know it.Since the dual pricing system differs from risk-sharing agreements in terms of its purpose and contractual methods, is there really a need to keep the actual prices under the flexible pricing system tightly under wraps? If patients, caregivers, researchers, or others are curious about the actual price of a specific drug subject to dual pricing, there should be a way to provide that information.Until now, the general public had no way to access drug prices other than through the reimbursement list. Now that the dual drug pricing system has been implemented, additional methods of access must be provided.Even a passive form of disclosure, such as providing actual pricing information when separately requested by patients or caregivers, should be considered.To prevent the growing information asymmetry from leading to public distrust of drug pricing, the authorities must engage in open deliberation and develop supplementary measures.
- Opinion
- Bayer accelerates expansion of new drug portfolio
- by Son, Hyung Min May 27, 2026 04:09pm
- Bayer expressed confidence in its growth prospects, highlighting its new drug portfolio –which focuses on cardiovascular and renal disease, oncology, and ophthalmology -- along with next-generation pipelines based on cell and gene therapies.Despite growing pressure from patent expirations and biosimilar competition, the company believes it has established new growth drivers beyond its traditional reliance on blockbuster products. In particular, Bayer identified Korea as a strategic market where the value of innovative therapies can be realized rapidly, while also signaling plans to expand clinical collaborations and startup partnerships.Sebastian Guth, Chief Operating Officer of Bayer PharmaceuticalsSebastian Guth, Chief Operating Officer of Bayer Pharmaceuticals, recently told reporters, “Bayer is entering a new phase of growth based on its strongest-ever portfolio and innovative pipeline. We are focusing on providing first-in-class or best-in-class treatment options in areas with high unmet medical needs.”The global pharmaceutical industry is currently facing a triple burden of patent cliffs, drug pricing pressure, and rising drug development costs, intensifying competition to secure next-generation growth engines. Bayer is no exception, facing the patent expiration of Xarelto (rivaroxaban) and biosimilar competition against Eylea (aflibercept) 2mg.However, Bayer expressed confidence that it can sustain growth momentum through new drug competitiveness in cardiovascular-renal disease, oncology, and ophthalmology, along with future pipelines based on precision medicine and cell and gene therapy.In fact, Bayer secured a total of 5 regulatory achievements last year, including 3 new drug approvals and 2 expanded indications, while also generating positive results from 6 late-stage global clinical trials. Based on this, the company has set goals of restoring growth after 2027 and achieving a 30% operating margin by 2030. According to Guth, Bayer is strategically concentrating on oncology, cardiovascular-renal disease, neurology, rare diseases, and immunology as core therapeutic areas.Kerendia, Nubeqa, and Eylea emerges as growth drivers…“Portfolio transition accelerates”Bayer’s confidence stems from the emergence of new growth products. The company believes Kerendia (finerenone) and Nubeqa (darolutamide) are driving tangible sales growth, while high-dose Eylea (8mg) is establishing itself as a new treatment option in ophthalmology and filling the gap left by existing blockbuster products.Kerendia, in particular, is emerging as a key pillar in Bayer’s integrated cardiovascular-renal treatment strategy. After being approved in Korea for chronic kidney disease associated with type 2 diabetes, Kerendia recently secured an additional indication for heart failure with a left ventricular ejection fraction of 40% or greater. While traditional heart failure treatment has mainly focused on reduced ejection fraction heart failure, treatment options for preserved ejection fraction heart failure have remained relatively limited, and Bayer sees strong potential for changing treatment paradigms in this area.Guth said, “Heart failure with preserved ejection fraction is an area with high unmet medical need in Korea as well. We are focusing on how Kerendia can benefit patients in actual clinical practice.”The prostate cancer treatment Nubeqa is also a core growth driver within Bayer’s oncology portfolio. Nubeqa has expanded its indications in Korea from high-risk non-metastatic castration-resistant prostate cancer to metastatic hormone-sensitive prostate cancer, broadening its treatment scope. Recently, reimbursement criteria for metastatic hormone-sensitive prostate cancer were also established, increasing expectations for improved patient access. Bayer aims to strengthen its leadership in prostate cancer treatment through Nubeqa while also creating future synergies with radiopharmaceutical-based therapies.In ophthalmology, Eylea 8mg was highlighted as a next-generation growth driver. With the aging population and the rise in chronic diseases leading to an increase in patients with age-related macular degeneration and diabetic macular edema, the drug is considered significant because it has the potential to extend treatment intervals, thereby reducing both the financial burden on patients and the workload on healthcare providers. Bayer holds commercial rights for Eylea outside the United States, and the drug is continuing to grow in multiple countries, including Korea.Guth said, “Nubeqa and Kerendia recorded combined growth of 68% last year and exceeded market expectations. Even amid difficult conditions such as the competition brought on by the introduction of Xarelto generics and Eylea 2mg biosimilars, the growth potential of our core products is translating into tangible results.”Accelerating development of cell and gene therapies…”Targeting root causes beyond symptom relief”Bayer positioned cell and gene therapies and precision medicine at the forefront of its future growth strategy. The key concept is “disease modification,” which seeks not merely to manage symptoms but to alter disease progression itself.Parkinson’s disease was presented as a representative example. Bayer is simultaneously developing both cell therapy and gene therapy approaches for Parkinson’s disease.The cell therapy ‘bemdaneprocel’ is a one-time treatment designed to replace lost dopamine-producing neurons and is currently in late-stage clinical