- LOGIN
- MemberShip
- 2026-09-07 05:22:37
- InterView
- [Reporter’s View] Decade of drug price cuts ahead
- by Jung, Heung-Jun Sep 02, 2026 09:07am
- With the reassessment of listed drugs set to continue for a decade beginning next year, large-scale disruption from drug price cuts is expected to unfold on the front line every year.The government needs to put measures in place before price reductions under the reassessment begin next April. Preventing confusion over product returns and price-difference settlements after price cuts should also be part of the responsibilities that come with the latest drug pricing reform.Phase 1 drugs, which will undergo reassessment from next year through 2033, and Phase 2 drugs, scheduled for 2030 through 2036, will undergo phased annual price cuts of 2%.Under the system, prices set at 53.55% of the benchmark will gradually be reduced to 45%. Products that fail to meet the relevant criteria will have their prices reduced to 80% of the applied rate for that year.For individual products, the amount of each reduction may not appear substantial. The problem, however, is the sheer scale. With post-listing management now conducted on a regular schedule, thousands of products are expected to face price reductions every April or October.Although administrative attention is currently focused on determining which products will be subject to price cuts, once that process is complete, the market will have to contend with the disruption caused by the price adjustments themselves.Products facing price cuts in April and October will include not only those covered by the reassessment of listed drugs but also products subject to the price-volume linkage system under the regularized post-listing management framework.If the prices of thousands of drugs are cut simultaneously, pharmacies will inevitably seek large-scale settlements for price differences to protect themselves against inventory losses. If the government follows the same tight timelines used for previous drug price cuts, a wave of product returns across the market will be all but inevitable.The government should finalize and transparently announce the products subject to price cuts and their respective reduction rates at least one month in advance, giving pharmacies and distributors sufficient time to prepare procedures such as price-difference settlements without disruption.During the across-the-board price cuts in 2012, procedures for paper-based returns were established, and compensation for price differences was provided. Even so, the sheer number of affected products rendered disruption in the field unavoidable.The reassessment of listed drugs will affect the market over a lengthy 10-year period. Rather than a one-off shock, it will become an annual event affecting the market for a decade. Before the first round begins next year, the government therefore needs to establish a predictable and transparent buffer system.To this end, the government should work with organizations, including the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the Korea Pharmaceutical Distribution Association and the Korean Pharmaceutical Association to establish measures in advance. The quality of a drug pricing system depends not only on sophisticated formulas for determining new prices, but also on whether the system can operate without imposing unnecessary social costs and disruption on the market.
- InterView
- ArthRegen takes on regenerative medicine
- by Hwang, byoung woo Aug 31, 2026 08:58am
- "The ultimate destination of arthritis treatment is artificial joints. ArthRegen aims to become a company that provides regenerative medicine so that patients can avoid artificial joints.”As the aging population drives growing demand for joint disease treatment, artificial joint replacement has emerged as a key treatment option for arthritis. However, because the procedure replaces damaged tissue rather than regenerating it, patients still have limited options for preserving their natural joints.ArthRegen plans to bridge this gap through regenerative medicine. Dailypharm met with ArthRegen CEO Joon Ho Wang to discuss the company’s vision for bioartificial joints and its business strategy.Physician entrepreneurship… bridging the gap between research and treatmentJoon Ho Wang, CEO of ArthRegenWang, who leads ArthRegen, is both a clinician and researcher who has treated knee patients as an orthopedic surgery professor at Samsung Medical Center.After witnessing the limitations of existing treatments in practice and conducting regenerative medicine research for 20 years, Wang chose entrepreneurship as a means of translating his research into actual treatment technologies.His decision to establish the company stemmed from the disconnect between research findings and clinical practice.When the articular cartilage or meniscus is damaged, procedures such as suture, transplantation, osteotomy, and cartilage regeneration may be performed, but they have limitations in restoring the tissue’s original function. Even after all available treatments have been exhausted, joint damage may continue to progress and ultimately require artificial joint replacement. Watching these patients, Wang realized the need for new regenerative treatments.He continued his cell therapy and tissue engineering research through government-funded projects, but realized that academic papers alone could not produce treatments for use in patients, as advancing a product from cell production and preclinical testing to clinical trials and regulatory approval requires commercialization