- LOGIN
- MemberShip
- 2026-04-21 06:21:31
- Policy
- Study to improve ICER threshold underway
- by Jung, Heung-Jun Apr 02, 2026 08:46am
- With the government announcing plans to raise the ICER threshold next year, detailed reform measures are expected to be prepared by October this year.For this, research aimed at ensuring fiscal sustainability while realigning cost-effectiveness evaluation criteria to become more realistic will be conducted over approximately 6 months.On the 31st, the Health Insurance Review and Assessment Service (HIRA) issued a request for proposal for a research project titled “Establishing rational cost-effectiveness evaluation criteria for listing new drugs under the national health insurance system.”This study was launched in response to criticism that the current ICER threshold fails to reflect ▲rising national income and inflation ▲demands for enhanced patient coverage ▲trends in innovative drug development.Through this research, a model for calculating the ICER threshold that incorporates socioeconomic factors such as income and inflation will be developed. A weighting system that takes disease severity, therapeutic benefits, and fiscal impact into account will also be designed.The study will also explore ways to systematize and categorize ICER thresholds and develop models for applying evaluation criteria to reimbursement decisions through pilot implementation.Additionally, the government will review the introduction of a system for periodically adjusting ICER thresholds by referencing major countries. It also plans to gather input from stakeholders, including the pharmaceutical industry, patient groups, and academia.HIRA plans to sign the research service agreement between March and April, conduct an interim review, and complete the study by October. The total budget for the project is KRW 60 million.Through this study, the agency expects to establish rational cost-effectiveness evaluation criteria, thereby improving patient access to treatment and incentivizing new drug development. It also aims to build trust among pharmaceutical companies, patients, and the government by establishing clear standards and procedures.Previously, the Ministry of Health and Welfare announced plans to raise the ICER threshold next year through reforms to the drug pricing system. It decided to introduce a weighting system to allow for the flexible application of ICER values. The ministry plans to conduct policy research this year and implement a rational plan in 2027 based on the results.The government is expected to finalize detailed implementation plans based on the research results, which are due around October, and proceed with full-scale adjustments to the ICER threshold sometime next year.
- InterView
- [Reporter's View] Cut drug prices, expand R&D…SMEs 'exit pressure'
- by Choi Da Eun Apr 02, 2026 08:46am
- The government's recently announced "Drug Pricing System Improvement Plan" appears adequate in terms of its direction. The intent is to improve the market structure, which is currently centered on generics, to provide incentives for pharmaceutical companies to invest in R&D, and to promote self-sufficiency in raw materials. Furthermore, shifting the industrial constitution away from the simple, repetitive manufacturing of off-patent drugs is agreeable.However, the general opinion from the clinical settings is different. There is significant concern that the policy's incentives may actually act as a double burden for many pharmaceutical companies.The core value of this reform is a structure that guarantees relatively higher drug prices for companies with a high R&D investment ratio, in exchange for lower generic drug prices. The higher the ratio of R&D relative to sales, the more a company's generic prices are recognized, which directly correlates to corporate profitability.The problem is that this structure does not operate identically for all companies. While it may serve as a reward for top-tier pharmaceutical companies that have already secured a certain level of R&D capability and capital, it is highly likely to act as a barrier to entry for small and medium-sized enterprises (SMEs).This is because revenue is shrinking as the generic price calculation rate is lowered from 53.55% to 45%, and the timing of "tiered price reductions" for follow-on products applies to the 13th entry. If these tiered price cuts are applied to existing listed products as well, it will be difficult for many SMEs to avoid an immediate drop in cash flow.Of course, the government explains that it will provide incentives through 'Innovative' and 'New Innovative' pharmaceutical company designations. The plan is to guarantee drug prices at a maximum level of 60% for companies with high R&D ratios and apply preferential additions even to companies with a certain level of investment.However, pre-investment is required to meet these standards. A structure where one must increase R&D investment to receive benefits while revenues are decreasing is likely to become a selective incentive that is difficult for companies lacking financial flexibility to access.While the prices of generics, the immediate main source of revenue, are being cut, companies must conversely raise their R&D proportions, which