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- 2026-06-06 10:10:02
- 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.
- Opinion
- [Reporter's View] The dark side of improved diabetes med convenience
- by Son, Hyung Min May 14, 2026 09:28am
- "I lost OOkg with Wegovy," "My appetite completely vanished after taking Munjaro."Personal stories about obesity treatments are now easily seen on social media platforms like YouTube. Content detailing how much weight was lost, what the side effects were like, and which drugs are more effective is being consumed just like any other everyday lifestyle content.Most experts emphasize that obesity is not a simple issue of body shape but a chronic disease that requires medical treatment. In reality, obesity is linked to various metabolic disorders such as diabetes, cardiovascular disease, and fatty liver, necessitating a therapeutic approach that considers Body Mass Index (BMI) and the presence of comorbid conditions.However, the reality is that the perception of obesity treatments is increasingly shifting toward 'weight-loss drugs' rather than treatments for a disease.The pharmaceutical industry's emphasis on improving medication convenience has also played a significant role in this trend.The rapid expansion of the GLP-1 class obesity treatment market is due to the convenience of once-weekly administration. Compared to past treatments that required daily oral intake or injections, the burden of use has been significantly lowered, leading to expanded patient access and market growth.Improvements in medication convenience are evaluated as meaningful changes in terms of patient accessibility and treatment persistence. Indeed, reducing medication burden in chronic disease management improves treatment adherence and patient quality of life. Accordingly, the pharmaceutical industry continues to develop drugs that maintain efficacy for longer periods with fewer administrations.Currently, the pharmaceutical industry is accelerating the development of various forms of obesity drugs, including oral pills, once-monthly injections, and patches. In a situation where even injections are accepted without much hesitation, the threshold for use is likely to drop even further once new drugs with drastically improved convenience emerge.The problem is that improved medication convenience does not carry the same meaning as improved medication compliance.Medication compliance is a concept closer to a patient who consistently maintains therapy according to the proper use and dosage. However, in the current obesity treatment market, 'how easily it can be used' is emphasized first, while discussions on who should use it and how are relatively lacking.In the online market, health-functional foods and overseas direct-purchase products, some with names similar to those of GLP-1 agents, are spreading rapidly, even though they are unrelated. Some of these products are consumed for weight loss purposes despite lacking sufficient medical validation or safety assessments.Of course, there is no reason to deny the clinical value of obesity treatments themselves. GLP-1 class treatments are changing the paradigm of obesity management by accumulating diverse data, including reductions in cardiovascular disease risk beyond weight loss. They are undoubtedly an important option for patients who require treatment.As treatments become more popular, what needs to grow alongside the consumption craze is a clear understanding of medical treatment. As convenience and accessibility increase, social standards regarding prescription criteria and medical necessity must become clearer. At the very least, there is a need to guard against obesity treatments becoming firmly established as merely 'diet shots that anyone can easily administer.'
- Opinion
- [Desk’s View] Are Korean modified drugs really beneficial?
- by Lee, Tak-Sun May 11, 2026 09:18am
- Generics with modified formulations are currently the hottest trend in product development among domestic pharmaceutical companies. In particular, products that convert tablets into orally disintegrating tablets (ODTs) to improve ease of administration are steadily emerging.ODTs, which dissolve in the mouth, are undoubtedly convenient for elderly patients, children, and those with swallowing difficulties. For these patients, there is no reason not to welcome the product development efforts of domestic pharmaceutical companies.However, whether it is really necessary for multiple companies to simultaneously develop orally disintegrating tablets containing the same active ingredient remains well in question, given the relatively small target patient population.For example, in the case of pitavastatin ODTs used to treat hyperlipidemia, not only the originator but also numerous generic companies have entered development competition, even though the 2mg tablet market is already saturated with 42 products.Behind the competition in ODT development lies pricing. In Korea, drug prices are calculated based on the criteria of identical active ingredients, identical dosage forms, and identical strengths. Under the stepwise pricing system, if there are more than 20 identical formulations meeting these conditions on the market, the price of the next product to be listed is set 15% lower than the previous lowest price.Since there are already 42 pitavastatin 2mg tablets, prices are inevitably set lower than the current minimum of KRW 462. However, ODT formulations, being classified as different formulations, can receive the highest price of KRW 561 for that ingredient.However, one must consider whether charging the highest price with a different formulation can truly satisfy a company’s profit needs when the patient population itself is small. Moreover, if multiple pharmaceutical companies compete, the market share will inevitably shrink.Naturally, to meet their profit targets with orally disintegrating tablets, pharmaceutical companies will target general populations as well, not just those who have difficulty swallowing tablets. As a result, a significant number of general patients may end up being prescribed ODTs.If a patient taking two or more medications has different dosage forms for each, this may increase inconvenience, as the patient must swallow one pill with water and dissolve another to take it, creating additional hassle.This means that a drug designed for the convenience of a specific patient group may actually cause inconvenience for the general patient population. This is because the choice of medication rests solely with the medical staff.The development of pharmaceuticals with improved convenience is on the rise. Although the market for combination drugs, which combine multiple medications into a single formulation, is already saturated, new combinations continue to emerge. Incrementally modified combination drugs are also granted pricing premiums. If ODTs prove commercially successful, development will likely evolve further.Pharmacy shelves are already filled with such products, and pharmacists have identified Korean modified drugs as a growing inventory burden. Given that hundreds of millions of won have been invested in developing these drugs, this cannot help but be a waste of social resources.While the emergence of more convenient medications is a positive development for patients, too many products are being released in Korea relative to the size of the market. In this highly competitive environment, it is unclear whether formulation changes and combination products truly contribute to the sustainability of the national health insurance system.If drug pricing is driving this competition in product development, the government may need to reassess whether the current pricing system truly aligns with patient needs.