development. Meanwhile, the gene therapy ‘AB-1005(ametefgene parvec)’ is being developed to restore neurological function and slow disease progression. Guth explained that these represent entirely new approaches in the field of Parkinson’s disease, where fundamental therapeutic progress has been limited for decades.Guth said, “Parkinson’s disease is an area where there has been little significant therapeutic progress for decades, and Bayer is making meaningful breakthroughs. Because Parkinson’s disease has a severe impact not only on patients but also on their families, we hope both therapies can be developed successfully.”As a next-generation cardiovascular pipeline, Guth highlighted Bayer’s factor XI inhibitor asundexian.Although asundexian faced a temporary development setback for the atrial fibrillation indication, the drug regained momentum by securing positive results in late-stage clinical trials for secondary stroke prevention after strategic adjustments. Bayer expects this drug to set a new standard of care in the future.Guth said, “We experienced setbacks where the research did not meet expectations, but after reviewing the scientific evidence again, we regained confidence in the direction. It is important to learn and stay focused even in the face of failure.”Guth also identified ‘225Ac-PSMA Trillium,’ currently being developed for metastatic castration-resistant prostate cancer, as one of Bayer’s major pipelines.225Ac-PSMA Trillium is a targeted alpha radioligand therapy directed at prostate-specific membrane antigen (PSMA). Bayer plans to expand its prostate cancer treatment strategy by adding next-generation radiopharmaceuticals to the prostate cancer portfolio already built around Nubeqa.“Prostate cancer is an area with high global prevalence and significant unmet medical need. We expect this therapy to bring meaningful changes to patient treatment.”“Korea is a strategic market”…expanding clinical collaboration and startup partnershipsOne of the messages repeatedly emphasized during the interview was the strategic importance of the Korean market. Bayer views Korea not merely as a sales market, but as a global innovation hub with strong scientific capabilities and rapid adoption of innovation.In fact, as of 2025, Korea was found to conduct the second-largest number of investigator-initiated research (IIR) studies worldwide, following the United States.Guth remarked, “Korea’s scientific capabilities are beyond doubt, and the country also possesses outstanding R&D capabilities. There are active efforts aimed not merely at improving existing treatments but at developing first-in-class or best-in-class treatments.”Starting this year, Bayer officially launched “Bayer Co.Lab Connect Seoul,” a collaboration program targeting domestic biotech startups.This program is the Korean version of Bayer’s global life science incubator model previously operated in major innovation hubs worldwide. Rather than simply providing financial support, the program focuses on offering global expertise in regulatory strategy, commercialization, market access, and pricing.“Innovation cannot be achieved alone; Collaboration among academia, startups, and companies is important. Our collaboration with Korea has now moved beyond discussion and entered the execution stage.”At the same time, Bayer plans to use artificial intelligence as a key R&D driver to improve productivity across drug development, clinical research, and pharmacovigilance. The company aims to increase R&D productivity and shorten the time required for innovative therapies to reach patients by 2030 through AI-based technologies.“The advancement of AI-based technologies is fundamentally changing the paradigm of drug development, and research capabilities that seemed impossible only a few years ago are now becoming a reality. Bayer will actively leverage this technological turning point to accelerate R&D innovation and ensure that we achieve our stated goals.”
- Opinion
- "The expected probability of a clinical cure for TNBC"…Keytruda
- by Son, Hyung Min May 22, 2026 10:25am
- Although triple-negative breast cancer (TNBC) accounts for approximately 15 to 20% of all breast cancer cases, it is recognized as a highly aggressive subtype with a significant risk of recurrence.Due to the lack of hormone receptors (HR) or HER2 expression, targeted therapies cannot be used, leaving patients with relatively limited treatment options. It has been classified as a high-risk breast cancer, particularly due to the high risk of recurrence and mortality within five years of diagnosis.TNBC carries a high risk of recurrence even in relatively early stages (Stages I and II), and recurrence is highly likely to manifest as distant metastasis. Notably, the T2N0 patient population, characterized by a tumor size of 2 to 5 cm and node-negative status, has recently regarded as a high-risk subgroup requiring aggressive therapeutic intervention.Amid this therapeutic landscape, analysis suggests that a perioperative treatment strategy based on the cancer immunotherapy 'Keytruda (pembrolizumab)' is leading a paradigm shift in the management of early-stage TNBC.Professor Hee Kyung Ahn, Department of Hematology-Oncology, Samsung Medical CenterKeytruda received regulatory approval from the Ministry of Food and Drug Safety (MFDS) in July 2022 for the perioperative treatment of high-risk early-stage TNBC.Based on the KEYNOTE-522 clinical study, Keytruda demonstrated significant improvements not only in pathological complete response (pCR) but also in event-free survival (EFS) and overall survival (OS). Consequently, it is drawing attention as a therapeutic strategy aimed at increasing the probability of a clinical cure rather than merely delaying disease recurrence.As a result, an integrated therapeutic approach encompassing neoadjuvant chemotherapy, definitive surgery, and subsequent adjuvant therapy is increasingly well established in real-world clinical practice.DailyPharm met with Professor Hee Kyung Ahn of the Department of Hematology-Oncology at Samsung Medical Center to discuss the shifting treatment paradigms in early-stage TNBC and the clinical implications of Keytruda-based perioperative therapy.Q. What are the changes in clinical practices since Keytruda was approved for early-stage TNBC?The therapeutic landscape has transformed significantly over the past few years, and Keytruda is now widely used in clinical settings.Today, we no longer proceed to surgery first, even for node-negative Stage IIA patients. Instead, neoadjuvant therapy