requires pouring tens or hundreds of billions of won, to preserve their lowered profitability. It is a structure where companies are forced into natural extinction in the market if they fail to win the title of a 'New Innovative pharmaceutical company.'A bigger issue is that such a structure could deepen industrial polarization. While top-tier pharmaceutical companies with capital power maximize benefits by expanding R&D investment, SMEs may be pushed out of the market due to limited investment capacity.The government has stated that it will save approximately KRW 2.4 trillion in health insurance costs over the next 11 years through this move, but the price could be the collapse of the ecosystem for smaller pharmaceutical companies that have not yet built up R&D capacity. Some critics argue that this drug pricing reform is essentially a forced restructuring of the domestic pharmaceutical industry.One industry official stated, "While we agree with the direction, the current structure only allows companies with existing capacity to grow further," adding, "Unless realistic support measures that allow SMEs to participate in R&D are implemented as well, the policy effects will inevitably be limited."Pharmaceutical R&D is a long-distance race. It is difficult to evaluate based on short-term results, and the fruits only appear after investing enormous time and effort. In that sense, this drug pricing reform is like placing companies with different levels of physical fitness on the same track from the starting line and demanding they run faster.Furthermore, R&D investment carries the possibility of failure. It is not easy for a company with a weakened profit base to continue bold investments in an area where performance relative to investment is not guaranteed. Consequently, some companies may be driven to focus on securing short-term profits rather than on R&D, or even to downsize their businesses altogether for survival.There is no disagreement with the direction of reducing the overabundance of generics and advancing the industrial structure. However, speed and method are the problem. An approach that induces structural shift solely through uniform price cuts and selective incentives may result in side effects.Unless an environment is established where SMEs can gradually build R&D capabilities while maintaining a minimum investment capacity, this reform is likely to result in industrial contraction rather than promoting innovation. Ultimately, additional incentives must be planned so that policies aimed at lowering drug prices and increasing R&D do not contradict.
- Company
- Imfinzi shifts gastric cancer treatment paradigm
- by Son, Hyung Min Apr 02, 2026 08:46am
- With ‘Imfinzi’ receiving approval as a perioperative treatment for gastric cancer, there are signs that the immunotherapy-plus-chemotherapy strategy, which has long been established as the standard of care overseas, is set to gain full-scale traction in Korea as well.On March 31, AstraZeneca Korea held a press conference at the Four Seasons Hotel in Seoul to share the significance of the expanded indication for Imfinzi (durvalumab) in gastric cancer and its clinical data.On the 23rd, Imfinzi was approved as a perioperative treatment for patients with resectable gastric or gastroesophageal junction adenocarcinoma. The regimen involves combination therapy with FLOT chemotherapy (5-fluorouracil, leucovorin, oxaliplatin, and docetaxel) before surgery, followed by Imfinzi monotherapy as maintenance after surgery.Do-Youn Oh, Professor of Hematology and Oncology at Seoul National University HospitalWith this approval, Imfinzi has become the first immuno-oncology drug approved in Korea for use in the perioperative treatment setting for gastric cancer.Due to advanced screening systems and surgical techniques, the 5-year survival rate for gastric cancer patients in East Asia has been in the 75–80% range with postoperative adjuvant chemotherapy alone.However, approximately 30–40% of stage III patients still experience recurrence, indicating persistent unmet needs.Against this backdrop, perioperative treatment strategies involving chemotherapy before and after surgery have emerged as an alternative.The goal of perioperative therapy is to eliminate micrometastases early and continuously suppress systemic disease thereafter.In the U.S. and Europe, FLOT-based perioperative treatment has already become the standard. The addition of Imfinzi to this regimen has demonstrated significant clinical efficacy, supporting a shift in treatment patterns.Do-Youn Oh, Professor of Hematology and Oncology at Seoul National University Hospital, said, “Perioperative strategies to improve resection rates are already standard overseas. The clinical benefits of combining immunotherapy with chemotherapy are clear.”The Phase III MATTERHORN study was the basis for Imfinzi’s expanded indication. The trial was conducted on patients with stage II-III advanced gastric cancer who were candidates for curative surgery. While stage I gastric cancer has a high cure rate with surgery alone, stages II–III represent locally advanced disease with a higher risk of recurrence.In this study, Imfinzi-based perioperative therapy showed a statistically significant improvement