- Opinion
- [Reporter's View] Contradiction of "K-passing" and a new drug powerhouse
- by Lee, Jeong-Hwan May 06, 2026 03:28pm
- The President Lee Jae Myung administration is promoting the growth of the pharmaceutical and biotech industry with goals of 'Rising as a leading country in global pharmaceuticals,' 'Strengthening treatment accessibility for patients with severe and rare/intractable diseases,' and 'Expanding fair value compensation for innovative new drugs.'The government's stance on the end goal of the drug pricing system reform plan, which recently passed the Health Insurance Policy Review Committee, is to transform the inherent nature of Korea's pharmaceutical and biotech industry, aiming to 'develop new drugs·stably supply essential medicines·expand patient accessibility to reimbursement.'Despite the government's policy vision, South Korea is facing "New Drug Korea-Passing." The South Korean government is not immune to the phenomenon in which pharmaceutical companies that have developed innovative new drugs delay or abandon their launches in the Korean market.While "New Drug Korea-Passing" has long been practiced primarily by global pharmaceutical companies, the rapid improvement in domestic firms' drug development capabilities suggests a future in which Korean deciding to bypass Korea. One of these examples is Cenobamate (brand name Xcopri), a new epilepsy drug developed by SK Biopharmaceuticals and Dong-A ST.It is a contradiction that South Korea, while seeking to become a global pharmaceutical powerhouse, must now worry about the availability of patient treatment, given the "Korea-Passing" phenomenon.The bigger issue is that it is difficult to find any serious deliberation at the government level to establish a solution.The cause of "New Drug Korea-Passing" is "low National Health Insurance (NHI) reimbursement prices for new drugs." Criticism follows that Korea's maximum reimbursement prices for new drugs are only half the OECD average and about 1/30 of those in the United States.When pharmaceutical companies accept Korea's low drug prices, other countries may use them as a reference, leading companies to abandon the relatively small Korean market. Ultimately, the victims of these decisions are the patients who must bear the full burden.The reason the South Korean government tries to set new drug prices as low as possible is not entirely incomprehensible. Since they attempt to set prices using the NHI fund, composed of citizen contributions, as the sole source of financing, it is inevitably difficult to determine a price that fully reflects the value of an innovative drug.Ultimately, the conclusion is reached that to realize a pharmaceutical and biotech powerhouse and solve the "New Drug Korea-Passing" problem, substantial financial resources are required to set prices that reflect the proper value of new drugs.This means that government efforts to secure separate financial resources outside of the NHI fund to determine new drug prices are needed immediately. The solution to achieving both the conflicting tasks of securing the sustainability and soundness of NHI finances while strengthening patient access to medicines also involves breaking away from the single-source NHI funding structure.The consequence of failing to manage the national task and securing separate funds has consistently manifested as a reduction in pharmaceutical spending through generic drug price cuts, repeated in the same pattern every time. This is why criticism arises that, while intense strategic posturing continues between the Ministry of Health and Welfare (MOHW), global pharmaceutical companies, domestic pharmaceutical companies, and patient groups over how to distribute limited resources, only innocent generic companies are hit.Unless the structure that relies entirely on the NHI fund to expand innovative drug reimbursement, amid an era of super-aging and the increasing launch of ultra-expensive new drugs, is reformed, there is no place for the MOHW, the domestic pharmaceutical industry, or patients.Various methods for creating separate funds beyond the NHI can be discussed. These include establishing funds dedicated to ultra-expensive medicines, similar to the UK's Cancer Drugs Fund, or implementing policies that allow a portion of tobacco taxes or lottery proceeds to be used for innovative drug reimbursement.Legislative bills for such policies have been proposed in the National Assembly for over a decade. The key is the government's will. Responsibility should not be placed solely on the MOHW. It requires a policy decision from the Ministry of Economy and Finance, the Ministry of Planning and Budget. Furthermore, the Prime Minister and the President. Are they not the drivers who set the policy goals of leaping into a pharmaceutical and bio-tech powerhouse and strengthening patient access to new drugs?In the National Assembly, policy seminars calling for the rapid reimbursement of innovative new drugs and the expansion of reimbursed indications are held daily, and the heavy responsibility for solving the problem is habitually returned to the Bureau of Health Insurance Policy of the MOHW. Can we continue to demand a solution for the expansion of new drug reimbursement and the "Korea-Passing" problem from the MOHW alone?It is time for the fiscal authorities, besides the MOHW, to take the lead with proactive measures to solve the task of securing separate funds through social consensus, and to immediately resolve the contradiction where being a 'new drug powerhouse' and "Korea-Passing" coexist. The President's political slogan, "I'll do it," should not be an exception when it comes to strengthening access to innovative drug reimbursement and expanding financial resources.