with Keytruda is used, followed by a risk-based adjuvant regimen regardless of whether the patient achieves pCR post-surgery. Because robust clinical trial data have demonstrated survival benefits with this strategy, proactive clinical interest and adoption have risen substantially.Based on the KEYNOTE-522 clinical data, the pCR rate was 64.8% in the Keytruda arm compared to 51.2% in the control arm, representing an absolute improvement of approximately 13.6 percentage points. Furthermore, EFS improved by roughly 8 percentage points, and the overall survival rate improved by about 5 percentage points. Demonstrating these absolute benefit margins underscores a major breakthrough in therapeutic outcomes, making it a highly clinically meaningful finding.Q. Why is the T2N0 patient cohort frequently highlighted in discussions regarding TNBC?T2N0 defines a case where the tumor size spans 2 to 5 cm with node-negative status. Patients often feel reassured because it is classified as Stage IIA, a relatively early stage. However, even within the same clinical stage, TNBC carries a profoundly higher risk of recurrence compared to other subtypes, such as hormone receptor-positive breast cancer.While the stage of the cancer is important, TNBC carries the risk of a poor prognosis and aggressive biological phenotype that even Stage IIA patients are classified into a high-risk group with an elevated risk of recurrence. Consequently, formulating an aggressive treatment strategy is essentialQ. How do you evaluate the clinical significance of Keytruda demonstrating an OS benefit?Demonstrating an OS benefit in early-stage curative settings is incredibly difficult. It requires proving that a therapy extends actual patient survival, rather than merely delaying disease recurrence.Certain therapies may successfully prolong the time to recurrence, but once the disease recurs, the biological characteristics of the tumor can shift aggressively, preventing extended patient survival. In those situations, an OS benefit is absent.In contrast, the validation of an OS benefit implies that early-intervention treatment successfully translates into a potential cure for a substantial proportion of patients, or at the very least, prolongs overall life expectancy even if the disease eventually recurs.Because cancer directly threatens life, the absolute benchmark and ultimate objective of all oncology treatments is to extend survival as much as possible. Thus, improving overall survival holds significance, demonstrating that the therapy has successfully achieved the gold standard goal of oncological intervention.Q. What do you consider to be the most noteworthy findings from the subgroup analysis?The fact that consistent outcomes were demonstrated across nearly all subgroups is highly meaningful. An especially intriguing aspect is the divergence between metastatic TNBC and early-stage TNBC data.In the metastatic setting, Keytruda's efficacy was confirmed exclusively in PD-L1-positive patients. However, in early-stage TNBC, pCR and EFS improvements were achieved regardless of PD-L1 expression status.This means that early-stage TNBC may possess distinct immunological profiles compared to the metastatic stage, suggesting that Keytruda-based regimens function more effectively when deployed early in the disease stage.Q. Why is the integrated therapeutic approach of continuing perioperative adjuvant therapy so crucial in early-stage TNBC?Previously, if a patient achieved pCR following neoadjuvant chemotherapy, further post-operative systemic treatment was frequently omitted. However, the KEYNOTE-522 study design mandated that even patients achieving pCR continue receiving adjuvant Keytruda post-surgery. Driven by these data, current guidelines recommend maintaining therapy unless precluded by significant adverse events.Notably, highly meaningful outcomes were confirmed in the non-pCR cohort. While this subpopulation historically carries a dismal prognosis, the inclusion of Keytruda demonstrated a trend toward improved survival outcomes. This strongly suggests that maintaining adjuvant therapy plays a critical role in managing residual disease burdens and mitigating the risk of recurrence.Keytruda's ability to fundamentally transform treatment outcomes across the entire TNBC continuum (from early-stage to metastatic disease) is significant. The observable decline in recurring patients compared to the past directly translates to lives saved, which is why its clinical value is so deeply felt on the ground.Q. How do you view the current reimbursement landscape and the challenges ahead?Currently, Keytruda is not reimbursed for this indication; partial reimbursement is restricted only to the backbone cytotoxic chemotherapies used in the combination regimen. While this alleviates a fraction of the cost, the out-of-pocket financial burden on patients remains substantial.The crucial factor we must not overlook is the societal and economic value of a clinical cure. Achieving a cure goes beyond the mere eradication of cancer cells; it represents returning a patient fully to society. When a patient is cured, it eliminates the massive future medical expenditures and drug costs associated with recurrence, while preserving the economic and social productivity that would otherwise be lost.In South Korea, a stringent threshold demand high standard for OS data for early-stage indications due to fiscal constraints. However, capturing definitive OS data requires an extended timeline, and while waiting for those results, a significant number of patients miss their critical window for a cure.While managing metastatic disease is vital, I personally believe that curative-intent treatment in the early-stage setting should take precedence. This is particularly justifiable because therapies deployed in the neoadjuvant setting have a fixed number of treatment cycles, allowing total healthcare expenditures to be capped and predicted in advance.Therefore, as a realistic alternative, if budget impact is the primary hurdle delaying full reimbursement, health authorities should actively explore mechanisms to enhance patient access, such as implementing partial reimbursement structure or adjusting patient co-payment tiers to a realistically affordable level.Allowing regulatory and institutional flexibility by taking into account the manageable financial thresholds for individuals confronting critical illnesses will serve as a practical solution to improve market access and patient drug availability for cancer patients.