in overall survival (OS).The efficacy of Imfinzi was consistently observed in Asian patients as well.In an Asian subgroup analysis presented at ESMO Asia 2025, the Imfinzi plus FLOT combination demonstrated improvements in event-free survival (EFS), 3-year OS, and pathological complete response (pCR) compared to placebo plus FLOT.At 24 months, the EFS rate was 72.1% in the Imfinzi group versus 64.2% in the placebo group. Median EFS was not reached in either group, suggesting potential widening of the gap with longer follow-up. OS also showed a similar improvement trend to that observed in global studies.The improvement in pCR was particularly notable. In the Asian patient population, the pCR rate in the Imfinzi combination group was 18.9%, more than three times higher than the 5.6% in the placebo group.Safety was also confirmed to be manageable compared to standard FLOT therapy. There were no significant differences between the two groups in Grade 3 or higher adverse events or treatment discontinuation rates, indicating that new safety concerns arising from the addition of an immunotherapy were limited.On the 31st, AstraZeneca Korea held a press conference at the Four Seasons Hotel Seoul to explain changes in treatment strategies following the expansion of Imfinzi’s indication for gastric cancer.Despite surgery remaining the cornerstone of gastric cancer treatment, there is growing recognition that surgery alone may not be sufficient for a cure. The MATTERHORN study suggests that combining immunotherapy and chemotherapy before surgery, followed by surgery and maintenance therapy, can improve long-term outcomes.Professor Oh emphasized, “The proportion of patients completing postoperative Imfinzi adjuvant therapy was around 50%, which exceeded expectations. For patient groups at high risk of micrometastasis, it is important to determine treatment strategies by comprehensively considering various factors such as extensive lymph node involvement, T4 stage, and aggressive histological subtype.”She added, “Clear criteria for determining which patients should undergo surgery first or receive neoadjuvant chemotherapy have not yet been established. Further discussion and accumulation of evidence are necessary to establish treatment strategies tailored to patient characteristics.”
- Policy
- Hair loss drug finasteride, sexual dysfunction-linked suicidal ideation warning
- by Lee, Tak-Sun Apr 02, 2026 08:46am
- AI-generated imageThe labeling for finasteride 1mg tablets, used in the treatment of hair loss, will now include warnings regarding sexual dysfunction side effects.For dutasteride, another hair loss treatment, a new "General Precautions" section will be added to include information on conditions such as depression.The Ministry of Food and Drug Safety (MFDS) recently announced that it has prepared these proposed label changes based on European Medicines Agency (EMA)'s results of a safety information review and has requested feedback from companies by the 10th.According to the revised labeling, a new statement will be added to the warnings section for finasteride 1mg tablets as "Sexual dysfunction that may affect mood changes, including suicidal ideation, has been reported in some patients. Patients should be advised to seek medical consultation if sexual dysfunction occurs. Consideration should be given to whether treatment should be discontinued."While the existing warnings section already mentioned reports of depression, it did not include specific details such as suicidal ideation resulting from sexual dysfunction, as specified in the newly added text.For dutasteride formulations, information regarding 'mood changes and depression' was added to the "General Precautions" section, which is a lower-tier alert than a warning.The newly added information states: "Mood changes (including depressed mood, depression, and rarely, suicidal ideation) have been reported in patients treated with other oral 5-alpha reductase inhibitors. Patients should be advised to seek medical consultation if such symptoms occur."For finasteride 1mg tablets, sexual dysfunction-related adverse events such as decreased libido and erectile dysfunction have already been frequently reported. They are specified in the "Adverse Reactions" section of the labeling. However, details regarding suicidal ideation linked to sexual dysfunction were previously absent.The target products for this label change include 94 items of finasteride 1mg, including the original drug Propecia 1mg.Additionally, for dutasteride, 98 items are subjected to changes, including the original drug Avodart Soft Cap 0.5mg.Meanwhile, in May of last year, the EMA specified suicidal ideation as a new adverse effect in the product information for finasteride. The EMA stated, "Cases have been included where patients complained of suicidal ideation alongside sexual dysfunction such as depression, decreased libido, and erectile dysfunction."The EMA recommended adding a warning statement regarding mood changes and suicidal ideation to dutasteride, a 5-alpha reductase inhibitor of the same class, as a precautionary measure. The EMA stated that, for dutasteride, the evidence does not currently provide a clear causal relationship, unlike that of finasteride.