funding, specialized personnel, and manufacturing infrastructure.Wang said, “During my 20 years of research, I hoped the findings would be used to improve clinical practice, but in reality, a considerable gap remained unfilled. This is when I realized entrepreneurship was a necessary platform for delivering research findings to patients.”He added, “A physician’s role is to treat the patients who come to the clinic, but I believe entrepreneurship is about developing treatments for the many patients of the future whom I may never meet personally.”Human tissue products should come first…Company to develop 3 pipelines sequentiallyArthRegen’s pipeline consists of three pillars. The first is a cell therapy for articular cartilage regeneration. The therapy uses mesenchymal stem cells derived from Wharton's jelly inside the umbilical cord, formed into 3D spheroids to induce the regeneration of damaged cartilage.The company is focusing on the cells’ potential to modulate the damaged microenvironment within the joint and promote the formation of cartilage-like extracellular matrix.The second is an acellular tissue regeneration product that uses extracellular matrix obtained by removing cells from human meniscal tissue. The company cites the product’s composition as a differentiating feature. Unlike skin-derived extracellular matrix products, which are primarily composed of type I collagen, meniscus-derived material contains cartilage components such as type II collagen and glycosaminoglycans.ArthRegen plans to utilize this product in surgeries for articular cartilage and meniscus. The company views human tissue products as requiring a shorter period for market entry than new drugs or implantable medical devices, and is therefore pushing for commercialization first among its pipelines.Wang said, “Human tissue products follow a different development pathway from new drugs and medical devices that require clinical trials, and may therefore enter the market relatively quickly. We are developing the product to generate our first sales in 2027.”The company’s third pipeline is an AI-based, patient-specific 3D-bioprinted meniscal implant. The medical device analyzes images of the defect in a patient with meniscal loss and is designed and manufactured to fit the shape and structure of the individual defect.ArthRegen is studying the use of polycaprolactone (PCL), a biodegradable material, to reproduce the meniscus’s shock-absorbing and joint-protective functions. Because the company is developing the product as a Class IV implantable medical device, it must complete material selection, animal studies, and clinical trials. ArthRegen is targeting commercialization within 3-4 years.Production through external partnerships…Focus on development capabilitiesRather than building all of its own manufacturing facilities, ArthRegen has chosen to utilize the production and testing capabilities of specialized external companies. The company directly develops the pipeline concepts, target applications, product designs, and core technologies, while outsourcing production and testing.For its cell therapy, the company signed a contract development and manufacturing agreement with Matica Biolabs. Matica Biolabs is responsible for developing and operating the process for isolating Wharton’s jelly-derived mesenchymal stem cells and supports ArthRegen’s preclinical research.ArthRegen plans to establish the cell manufacturing process by mid-2027 and begin good laboratory practice-compliant preclinical studies required to enter clinical trials under the Ministry of Food and Drug Safety in the second half of the year. After completing domestic Phase I and II trials, it is also considering conducting a global Phase III trial, depending on its funding situation.The 3D-bioprinted meniscal implant is likewise being developed in partnership with a specialized company. ArthRegen is responsible for analyzing each patient’s defect, designing the implant and developing its clinical application, while combining these capabilities with the external partner’s 3D-printing and manufacturing expertise. After confirming the product’s function and safety in animal studies, the company may pursue joint development with a global medical device company or out-license the technology.Wang said, “It would be difficult for a startup to own all the facilities needed for cell therapy production, 3D printing, and preclinical testing. ArthRegen leads the product concept and technology, indications and design, while partnering with specialized companies on production.”ArthRegen’s long-term goal is to connect its 3 pipelines into a single joint regeneration system.The company will initially develop its human tissue product, cell therapy, and meniscal implant separately. Ultimately, however, it believes that complete tissue regeneration will require combining a scaffold on which cells can grow with a cell therapy.The company also plans to integrate AI-based joint assessment and defect analysis, patient-specific implant design and 3D bioprinting. In the longer term, it intends to incorporate robotic surgical technology that helps surgeons place the implant in the precise position for which it was designed.Wang emphasized, “ArthRegen is not simply a cell therapy or 3D-printed medical device company. We are pursuing a broader vision capable of changing the paradigm of joint treatment.”He added, “Our goal is to become a comprehensive joint regeneration company that connects AI-based diagnosis, patient-specific implant design and 3D printing, to ultimately robotic surgery.”.