- Opinion
- "New triple-combination therapy Levosartan Plus for hypertension"
- by Kim, Jin-Gu May 20, 2026 02:28pm
- Ahngook Pharmaceutical recently launched ‘Levosartan Plus Tab’, a triple combination therapy for hypertension. The product contains valsartan (an ARB) + S-amlodipine (a CCB) + indapamide (a diuretic). It is the first time this active pharmaceutical ingredient (API) combination has been approved in South Korea.Professor Seok-Min Kang of the Division of Cardiology at Severance Hospital, who led the clinical trial for regulatory approval, stated, “As the comorbidities of patients with hypertension become increasingly diverse, the importance of combining drugs with different mechanisms of action (MOAs) is growing. It will be highly useful, particularly for elderly patients or high-risk hypertensive patients with multiple underlying conditions.”Korea's first triple combination hypertension therapy, additional blood pressure-lowering efficacy compared to dual therapyProfessor Seok-Min Kang of the Division of Cardiology at Severance HospitalThe approval basis of trial for Levosartan Plus Tab was conducted over 3 years, starting in April 2022, and enrolled 306 hypertensive patients across 30 hospitals in South Korea. The study evaluated the incremental blood pressure-lowering efficacy of the triple combination therapy compared with conventional ARB·CCB dual fixed-dose combinations.The trial results demonstrated that Levosartan Plus Tab achieved an additional reduction of 6.3 mmHg in systolic blood pressure (SBP) and 3.69 mmHg in diastolic blood pressure (DBP) compared to the control group (dual combination). After 10 weeks, the blood pressure normalization rate in the investigational group was statistically significantly higher than that of the control group.Professor Kang said, “Tertiary hospitals see many high-risk hypertensive patients with various comorbidities such as diabetes, chronic kidney disease (CKD), stroke, and myocardial infarction (MI), making blood pressure management challenging with single-mechanism therapies alone," and added, "This clinical trial confirmed that the combination of three components with distinct MOAs offers incremental efficacy in controlling blood pressure in actual Korean hypertensive patients.”“Indapamide lowers risk of electrolyte imbalance aberrations...Synergy with valsartan and S-amlodipine”The most differentiating component in this combination is the diuretic, indapamide. Previously, the South Korean market for hypertension combination drugs predominantly utilized diuretics from the chlorthalidone or hydrochlorothiazide classes.Professor Kang cited the HYVET (Hypertension in the Very Elderly Trial) study as evidence for indapamide. Published in 2008, the study demonstrated that indapamide-based treatment reduced the ▲risk of mortality ▲fatal stroke ▲heart failure incidence ▲cardiovascular events compared to placebo. “In elderly hypertensive patients, indapamide-based therapy showed positive outcomes not only in blood pressure control but also in terms of cardiovascular prognosis,” Professor Kang explained.Professor Kang highlighted safety as a key advantage of indapamide. He explained that while conventional diuretics often pose a burden to elderly patients by lowering serum sodium and potassium levels, indapamide carries a relatively lower risk of such adverse effects.“While chlorthalidone offers potent antihypertensive efficacy, it can induce hyponatremia and hypokalemia in some elderly patients,” Professor Kang said. “In contrast, indapamide tends to be used stably in clinical practice.” Kang further emphasized, “The risk of metabolic side effects, such as elevated cholesterol, is also relatively low, making it highly applicable for hypertensive patients with concurrent hyperlipidemia.”The other two components, valsartan and S-amlodipine, are also evaluated as having distinct therapeutic roles. Professor Kang anticipated synergistic effects arising from the unique strengths of each component.“Amlodipine is a long-established CCB-class antihypertensive drug, but it can cause side effects like edema in elderly patients,” Professor Kang said. “In contrast, because S-amlodipine isolates only the active S-enantiomer responsible for lowering blood pressure, it carries a lower risk of adverse events such as edema or facial flushing compared to conventional amlodipine.”Regarding valsartan, Kang noted, “It is a drug with significant clinical evidence. In addition to lowering blood pressure, valsartan acts as an RAS (renin-angiotensin system) blocker, providing renal and cerebral protection. It can be utilized with a relatively stable safety profile even in patients with early-stage diabetes or those with a high metabolic risk profile.”“Complementary actions of three components... Expected to benefit elderly and high-risk hypertensive patients”Professor Kang projected that the new combination therapy containing valsartan + S-amlodipine + indapamide would benefit hypertensive patients who are elderly or present with underlying comorbidities. “It could be considered a preferred option for hypertensive patients with early-stage diabetes, obesity, or chronic kidney disease,” Professor Kang said. “It is also suitable for patients who previously suffered from ankle edema when using standard CCBs.”Professor Kang noted that the competitive edge of this therapy among the numerous existing hypertension combinations lies in its drug synergy. “It is designed for stable blood pressure control with S-amlodipine, the enhanced antihypertensive efficacy of indapamide, and the long-term clinical evidence and organoprotective effects of valsartan to complement one another.,” Professor Kang assessed. “It is a combination designed not just for efficacy in lowering blood pressure, but also taking into account real-world clinical experience.”Professor Kang also anticipated improvements in patient medication adherence. “Most hypertensive patients are elderly and take a load of medicines,” Professor Kang noted. “Taking a single pill is far more convenient than taking three separate medications," and concluded that "This will improve patient adherence, leading to a reduction in cardiovascular events.”