- Opinion
- [Reporter’s View] Beyond generics to new drugs
- by Choi Da Eun Apr 30, 2026 08:24am
- The Korean pharmaceutical industry’s push into new drug development has reached a turning point. Companies are moving away from a business model centered on generics and contract manufacturing (CMO), expanding into next-generation anticancer drugs and obesity treatments, signaling a clear shift toward innovation-driven growth to improve the company’s structure with a focus on new drugs.Whereas it was once common to acquire candidate compounds from global pharmaceutical companies and focus on late-stage clinical trials or commercialization, there is now a growing movement to take the lead directly, from early discovery through Phase 1 and 2, and even late-stage clinical trials. This strategy aims to go beyond simply securing a pipeline to internalize the entire new drug development cycle.This shift is led by major pharmaceutical and biotech companies such as Hanmi Pharmaceutical, Daewoong Pharmaceutical, JW Pharmaceutical, HK inno.N, Celltrion, and Samsung Bioepis. These firms are diversifying portfolios across oncology, obesity, and immunology by expanding pipelines of new drug candidates.A notable trend is the growing emphasis on in-house development. Companies are increasingly attempting to internalize the entire R&D cycle, moving beyond simple pipeline acquisition toward full-spectrum innovation, from early-stage compound discovery through Phase 1 and 2 clinical trials, and on to late-stage clinical trials. This marks a strategic shift away from a focus on in-licensing toward internalizing the entire R&D cycle.For example, Celltrion and Samsung Bioepis are accelerating the development of antibody-drug conjugate (ADC) anticancer drugs, thereby expanding their footprint into the field of biopharmaceuticals. This is an attempt to leap to the next stage by leveraging the technological capabilities and capital accumulated through biosimilars.In particular, obesity treatments and anticancer drugs are emerging as next-generation growth engines. Although these are fields with fierce competition in the global market, they are also areas where the landscape can rapidly shift depending on technological innovation. Multi-mechanism-based obesity treatments and next-generation ADC anticancer drugs are cited as representative fields where domestic companies can compete based on their technological prowess.Hanmi Pharmaceutical is taking one of the most aggressive approaches, expanding both bispecific antibody oncology pipelines and obesity drug programs simultaneously. The company is aiming to secure global competitiveness by leveraging multi-mechanism obesity drugs and anticancer platforms as its two main pillars.JW Pharmaceutical has demonstrated the ability to independently advance late-stage development by bringing a gout treatment candidate to Phase 3. This is significant because it demonstrates that these companies have internalized development capabilities not just to acquire a pipeline, but to reach the stage immediately prior to commercialization.HK inno.N is strengthening its in-house R&D capabilities by combining the introduction of obesity drug candidates with an open innovation strategy. This is a hybrid strategy that leverages external technology while aiming to secure an independent pipeline in the long term.Chong Kun Dang is developing innovative drugs through its subsidiary Achelra, while Yuhan Corporation is advancing biologics via ImmuneOncia. These specialized subsidiaries aim to improve research efficiency and success rates.The strengthening of new drug development capabilities reflects both technological advancement and improved financial stability among Korean companies. However, the industry is still in a transitional phase. Some companies are balancing between in-licensing and in-house development, but cases where clinical trials successfully lead to commercialization remain limited. A gap between expectations and actual outcomes persists.Nevertheless, the reason domestic pharmaceutical companies are shifting course is clear. With generic drug price cuts and intensifying competition among contract manufacturing organizations (CMOs), the limits to growth under the existing business model have become evident. Ultimately, the prevailing view is that it is difficult to secure a meaningful foothold in the global market without proprietary new drugs.The fact that domestic pharmaceutical companies have entered a stage where they are charting their own course in new drug development is clearly a significant change. With accumulated manufacturing expertise, global expansion experience, and strengthening R&D infrastructure, the industry’s structure is gradually evolving.Whether the challenge of shifting the R&D structure from a focus on generics and biosimilars to new drugs will remain a temporary trend or become a turning point for securing a presence in the global market depends on clinical outcomes and commercialization capabilities.This effort is not merely business expansion but a structural transformation of the industry. Market evaluation should therefore consider both outcomes and the process of capability building. If this trend continues, the leap from a generic powerhouse to a powerhouse in new drug development will no longer be a distant prospect.