- InterView
- [Reporter’s View] Hanmi lands big deals after a long-term R&D commitment
- by Cha, Ji-Hyun Aug 25, 2026 08:55am
- News reporting the management control dispute at Hanmi Pharmaceutical, which spanned over two years, required meetings with numerous stakeholders. Although each individual had different rationales and strategic directions, they shared one principle: the 'Sung-ki Lim legacy.' Each claimed a commitment to upholding the vision of the late founding chairman Sung-ki Lim, at the core of which lay the ambition to develop innovative novel drugs through research and development (R&D) and build a pharmaceutical powerhouse.Examining Hanmi's recent history offers a clearer view of what this internally emphasized 'Sung-ki Lim legacy' represents. Even amid the ongoing management conflict, Hanmi sustained its R&D investments and did not halt progress on its core pipeline assets. Although the corporate governance dispute persisted, the company ultimately instituted a professional executive management structure, establishing a framework to refocus on novel drug development.The outcomes of this R&D focus are now shining. On the 24th, Hanmi concluded its second mega out-licensing agreement of the year. After out-licensing the long-acting GLP-2 analog 'sonepeglutide' to Eli Lilly in May, the company licensed its novel obesity and metabolic disease candidate 'HM17321' to Roche Group's Genentech. The combined deal value of the two transactions exceeds KRW 5 trillion.Notably, the upfront payments are substantial. The upfront payment for the Genentech deal amounts to $190 million (KRW 262.9 billion), representing 8.2% of the total deal value. In its earlier agreement with Eli Lilly, Hanmi Pharm also secured $75 million (KRW 112.9 billion) upfront, accounting for approximately 6.0% of that contract. In this year alone, the upfront fees Hanmi secured across the two transactions have reached $265 million (KRW 375.8 billion). This upfront total surpasses Hanmi's entire operating profit for last year (KRW 257.8 billion) by 45.8%.Royalty and licensing sales also serve as financial resources for follow-on drug development. Last year, Hanmi's R&D expenditure reached KRW 229.0 billion. This represented 14.8% of Hanmi's total revenue and was the second-highest investment level among traditional domestic pharmaceutical companies, after Yuhan Corp. Backed by this R&D commitment, the company is also anticipating the commercialization of South Korea's first domestic GLP-1 class anti-obesity therapeutic, 'efpeglenatide,' in the second half of this year. In effect, Hanmi has established a virtuous cycle: reinvesting funds generated from out-licensing back into R&D to drive subsequent clinical and commercial milestones.In particular, Hanmi's latest mega-deal extends beyond positive news for an individual enterprise. The domestic pharmaceutical and biotech sector has been struggling with subdued investor sentiment and capital constraints. Moreover, as the market concentrated heavily on large-cap semiconductor equities, biotech shares were pushed out of the spotlight. Hanmi's case, where prolonged R&D commitment led to validation by global Big Pharma and substantial capital inflows, presents as a welcome signal for the broader industry.Hanmi has faced some difficult times over the past decade. After a successful domestic pharmaceutical out-licensing deal with Eli Lilly in 2015, the company endured painful setbacks, including discontinued clinical programs and returned asset rights. Nevertheless, it used these setbacks as a springboard to rebuild, generating new milestones along the way. Perhaps the 'Sung-ki Lim legacy' has been translated into this continued drive to challenge obstacles. Expectations remain high that Hanmi will carry this vision forward and achieve even greater results.
- InterView
- [Reporter’s View] The dementia drug efficacy dilemma
- by Son, Hyung Min Aug 20, 2026 09:23am
- A patient visits a hospital, feeling that their memory is not what it used to be. Tests show that the patient does not have dementia but has mild cognitive impairment. The patient then asks, “What medication should I start taking now?”This question is ridden with anxiety and fear, yet tinged with anticipation.The fear that the condition may progress to dementia is coupled with hope that doing something now might at least slow that progression. Even when patients cannot be certain how much a prescribed drug actually helps, they may still believe that “taking anything would be better than nothing.”The problem is that, when it comes to improving cognitive function, it is not easy to clearly distinguish that belief from the drug’s actual effect.On some days, patients may feel their mind clears up after taking a drug, while on others they may feel fine even without it. Memory and concentration can also vary depending on sleep, stress, and a person’s condition that day. It is difficult for patients and caregivers to discern whether the small changes they experience are the actual effects of the medication or just natural fluctuations."This issue is not unrelated to the fact that several drugs long used in Korea as cognitive enhancers have failed efficacy verifications.Acetyl-L-carnitine