- Opinion
- "Eliminating generic pharma's shared bio-equivalence·illegal CSO"
- by Lee, Jeong-Hwan May 19, 2026 11:08am
- Won-jun Jo, Chief Representative for Health and Welfare of the Democratic Party's Policy Committee"The goal of the Democratic Party’s drug pricing system reform is not simply to reduce the National Health Insurance budget by cutting generic prices. The goal is to eliminate the space for paper-company pharmaceutical companies and free-riders that parasitize the pharmaceutical ecosystem, thereby establishing an industry order in which companies that properly manufacture and invest in novel drugs and supply unstable medicines are dramatically rewarded. This is also a principle we have firmly held in our general and presidential election pledges. Now that the reform plan has been finalized, the ruling party will work with the government to complete the remaining puzzle pieces of the drug pricing system through the abolition of the generic '1+3' shared bioequivalence system and follow-up measures to regulate unsound CSOs (pharmaceutical sales marketing agencies)."As the government finalized the broad framework and key details of the drug pricing system reform plan, the Democratic Party of Korea drew attention by expressing a strong determination to accelerate policies aimed at eliminating illegal rebates through the abolition of the generic 1+3 shared bioequivalence test system and the regulation of poor CSOs to complete the mission of "pharmaceutical and biotech industry innovation."By lowering the generic drug price calculation rate from 53.55% to 45% and strengthening selective and differential incentives compared to the past for innovative pharmaceutical companies, semi-innovative pharmaceutical companies, and companies contributing to supply-unstable medicines, the party intends to thoroughly exclude name-only pharmaceutical companies from the market that do not align with the values of pharmaceutical industry development, healthy employment and job creation, and the establishment of a sound medicine distribution structure.On the 17th, Won-jun Jo, Chief Representative for Health and Welfare of the Democratic Party's Policy Committee, met with DailyPharm and expressed, "Starting with the Ministry of Health and Welfare's drug pricing system reform plan, we are discussing follow-up policies that can send a clear and unambiguous message to the pharmaceutical and biotech industry, encompassing both novel drugs and generics, as well as the CSO industry."Jo evaluated that the Ministry of Health and Welfare's drug pricing system reform plan, which passed the Health Insurance Policy Review Committee and is set for implementation this year, deleted remaining inefficiencies and irrationalities while presenting a future vision for South Korea's pharmaceutical industry to pursue.The aim is to smartly restructure the reward system for pharmaceutical companies that contribute to novel drug research and development (R&D), the stable supply of essential medicines, and the growth of the national pharmaceutical industry, so that the nation and its citizens achieve a tangible level of practicality they can directly perceive."Novel Drug National Health Insurance Reimbursement, from an 'Admissions Quota System' to a 'Graduation Quota System'Jo explained that the discussions and designs for the drug pricing system reform with the Ministry of Health and Welfare (MOHW) focused primarily on significantly narrowing the gap between the public and novel drugs under limited health insurance budget conditions, and satisfying the social demand to resolve the issue of essential medicines that frequently go out of stock due to supply instability.Because the expansion of public access to novel drugs was incorporated into the reform plan, some civil and patient advocacy groups raised concerns that it might grant excessive privileges to global pharmaceutical companies focused on novel drugs, a perspective Jo believes should also be adequately acknowledged.In particular, Jo emphasized that the speed of implementing health insurance reimbursement to novel drugs is not the only factor that is increasing. He stated that, following the rapid reimbursement of a novel drug, a follow-up policy based on a mechanism to remove it from reimbursement immediately will be implemented if its drug efficacy cannot be proven through RWD.Jo said, "Until now, the barrier to entering novel drug reimbursement was high, and once a drug received reimbursement, it was a structure where reimbursement was continuously recognized thereafter. There were criticisms that this system was actually more irrational," and explained. "A judgment was made that it is more efficient to change the reimbursement barriers and criteria to be relatively flexible, but transition to a system where reimbursement is deleted if real-world prescription efficacy data is not clear during post-evaluations."He added, "We will proceed with follow-up work to prepare policies capable of determining reimbursement ejection based on real-world data. This is a package that the drug pricing system reform plan must accompany. To use a simple analogy to the college admission system, we are transitioning novel drug reimbursement from an admissions quota system to a graduation quota system. It changes to a graduation quota system where reimbursement cannot be maintained unless clear evidence of drug efficacy is proven after entering reimbursement.""Free-riding pharmaceutical companies must be sorted out for good generics to distribute"Regarding the significance of the generic drug pricing system reform, Jo summarized it as meaning "there are no drug prices to give to free-riding pharmaceutical companies.""Can a company that does not perform its own bioequivalence testing, its own clinical trials, or even its own direct manufacturing be called a pharmaceutical company?" Jo asked and assessed that "If you give the same drug price to a consignment pharmaceutical company simply because it has the same ingredient, that company has no reason to invest in personnel or spend money on infrastructure. Consequently, they become entirely consumed by maximizing generic sales competitiveness, which deteriorates into a structure that inevitably links to illegal rebates."Jo