- Company
- Oral CSU drug ‘Rhapsido’ nears approval in KOR
- by Eo, Yun-Ho Apr 02, 2026 08:46am
- The oral urticaria drug ‘Rhapsido’ is nearing commercialization in Korea.According to industry sources, Novartis Korea’s oral BTK inhibitor Rhapsido (remibrutinib) is expected to receive marketing authorization from the Ministry of Food and Drug Safety next month (May).Rhapsido is an oral targeted therapy that inhibits Bruton’s tyrosine kinase (BTK), a key pathway in the pathophysiology of CSU, thereby blocking the release of histamine and inflammatory mediators.The drug was approved in the United States last September for the treatment of adult CSU patients whose symptoms persist despite second-generation H1 antihistamines.CSU is a disease characterized by severe symptoms and unpredictable exacerbations, making diagnosis and management difficult. It is known to arise from immune dysregulation. In CSU patients, the immune system can be activated via allergic (IgE) or autoimmune (IgG) pathways.This leads to specific immune cells activating the BTK protein. Once activated, BTK triggers the release of histamine and other pro-inflammatory mediators, causing red, swollen, and itchy hives.The most notable feature of Rhapsido is that it is an oral drug (taken twice daily). Until now, treatment options for patients unresponsive to first-line antihistamines have been largely limited to the injectable biologic Xolair (omalizumab). The arrival of Rapsido opens a new option, an oral targeted therapy.The drug demonstrated efficacy in the Phase III REMIX-1 and REMIX-2 studies. Results showed Rhapsido demonstrated superiority over placebo in improving itch severity (ISS7), hive severity (HSS7), and total urticaria activity score (UAS7) starting from Week 2. Approximately one-third of patients achieved complete remission (defined as zero itch and zero hives) by Week 12.Beyond CSU, Novartis is also expanding clinical development of Rhapsido across a range of immune-mediated diseases, including chronic inducible urticaria (CIndU), hidradenitis suppurativa (HS), food allergy, and multiple sclerosis.
- Company
- Lilly Korea sales, 194%↑ from a year earlier…'Mounjaro' effect
- by Son, Hyung Min Apr 02, 2026 08:46am
- Eli Lilly Korea's sales structure in South Korea is undergoing a rapid, substantial changes. Following the launch of the GLP-1 class blockbuster 'Mounjaro,' the company’s financial performance has surged, completely restructuring its growth model, which previously centered on its core products.According to the Financial Supervisory Service, Eli Lilly Korea’s sales last year reached KRW 482.1 billion, a 193.6% increase compared to the previous year. During the same period, operating profit rose by 259.2%, jumping from KRW 10.3 billion in 2024 to KRW 37.1 billion last year. Eli Lilly Korea's sales performance by year (unit: KRW 100 million)Previously, the company's sales relied on oncology drugs such as ‘Verzenio (abemaciclib)’ and ‘Cyramza (ramucirumab),’ as well as the SGLT-2 inhibitor ‘Jardiance (empagliflozin)’ and the biologic ‘Taltz (ixekizumab).’ Due to a lack of new blockbuster entries, sales had stalled below KRW 200 billion from 2021 to 2024.However, this structure changed abruptly with the emergence of ‘Mounjaro (tirzepatide).’ Mounjaro secured outstanding growth momentum by rapidly expanding beyond diabetes into the obesity treatment market.Mounjaro acts on both the glucose-dependent insulinotropic polypeptide (GIP) receptor and the glucagon-like peptide-1 (GLP-1) receptor. Through this dual action, it stimulates insulin secretion, improves insulin resistance, and decreases glucagon secretion, thereby lowering both fasting and postprandial blood glucose levels.In patients with diabetes and obesity, the "incretin effect" is typically diminished, primarily due to reduced GLP-1 secretion and impaired GIP action. As GLP-1 and GIP are key hormones responsible for approximately two-thirds of the postprandial insulin response, the dual-axis mechanism of Mounjaro stands out as a significant clinical advantage.Mounjaro's first indication was secured in June 2023 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. In August 2024, the indication was expanded for chronic weight management. By expanding its scope to include patients with obesity or overweight patients with weight-related comorbidities, Mounjaro successfully became positioned as an obesity treatment.Released in the domestic market last August, Mounjaro quickly secured position in the market. According to market research firm IQVIA, Mounjaro recorded KRW 28.4 billion in sales in Q3 of last year, which then surged to KRW 187.1 billion in Q4, easily surpassing KRW 100 billion in quarterly sales for a single item. During the same period, it outpaced its competitor 'Wegovy (semaglutide),' rapidly increasing its market dominance.A similar trend is observed in the global market. As of Q2 of last year, Mounjaro's global sales exceeded those of Wegovy, marking a significant turning point in the battle for leadership in the obesity treatment market.Active Development of Multi-Mechanism GLP-1 SuccessorsLilly is also continuously strengthening its GLP-1-based portfolio. Currently, the oral GLP-1 agonist 'orforglipron' is undergoing regulatory approval processes in more than 40 countries, with a New Drug Application (NDA) for type 2 diabetes expected in the U.S. by the end of this year.Unlike Mounjaro, orforglipron is a single GLP-1 mechanism but distinguishes itself as an oral medication. Notably, it does not require fasting after administration and, as a small-molecule-based drug, has lower production costs, suggesting high market scalability. In clinical trials, it has shown superior results compared to competitors in both HbA1c reduction and weight loss.Lilly's diabetes and obesity treatment 'Mounjaro'Next-generation pipelines are also under development. For instance, 'retatrutide,' a triple agonist that simultaneously targets GLP-1, GIP, and glucagon (GCG). Currently, no triple-action obesity drug has been approved, and retatrutide, which is in Phase 3 clinical trials, is considered the closest to commercialization.According to recently released Phase 3 study results, retatrutide met primary endpoints by demonstrating significant improvements in HbA1c and weight loss compared with placebo. Lilly is considering strategies to expand retatrutide's indications beyond obesity to various chronic diseases, including diabetes and liver disease.Additionally, 'eloralintide,' which targets both GLP-1 and amylin receptors, has entered global Phase 3 trials. This drug mimics the action of the amylin hormone secreted by the pancreas to act directly on the brain, thereby increasing satiety and suppressing food intake.