failed to demonstrate efficacy in a clinical reassessment, leading to the removal of its relevant indications, while oxiracetam also failed its clinical reassessment and exited the market. Choline alfoscerate, meanwhile, has been at the center of years of controversy and litigation over its reimbursement eligibility.However, a series of drugs continued to fill the void. Ginkgo biloba extract and porcine brain peptide preparations emerged as alternative treatments, while nicergoline, which had previously had a relatively limited presence, began attracting renewed attention in the prescription market.However, even these are facing scrutiny once again, with ginkgo biloba extracts and porcine brain peptide preparations also facing reassessments.The shift in prescriptions from acetyl-L-carnitine to oxiracetam and choline alfoscerate, and then again to drugs such as ginkgo biloba and nicergoline, is noteworthy. When one drug disappears, another takes its place, and once use of that drug increases, it too comes under scrutiny.It would be difficult to view this simply as a problem with the reassessment system. The National Health Insurance cannot be expected to continue covering drugs with unproven efficacy simply because they have been used for a long time. Nor can clinical utility be established solely based on patients’ perceptions that a drug is working. This is precisely why clinical reassessments and reassessments of reimbursement eligibility are necessary.Yet one question remains in dementia and cognitive impairment: What evidence should determine whether a treatment is effective? The difficulty of answering that question does not stem from drugs alone. Mechanisms underlying the onset and progression of dementia have yet to be fully elucidated.In Alzheimer’s disease, amyloid-beta accumulation and tau pathology are well-established key features. But the onset and progression of the disease cannot yet be explained through a single pathway. As neuroinflammation, vascular abnormalities, and metabolic changes have also been found to play a role, the understanding of Alzheimer’s disease has become increasingly complex.The representative amyloid hypothesis has also been the subject of long-standing controversy.Numerous drug candidates were developed in the hope that removing amyloid could treat Alzheimer’s disease, only to face repeated failures. Aduhelm (aducanumab) demonstrated a clear biological effect in reducing amyloid, yet remained mired in controversy over its clinical utility.The more recent Leqembi (lecanemab) has gone a step further. In addition to removing amyloid beta, it significantly slowed the decline in cognitive function and activities of daily living in patients with early Alzheimer’s disease, demonstrating its potential as a disease-modifying therapy.However, questions remain.Leqembi did not restore lost memory. It delayed progression of a disease that had already begun. Patients receiving treatment still experienced cognitive decline over time, but at a slower rate than those receiving placebo.The fact that removing amyloid does not completely halt disease progression illustrates the complexity of the onset and progression of Alzheimer’s disease.Safety is also a concern. Amyloid-targeting antibodies such as Leqembi can cause amyloid-related imaging abnormalities (ARIA), including brain edema and microhemorrhages, which require careful patient selection and repeated MRI monitoring.Ultimately, even with the latest dementia treatments, we once again confront the question of what constitutes an “effect.”In dementia treatment, efficacy may encompass not only directly improving cognitive function but also slowing deterioration and extending the period during which patients can maintain independent daily living. Yet determining how meaningful differences in clinical scores are in patients’ lives remains an issue requiring careful judgment.Ultimately, the dilemma surrounding cognitive enhancers converges on this very point. Changes in mild cognitive impairment and early dementia occur slowly and vary considerably among patients. Cognitive test results can also be affected by numerous factors, including sleep, psychological state, education level, and a patient’s condition on the day of testing.It is necessary to weed out drugs that do not work. But for a disease like dementia, where multiple pathological processes are involved in onset and progression and treatment goals range from “recovery” to “slowing progression,” it is worth asking whether a single yardstick is sufficient to determine whether a treatment works.The criteria for assessing treatment effects need to become more sophisticated, encompassing not only cognitive scores but also how long patients maintain independent daily living, how long progression to the next stage of disease is delayed, and how much the burden on patients and caregivers is reduced.With much still unknown about how dementia develops and progresses, the question is where to draw the line on what constitutes a meaningful treatment effect—and what evidence-based answers can be given to patients seeking reassurance and hope. Finding those answers is a task for both drug developers and regulators.