noted, "The major meaning of the generic reform plan is not about cutting drug prices, but rather about rewarding only those pharmaceutical companies that manufacture proper generics with a proper drug price. We believed a policy response was needed to address whether it is right to continue embracing consignment generics within the health insurance system. Therefore, we adjusted and newly established criteria for innovative and semi-innovative pharmaceutical companies, and embedded regulations in the reform plan that can yield benefits for companies contributing to supply-unstable medicines."Regarding the reduction of the generic calculation rate to 45%, Jo evaluated, "Although it may not be completely satisfactory to either the government or the pharmaceutical industry, an agreement was reached at a level that cannot be viewed as fatal to either side at the same time.""The pharmaceutical industry demanded 48% as a baseline margin, while the MOHW discussed the low 40% range. Looking only at the surface, it is the product of a social consensus, and political circles adjust aspects," he said. "It was also determined at a median level between the calculation values of Japan and France, which were referenced during the system design. This is why the pharmaceutical industry, which had major anxieties, was able to say after the system was finalized that it was difficult. They must endure a portion of it."Jo stated that the "graduation quota system" for novel drug reimbursement, the abolition of the 1+3 consignment generic system, and the eradication of illegal CSO rebates are the path the domestic pharmaceutical industry must take."Abolition of the '1+3' shared bioequivalence system is the goal"Jo asserted with confidence that the generic consignment bioequivalence system must be completely abolished so that paper-company pharmaceutical companies that free-ride on pharmaceutical industry development and the national health insurance budget disappear, establishing a pharmaceutical industry environment where only genuine pharmaceutical companies receive justified rewards.Jo's opinion that the current method, which allows three shared consignment pharmaceutical companies for every one pharmaceutical company performing a generic bioequivalence test, is a contradictory policy that stands at the opposite pole of the reformed drug pricing system.Jo announced that he will take the necessary legislative and administrative steps, alongside the MOHW and the Ministry of Food and Drug Safety, to implement a system that allows only a single generic per original medicine. This policy is expected to exert a significant impact on the overall structure of the domestic pharmaceutical industry, increasing the need to focus on future National Assembly legislation and government administrative movements."Currently, the 1+3 consignment bioequivalence generic system is permitted, but the rationale for why identical health insurance reimbursement drug prices should be given to three consignment generic items cannot be explained by any logic. It completely runs counter to the philosophy of the reformed drug pricing system," Jo emphasized. "In the past, it carried the meaning of partially cleaning up the market as a transitional phase, shifting from permitting unlimited bioequivalence tests to restricting it to 1+3, but now, the biggest characteristic of the reformed drug pricing system is that it will not give drug prices to pharmaceutical companies that free-ride by permitting generic consignment bioequivalence and manufacturing."Jo pointed out, "The consignment bioequivalence system has reached the point where it must be abolished. Previously, the MFDS also stated its position when announcing the 1+3 system that it was a temporary and provisional allowance. Some argue that the abolition of 1+3 will lead to job reductions. It is questionable what kind of industrial or national production consignment generic companies, which have a large proportion of paper companies, induce, or what employment creation effects they demonstrate.""Rebates exploiting rogue CSOs are evolving...We will eliminate these cases"Jo cited the elimination of CSO rebates as one of the critical follow-up measures that must be implemented after the drug pricing reform.Jo stated that, alongside the ejection of free-riding consignment pharmaceutical companies, regulations must be placed on malpractice in which some pharmaceutical companies exploit CSOs to continue illegal rebate sales operations to secure unfair profits, thereby amplifying the effects of the reformed drug pricing system."For good generics made by real pharmaceutical companies to be properly distributed in the market and for citizens to take their medications, the next targets for restructuring are unsound CSOs and the pharmaceutical companies that exploit them," Jo pointed out. "Like an open secret, some pharmaceutical companies select and operate with CSOs as indirect actors to diversify the risks and responsibilities of illegal rebates. These CSOs operate under a subcontracting and further re-subcontracting structure, ultimately making it ambiguous as to who bears the final liability for the rebate activity."Accordingly, he introduced, "Recently, some hospitals and directors have been disrupting the order of the sound medicine market by operating family CSOs as a method of evasion for family business succession to secure illegal profits. We are contemplating measures to strengthen CSO compliance alongside the Ministry of Health and Welfare. One of the measures under consideration is making it fundamentally impossible for a pharmaceutical company to cut off its relationship with a CSO to evade responsibility when a rebate is detected."In conclusion, Jo said, "We will strengthen regulations on malpractice CSOs through a joint penalty system for pharmaceutical companies and CSOs to eliminate problems where CSOs make it impossible to trace the origin of a rebate by subcontracting and re-subcontracting, and pharmaceutical companies cut relationships and deflect responsibility by blaming the CSO. Legislation that clarifies the mutual chain of responsibility between a pharmaceutical company and its contracted CSO will follow to support the success of the drug pricing reform plan."