- InterView
- [Reporter’s View] Regarding the NHIS Special Judicial Police Act
- by Jung, Heung-Jun Aug 14, 2026 08:45am
- Legislation granting the National Health Insurance Service (NHIS) special judicial police authority is now just one step away from final passage in the National Assembly.Recent data submitted by the NHIS to Office of Rep. Jin-sook Jeon of the National Assembly's Health and Welfare Committee highlight the scale of financial losses caused by illegally established healthcare institutions. Uncollected losses to the National Health Insurance system from illegal medical institutions, including so-called "straw-owner hospitals" and pharmacies operating under borrowed pharmacist licenses, have reached KRW 2.65 trillion.Of the approximately KRW 2.9 trillion in reimbursement recovery orders issued, only about 9% has actually been recovered. In the case of license-rental pharmacies, 92.2% of the approximately KRW 705.6 billion ordered for recovery remains uncollected. These figures demonstrate the limitations of the current investigative framework and underscore the urgent need to grant the NHIS special judicial police authority.Recent amendments to the Criminal Procedure Act will eliminate prosecutors' supervisory authority over special judicial police officers. Some critics argue that, without prosecutorial oversight, granting such authority to the NHIS could lead to excessive investigations.Others have raised concerns about the legal expertise and investigative experience of NHIS personnel, warning of potential abuse stemming from insufficient professionalism.However, arguing that the proposal should be abandoned entirely simply because prosecutorial supervision is being eliminated or because investigators may lack experience is an overstatement. Leaving more than KRW 2.6 trillion in health insurance losses unchecked is not an acceptable option.The NHIS, for its part, must also make every effort to address these concerns. It has already established a dedicated task force and secured approval from fiscal authorities to add 31 investigative personnel, effectively completing the necessary organizational hardware.The next step is ensuring that current concerns never become reality. The NHIS must demonstrate its transparency and professionalism by establishing robust investigative guidelines that prevent human rights violations and abuse of authority, while providing intensive and ongoing legal and ethics training for investigators.The National Assembly has also begun strengthening the legislative framework, presenting a bill (Rep. Seo Mi-hwa) that would clarify investigative jurisdiction over illegally established and operated pharmacies.The National Assembly should no longer delay passage of the legislation because of peripheral concerns. Every delay simply allows further financial losses caused by illegal hospital and pharmacy operators.It is time to end the unproductive debate, pass the bill promptly, and close the loophole through which health insurance funds continue to leak. After that, it will be up to the NHIS—through thorough preparation—to prove that it can exercise its new authority responsibly.
- InterView
- [Reporter's View] Multi-branded generics...1+3 regulation outcomes
- by Lee, Jeong-Hwan Aug 12, 2026 09:22am
- Five years have passed since the South Korean government implemented the "1 (contract manufacturer) + 3 (consignment company) generic restriction regulation" to overhaul the proliferation of generic drugs and improve the domestic pharmaceutical industry's research and development (R&D) structure for novel drugs.By limiting the number of generic items that can be approved based on a single bioequivalence (BE) study dataset to one original contract manufacturer plus three consignment pharmaceutical companies, totaling four per dataset, the regulation created significant shockwaves across the pharmaceutical industry when first announced. At present, however, examining the domestic pharmaceutical market raises fundamental doubts about whether the structural proliferation of generic drugs has actually been resolved. The primary cause is that previously listed generics approved before the implementation of the regulation were not subject to retroactive application, leaving the reality intact. Generics under '1+4 or more' co-development structures still account for nearly 80% of the market. Multi-branded generics under 1+4 or more that had already secured authorization and market entry before the policy's implementation continue to maintain their market shares undiminished. As the Ministry of Health and Welfare (MOHW) implements its first generic drug price reduction policy in 14 years, price cuts are expected to apply across dozens of bundled generics, which is likely to alleviate the phenomenon of unrestricted market competition among multi-brand generics sharing the same active ingredient. Now, political leaders and the government must focus their legislative and administrative efforts on reasonably shifting the 1+3 joint bioequivalence regulation to the modern standard. This means considering the legislative need to tighten the 1+3 joint bioequivalence restriction to 1 or 1+1, while gathering feedback from the pharmaceutical industry on whether to partially relax the 1+3 rule for incrementally modified drugs (IMDs) and data-submission pharmaceuticals rather than simple generics. One-dimensional regulatory enhancement aimed solely at reducing the sheer number of generics risks creating side effects that could sever the entry ladder for small and medium-sized enterprises (SME) or venture drugmakers, companies that may lack full in-house development capabilities yet possess proprietary formulation technologies or potential for incremental improvements to pursue novel drugs or IMDs.Regulation must evolve beyond simple headcount slashing into a "detailed and nuanced structural reform." First, a categorized regulatory overhaul clearly distinguishing IMDs from simple generics is urgent. Subjecting IMDs, which demonstrate meaningful clinical improvements through fixed-dose combinations or formulation modifications, to the same joint bioequivalence and clinical trial criteria as standard generics undermines pharmaceutical R&D. A practical restructuring mechanism for previously listed generics must be established. Rather than stopping at simple caps on authorization counts, regulators must further refine differential drug pricing systems tied to Good Manufacturing Practice (GMP) compliance evaluations and self-conducted bioequivalence validation in connection with drug pricing system reforms.An economic incentive structure must be designed to encourage previously listed products that rely entirely on contract manufacturing with zero internal R&D investment to exit the market voluntarily. As the generic drug price reduction policy goes into effect this month (August), the vast majority of domestic pharmaceutical companies are not exempt from the financial impact of across-the-board price cuts, which are dropping baseline rates from 53.55% to 45%. To shift a distorted market environment where hundreds of generics are authorized per active ingredient and improve toward becoming a global novel drug powerhouse, detailed, surgical regulation that penetrates the domestic pharmaceutical landscape to separate genuine innovation from simple replication is essential. The MOHW and the Ministry of Food and Drug Safety (MFDS) must engage. They must build a well-balanced, multi-faceted administrative and policy roadmap capable of shaking the roots of the multi-brand generic structure.
- InterView
- [Reporter’s View] When intent doesn’t meet reality
- by Hwang, byoung woo Jul 22, 2026 08:50am
- While covering the issue of disinfectants used at pharmaceutical plants, the first thing that came to mind was the distance between regulatory necessity and real-world application.In the wake of South Korea’s deadly humidifier disinfectant scandal, few would dispute the need for tighter controls on chemicals and biocidal products. The intent of the system, which is to manage potentially hazardous substances in advance and establish clear standards for their use, is necessary.However, just because a system is designed with the right intentions does not mean it translates seamlessly into the field. Particularly in spaces like pharmaceutical manufacturing, where rigorous quality control systems are already in place, even minor changes in standards can lead to compounding procedural and validation burdens.On the surface, the issue appears straightforward. A biocidal product management system has been introduced, and pharmaceutical plants simply need to use disinfectants and sterilizing agents that meet the applicable standards. Yet, at pharmaceutical manufacturing sites, switching even a single disinfectant goes far beyond a simple change in procurement.This issue is unrelated to the ingredients or safety of the manufactured vaccines themselves, as the biocidal substances are not entering the vaccine drug substance or being mixed into finished products. The issue involves products used to disinfect manufacturing environments, including work areas, cleanrooms, and controlled areas at pharmaceutical plants.At pharmaceutical plants, disinfectants used to maintain aseptic conditions in work areas and cleanrooms are managed under Good Manufacturing Practice (GMP) standards. In the case of products such as vaccines and injectables, where aseptic control is particularly important, the manufacturing environment itself forms part of quality control.Therefore, every single disinfectant is managed according to the area and method of use, the amount applied, the replacement cycle, and relevant quality documentation. Before switching to a new product, manufacturers must verify that it provides the same disinfecting efficacy as the existing one and assess whether it may cause corrosion or reactivity issues with equipment or materials. Where necessary, cleaning and disinfection procedures, environmental monitoring standards, and standard operating procedures may also need to be revised.Nor can a product be used immediately at a GMP manufacturing site simply because it has received regulatory approval. A product that meets environmental safety standards is not necessarily the same as one suitable for maintaining an aseptic environment at a pharmaceutical plant.This is where gaps between the regulatory systems of different ministries become apparent. Products applied directly to the human body are regulated by the Ministry of Food and Drug Safety, while disinfectants used in manufacturing environments fall under the Ministry of Climate, Energy and Environment regulations. While the division of roles seems reasonable, the two domains do not neatly divide within the space of a pharmaceutical manufacturing site.From the Ministry of Climate, Energy and Environment’s perspective, such a product would be a biocidal product used at a workplace. From the Ministry of Food and Drug Safety’s perspective, however, it is a GMP-controlled element used to maintain the pharmaceutical manufacturing environment. The same product is viewed through two conflicting regulatory frameworks.This does not mean that safety regulations should be eased in any way, as the lessons of the humidifier disinfectant tragedy are clear. Rather, the application of safety regulations must be refined so that they do not give rise to new supply risks.For products such as influenza vaccines, which must be supplied during a specific period, even a minor change can become a burden. Replacing and validating a disinfectant takes time, and this may also create risks for production and release schedules.What is needed now is not a dispute over responsibility. The government should preserve the purpose of the regulations while establishing implementation standards that reflect the unique GMP requirements of pharmaceutical manufacturing sites. The industry, for its part, should not merely ask for grace periods, but should review the products in use and put systems in place to respond to the regulations.Regulations are becoming more stringent, yet sites that fall across ministerial boundaries are often left in regulatory blind spots. The issue of disinfectants used at pharmaceutical plants is one such example.It is time for the system to acknowledge the realities of the field and why changing a single disinfectant requires months of validation and paperwork.