- Opinion
- ‘Need to change perceptions on menopausal hormone therapy’
- by Son, Hyung Min May 18, 2026 09:11am
- With the US Food and Drug Administration (FDA) recently removing the Black Box Warning imposed on menopausal hormone therapy (MHT) products, the likelihood of a shift in perception is growing within Korea’s obstetrics and gynecology clinical field.While there has long been a strong tendency to avoid treatment due to concerns about the risk of breast cancer and cardiovascular disease, there is now a growing emphasis on the need for personalized treatment that takes into account the patient’s age, time of menopause, and risk factors.In particular, experts pointed out that the findings of the US Women’s Health Initiative (WHI) study had been excessively generalized to women in early menopause, and stressed that the long-term health benefits of early treatment, such as the prevention of cardiovascular disease, osteoporosis, and dementia, should also be considered.In a recent meeting with DailyPharm, Eun Sil Lee, Professor of Obstetrics and Gynecology at Soonchunhyang University Seoul Hospital, and Tae-Hee Kim, Professor of Obstetrics and Gynecology at Soonchunhyang University Hospital Bucheon, assessed that this FDA action could serve as an opportunity to fundamentally redefine existing perceptions of MHT, going beyond the mere removal of warning labels.(From the left) Professor Eun Sil Lee (Obstetrics and Gynecology, Soonchunhyang University Seoul Hospital) and Professor Tae-Hee Kim (Obstetrics and Gynecology, Soonchunhyang University Hospital Bucheon)The two professors particularly pointed out that although the 2002 WHI study was conducted on a patient population different from actual women in early menopause, the findings were subsequently applied uniformly to women of all ages, creating excessive fear toward hormone therapy.Based on the study results, the FDA introduced Black Box Warnings for MHT products in 2003. Following this, concerns over breast cancer, cardiovascular disease, and dementia risks spread rapidly, causing hormone therapy prescriptions to decline sharply worldwide. However, as more age-specific and menopause timing-based reanalyses accumulated in recent years, the FDA initiated procedures last November to remove the warning.Experts point out that the WHI study results were overgeneralized.The WHI study included women with an average age of 63, many of whom already had a significant number of risk factors for cardiovascular disease. Another limitation cited is that the study used a combination of hormones that is no longer widely used today. Subsequent age-specific analyses showed that for women who began treatment within 10 years of menopause, particularly those in their 50s, there was no clear increase in the risk of cardiovascular disease or dementia, and some studies even suggested possible preventive effects.In practice, MHT has long been used as a representative menopause management therapy, having been proven effective not only in alleviating menopausal symptoms such as hot flashes, sleep disturbances, and depression but also in preventing osteoporosis. However, following the publication of the WHI study, concerns about breast cancer risk spread rapidly, leading to a strong trend in Korea toward discontinuing or avoiding the treatment.Recently, there has been growing discussion that MHT should be reevaluated from a “well-aging” perspective, one that goes beyond simple symptom management to include cardiovascular health, osteoporosis prevention, and the management of healthy life expectancy. As life expectancy increases and women spend longer periods living after menopause, experts argue that both risks and benefits of treatment should be evaluated in balance.The two professors emphasized, “MHT should not be oversimplified solely in terms of breast cancer risk. It should instead be approached from the perspective of personalized treatment that comprehensively considers patient age, menopausal timing, and overall health status. When treatment begins at the appropriate time, positive effects can be expected not only for quality of life improvement but also for long-term health management.”Q. How do you evaluate the FDA’s recent removal of the MHT Black Box Warning?Professor Tae-Hee Kim (Obstetrics and Gynecology, Soonchunhyang University Hospital Bucheon)Professor Tae-Hee Kim: I view this FDA action as an important opportunity to reevaluate the previously excessive perception of MHT risks based on evidence.The patients included in the WHI study had a median age of 63 and included women with cardiovascular risk factors. They differed from actual women in early menopause who typically begin hormone therapy. Moreover, the study used hormone combinations that are rarely used today, making it difficult to generalize the results to all patients.I think this decision carries significance in reorganizing overly emphasized risks so that women in early menopause who may benefit from hormone therapy do not avoid treatment excessively.”Professor Eun Sil Lee: The previous black box warning stated that prescribing MHT increased the risk of breast cancer, cardiovascular disease, and dementia, which significantly heightened patients’ fears. In fact, the frequency of hormone therapy use decreased significantly following the WHI study.However, subsequent age-specific analyses yielded different results. For women in their 50s who began treatment within 10 years of menopause, there was no clear increase in risk. On the contrary, the possibility of preventing cardiovascular disease or dementia was raised. Ultimately, this means that the timing of when hormone therapy is started is what matters.Q. How should the safety of MHT be evaluated?Professor Tae-Hee Kim: Previously, there was a strong perception that taking hormones increased the risk of cardiovascular disease and dementia, but in fact, these findings should be viewed as results from women who started treatment in their 60s and 70s.On the other hand, data is accumulating showing that starting treatment in one’s 50s, during the early stages of menopause, may actually have preventive effects against cardiovascular disease and dementia. Ultimately, the key issue is not simply whether or not to take hormones.Factors such as age, menopausal timing, and cardiovascular risk factors must all be considered comprehensively. I believe safety is determined by individualized treatment strategies tailored to each patient.Professor Eun Sil Lee: I believe the most important factors when evaluating safety are the patient’s age and the timing of menopause.In reality, women in the early stages of menopause often do not have a relatively high risk of cardiovascular disease. Rather, during this period, as hormone levels drop sharply, vascular health deteriorates, and changes such as decreased bone density, sleep disorders, and feelings of depression begin to manifest in earnest.Conversely, if a patient has already progressed into her 60s with advanced atherosclerosis, the approach may differ. In advanced atherosclerosis, hormone therapy could potentially affect thrombosis risk. In the end, the key issue is who starts treatment and when.In actual clinical practice, many patients with severe menopausal symptoms hesitated to pursue treatment due to fears such as ‘Won’t this increase my dementia risk?’ or ‘Won’t this cause cardiovascular disease?’ But recently, the concept of individualized treatment considering age, risk level, and menopausal timing has become increasingly important.Ultimately, I believe the safety of MHT is not an issue that can be explained in a one-size-fits-all manner; it must be assessed by comprehensively considering the patient’s health status and the timing of treatment.Q. How are differences in safety between products distinguished in actual clinical practice?Professor Eun Sil Lee: The approach to hormone therapy fundamentally differs depending on whether the patient has a uterus. Women without a uterus can use estrogen-only therapy, but women with a uterus must use progesterone in combination to prevent endometrial cancer.The characteristics of treatment differ depending on which progesterone is used. Appropriate therapy inevitably varies according to patient age, symptoms, risk level, and preference.Professor Tae-Hee Kim: Rather than saying a specific product is absolutely better, it is more accurate to view each hormone therapy as having distinct characteristics.It is important to select the most suitable medication by considering the patient’s lifestyle, symptoms, and health status. Ultimately, individualized treatment through consultation with a specialist is key.Q. How do you evaluate the breast cancer risk associated with MHT prescriptions?Professor Eun Sil Lee (Obstetrics and Gynecology, Soonchunhyang University Seoul Hospital)Professor Eun Sil Lee: In reality, differences exist depending on the medication. European studies showed that combinations of estrogen and natural progesterone did not demonstrate a clear increase in breast cancer, while some synthetic progesterone combinations showed tendencies toward increased risk.However, even if long-term use carries some increased risk, the absolute risk itself is interpreted as not very large. Above all, regular screenings are crucial.Women receiving hormone therapy tend to undergo regular screenings more consistently, and management is possible through early detection. Ultimately, I think accurate explanations are needed so patients do not abandon treatment based solely on vague fear.Professor Tae-Hee Kim: Many women have a vague fear that taking hormone therapy will cause breast cancer. But actual data show that the issue is not that simple.Even in the WHI study, women without a uterus did not show an increase, but rather a tendency toward reduced breast cancer incidence. European studies also found differences in breast cancer risk according to progesterone type. Some medications showed no significant increase.Of course, it cannot be said that taking hormones absolutely prevents breast cancer. However, the important point is that breast cancer mortality did not increase. In fact, overall mortality was lower.Benefits such as improved quality of life, fracture prevention, and cardiovascular disease prevention must also be considered together. Individualized treatment based on family history and risk level is important.Q. How do you predict MHT prescriptions will change in the Korean market going forward?Professor Tae-Hee Kim: I believe changes in perception toward MHT will clearly emerge in Korea as well. In particular, as life expectancy increases, interest is continuing to grow not only in living longer, but in aging healthily—that is, in ‘well-aging’ and ‘anti-aging.’Women now live for more than 30 to 40 years after menopause. Ultimately, how healthily this period is managed has become extremely important. From that perspective, hormone therapy should be viewed not merely as symptom control for hot flashes or sleep disorders, but as part of a healthy lifespan management strategy.Most important is the timing of treatment initiation. Starting treatment within 10 years after menopause or before age 60 is absolutely advantageous. Diseases such as cardiovascular disease, dementia, and osteoporosis become difficult to reverse once they progress. Therefore, we must approach them from a preventive perspective, which requires starting management from the early stages of menopause.In actual clinical practice, many patients experience major declines in quality of life due to osteoporotic fractures, fall risk, sleep problems, and joint pain. Hormone therapy can help improve these issues as well.Professor Eun Sil Lee: I believe the current prescribing environment is likely to expand further. However, rather than simply increasing prescriptions across the board, “personalized treatment” tailored to each patient’s characteristics will become more important.After menopause, vascular health deteriorates rapidly due to a decrease in estrogen. Atherosclerosis begins to progress, and bone density also decreases rapidly. Therefore, in women in the early stages of menopause, hormone therapy can play a positive role in preventing osteoporosis and maintaining vascular health.Conversely, the approach may differ for older women in whom atherosclerosis has already progressed significantly. Ultimately, this means that the patient’s age, vascular condition, and the timing of menopause must all be taken into account.Recently, the FDA has also emphasized the need for an approach that takes age and the timing of menopause into account. In fact, the FDA has recommended starting treatment within 10 years of menopause or before the age of 60.Most importantly, patient perception itself must change. Until now, the perception that ‘hormone therapy is always dangerous’ has been too strong. But now patients are beginning to think about both quality of life and healthy lifespan.Going forward, rather than simply enduring menopausal symptoms, interest in how to maintain health after menopause is likely to increase further. In that process, it will become important for patients to consult sufficiently with medical professionals and choose treatments suited to themselves.