- InterView
- [Reporter’s View] Role of MRs at a crossroads
- by Son, Hyung Min Jul 21, 2026 08:26am
- Early retirement programs (ERPs) are no longer an unfamiliar sight at the Korean affiliates of multinational pharmaceutical companies.Major drugmakers have repeatedly implemented workforce restructuring around their sales organizations, rendering ERPs an ongoing trend.Following BMS, MSD, and Takeda, Novartis has also begun reorganizing its operations, prompting various interpretations inside and outside the industry about the future of pharmaceutical field sales and the role of medical representatives at multinational companies.Some view the trend as a sign of the declining role of medical representatives. The role of medical representatives was long expected to diminish with the expansion of digital marketing and the rise of artificial intelligence (AI). Improving operational efficiency and reducing costs are also key drivers behind the ERPs.Others, however, point to repeated ERP implementations at companies with improving financial performance. From this perspective, they argue that recent changes cannot be explained by cost-cutting alone.In the past, a pharmaceutical company's competitiveness largely depended on how many healthcare professionals it could reach and how effectively it could promote its products. During the era when blockbuster cardiovascular drugs dominated the market, sales networks and field activities were the primary drivers of commercial success. Effectively communicating a product's advantages and building trust with physicians were paramount.Today, the market operates by different rules.As high-cost medicines, including oncology and rare disease therapies, account for a growing share of the market, competition has shifted from sales capabilities to clinical evidence. Biomarkers, treatment guidelines, and increasingly detailed reimbursement criteria have become the key factors influencing treatment decisions. Rather than personal rapport, the clinical significance of trial results, differentiation from existing therapies, and reimbursement status now determine a product's competitiveness. The industry has entered an era in which a single promising new drug can drive a company's growth.This is why many multinational pharmaceutical companies are actively reshaping their portfolios toward highly specialized therapeutic areas. As product portfolios evolve, competitive strategies and the role required for MRs are evolving as well. This explains why field sales organizations have become the focal point of organizational change.The shift is naturally reshaping pharmaceutical company structures. Specialized functions such as Medical Affairs, Medical Science Liaisons (MSLs), and Market Access (MA), which engage with healthcare professionals and government authorities, are playing increasingly important roles. In other words, sales activity is not disappearing; rather, many of the functions traditionally handled by medical representatives are now being performed by more specialized teams.Recent ERPs should also be viewed from this context. More important than workforce reductions themselves is the question of what capabilities companies are strengthening to adapt to the changing market. The role of sales continues to evolve as evidence-based competition intensifies.Medical representatives are entering an era in which they will be judged not by how many physicians they meet, but by how sophisticated a scientific discussion they can lead. Ultimately, the question facing MRs at this crossroads of change is one of expertise.
- InterView
- [Reporter's View] Drug pricing reform outruns certification
- by Jung, Heung-Jun Jul 15, 2026 08:49am
- The government's drug pricing reform for newly listed generic drugs is set to take effect next month without a single company having obtained a "Quasi-Innovative Pharmaceutical Company” certification.The Ministry of Health and Welfare concluded the public consultation yesterday (July 13) on proposed revisions to the ‘Criteria for Decision and Adjustment of Pharmaceutical Drugs,’ which include changes to generic drug pricing and pricing premiums. The revised rules are scheduled to take effect on August 1.Fostering a new drug development ecosystem has been one of the key objectives of Korea’s drug pricing reform. Creating a more innovation-oriented pharmaceutical industry was also identified as the foremost goal at the Health Insurance Policy Deliberation Committee (HIPDC) meeting in March.Measures introducing pricing premiums and preferential measures for “quasi-innovative” companies had also been introduced in this aspect. However, despite the nearing implementation date, not a single company has yet received the Quasi-Innovative certification, which remains a major disappointment.Some in the industry argued that implementation should be postponed several months until certification procedures for both Innovative and Quasi-Innovative Pharmaceutical Companies are completed. The government, however, is reportedly firm in its determination to proceed as scheduled.One might ask, "Why not select the target companies after first preparing the preferential drug pricing plan for quasi-innovative new companies?" However, the reality is not so simple.Although estimates differ between the government and industry, 10 to 20 pharmaceutical companies are expected to qualify as Quasi-Innovative Pharmaceutical Companies. Until they obtain certification, these companies will receive a 45% generic pricing rate. Once certified, the rate increases to 50%, with the pricing premium remaining in effect for up to four years.Under the revised pricing system, the premium is determined not by the characteristics of an individual product but by the innovative status of the company itself. In other words, whether or not a company has obtained the Quasi-Innovative certification directly determines the maximum reimbursement price its generic products can receive.Although the financial impact will vary depending on market conditions for each product, the combination of a 5 percentage-point increase in the pricing rate and a four-year premium period could have a significant effect on sales.As a result, the 10 to 20 pharmaceutical companies that may qualify for Quasi-Innovative certification will have to reconsider the timing of generic launches until certification is granted.The same applies to the few companies that would seek to receive the Innovative Pharmaceutical Company certification in December. Because newly certified Innovative Pharmaceutical Companies become eligible for a 60% pricing premium for four years, some companies may decide to postpone generic reimbursement listings for approximately five months until certification is complete.The government may argue that companies should simply decide their launch timing based on their own economic interests.The government may say that companies should decide the timing of generic drug launches based on their own economic interests. However, that is hardly the right approach when the pricing reform itself is meant to initiate gradual change across the pharmaceutical industry.That objective necessarily requires consideration of how well the reforms can be accepted and implemented by the industry. From that perspective, it is regrettable that the government is moving ahead with the pricing reform before adequate preparations have been completed.
- InterView
- [Desk’s View] OS still reigns supreme in reimb review
- by Eo, Yun-Ho Jul 13, 2026 09:28am
- Overall survival (OS) continued to reign supreme. Two CDK4/6 inhibitors were reviewed at the same Cancer Drug Deliberation Committee (CDDC) meeting, yet they received very different outcomes. Verzenio, backed by OS data, passed reimbursement review, while Kisqali, which has yet to demonstrate mature OS data, failed to secure reimbursement criteria.“No OS data, no CDDC approval” has effectively become an unwritten rule, especially in solid tumors. The debate over whether to recognize a class effect or uphold the primacy of overall survival (OS) ultimately appeared to end in favor of preserving OS as the decisive standard. Although the Ministry of Health and Welfare (MOHW) and the Health Insurance Review and Assessment Service (HIRA) continue to state that their decisions are based on a comprehensive assessment of clinical benefit, societal need, and budget impact, an analysis of the CDDC outcomes over the past three years suggests otherwise.The latest decision also raises another important question. Unlike Verzenio, Kisqali sought reimbursement not only for node-positive patients but also for high-risk node-negative (N0) patients, making the outcome worthy of further discussion.In early breast cancer, lymph node metastasis has long been regarded as one of the most important prognostic factors. However, the latest treatment paradigms no longer assess recurrence risk based solely on nodal status. The current standards evaluate multiple pathological risk factors, including tumor size (T stage), histologic grade, and the Ki-67 proliferation index, to determine an individual's risk of recurrence.Indeed, some patients with high-risk N0 disease are known to have recurrence risks comparable to those of N1 patients with 1-3 positive lymph nodes. In other words, the absence of lymph node metastasis does not necessarily indicate a low risk of recurrence.This change is already being reflected in major clinical trials. The NATALEE study evaluated adjuvant Kisqali therapy not only in node-positive patients but also in high-risk N0 patients, illustrating the shift in early breast cancer treatment from staging-based decisions toward more individualized and sophisticated assessments of recurrence risk.Of course, OS will remain an important standard in the decision-making process. Long-term follow-up from adjuvant studies in early breast cancer continues to produce increasingly mature survival data. However, the objective of adjuvant therapy is not simply to prolong overall survival. It also aims to reduce recurrence, prevent distant metastasis, and keep patients from progressing to advanced breast cancer.In this regard, the CDDC decision extends beyond reimbursement for a single drug and once again highlights the issue of treatment access for high-risk N0 patients. Because adjuvant therapy inherently requires longer follow-up to generate mature OS data, patients at high risk of recurrence may also face prolonged delays in accessing potentially beneficial treatment.The European Society for Medical Oncology's Magnitude of Clinical Benefit Scale version 2.0 (ESMO-MCBS v2.0) allows improvements in disease-free survival (DFS) to be considered clinically meaningful in the adjuvant setting even before mature OS data become available. This does not diminish the importance of OS; rather, it acknowledges that preventing recurrence is itself a meaningful therapeutic benefit for patients.The CDDC therefore continues to face an important challenge. While OS remains a critical source of evidence, can it alone fully capture a therapy's clinical value? Given that DFS is already recognized as a meaningful measure of clinical benefit in major assessment frameworks for adjuvant therapy, it is worth considering whether restricting patient access until mature long-term OS data become available truly represents the best policy decision.When it takes years for OS data to mature, can patients afford to wait, and can we be certain that letting them wait is really the right answer?