- Company
- Global pharmas cautiously welcome pricing reform
- by Son, Hyung Min Apr 01, 2026 08:15am
- “Domestic firms are crying, multinational firms are smiling.” This is the prevailing assessment of Korea’s latest drug pricing reform.With the reform centered on lowering prices of generic drugs now finalized, Korea’s drug pricing structure is approaching a turning point. While the government has proposed reallocating savings toward rewarding innovative drugs and improving patient access, the industry is also voicing cautious views that outcomes will depend on the system’s effectiveness and execution.According to industry sources, the Ministry of Health and Welfare finalized the drug pricing reform plan on the 26th through the Health Insurance Policy Deliberation Committee (HIPDC). The reform focuses on lowering the pricing benchmark for generic and off-patent drugs from the current 53.55% to around 45%.This reform is regarded as significant not simply as a price cut, but as a structural reorganization aimed at strengthening incentives for innovative drugs using the savings generated.The key lies in resource reallocation. The strategy is to use the funds secured by adjusting the generic-centric pricing structure to lower barriers to reimbursement for new drugs through measures such as ▲faster reimbursement listing of treatments for rare and severe diseases, ▲introduction of flexible drug pricing contracts, and ▲raising the ICER (incremental cost-effectiveness ratio) threshold.This is interpreted as a response to long-standing criticism that Korea’s pricing system has focused excessively on cost containment, limiting access to innovative therapies.The Ministry of Health and Welfare also defined the reform as a structural transformation of the pricing system.The Ministry stated, “By advancing the drug pricing system to the level of major countries, we can enhance public access to treatment and coverage while r reducing drug expenditure burdens. Establishing a compensation system for research and development and efforts to ensure the stable supply of essential medicines will serve as a momentum for the pharmaceutical and biotech industries to take the leap forward.”Global pharmas express “cautious optimism”…System design is keyGlobal pharmaceutical companies are generally welcoming the reform. Given that patient access and reimbursement rates for new drugs in Korea have lagged behind major countries, there is an expectation that savings from generic price cuts could improve access to innovative therapies.The Korea Research-based Pharmaceutical Industry Association (KRPIA), which is primarily composed of multinational pharmaceutical companies, also offered a positive assessment.The association stated, “he policy reflects a commitment to reflecting the value of innovative new drugs and enhancing patient access. It is crucial whether the reform’s intent is actually realized through system design and implementation,” thereby emphasizing the importance of policy implementation.This expectation is also supported by data. According to PhRMA’s ‘2023 Global Access to New Medicines Report,’ among the 460 new drugs covered by health insurance worldwide from 2012 to 2021, South Korea’s coverage rate was 22%, falling below the G20 (28%) and OECD (29%) averages.For innovative cancer drugs, the rate was 23%, and for rare disease treatments, it was just 12%, both significantly lower than the G20 and OECD averages, respectively.However, global pharmaceutical companies are also expressing conditional caution. While the entry environment may improve, there are concerns that requirements for demonstrating value during reimbursement listing have become more stringent.An official from a global pharmaceutical company noted, “It is positive in terms of improving access to new drugs and strengthening clinical value-based evaluation. However, the strengthened post-listing price control raises concerns about predictability.”Another official from a global pharmaceutical company agreed with the direction but raised questions about its implementation.The official said, “The changes in government perception toward rare and severe diseases are significant. Even drugs under the pilot approval-evaluation-negotiation linkage program are facing reimbursement delays, so concrete execution plans are urgently needed.”Regarding the increase in the ICER threshold, the official emphasized, “The magnitude of the increase is more important than the direction itself. If implementation is delayed under the pretext of policy research, it will just become another waiting period for patients.”Institutional issues surrounding global pharmaceutical companies also remain unresolved. Industry feedback regarding the revision of certification criteria for innovative pharmaceutical companies was, “only the name has changed, with limited substantive improvement.”Apart from the fact that bonus points are awarded for certain factors such as attracting foreign capital, joint research, and open innovation, the assessment is that the industry’s long-standing demand for the inclusion of achievements in attracting headquarter-level R&D investment has not been sufficiently reflected. Furthermore, the fact that indicators, such as the scale of pharmaceutical exports, which are difficult for multinational companies to meet, remain unchanged, poses disadvantages.While some companies are already expanding cooperation with the government and joint research with domestic firms with certification in mind, the extent to which these efforts will be reflected in evaluations remains uncertain.An industry official stated, “To foster the domestic biotech ecosystem, collaboration with global pharma is essential. Since the role of domestic branches is crucial in attracting headquarter-level R&D investment, these characteristics need to be reflected in the design of the system.”Another industry official noted, “The new system is already affecting future pipeline processes. Multinational companies have been strengthening preparations to obtain the Innovative Pharmaceutical Company certification,” suggesting that this reform is bringing about changes in actual business strategies in practice.
- Policy
- Daewon Pharm joins the Prolia biosimilar competition
- by Lee, Tak-Sun Apr 01, 2026 08:15am
- AI-generated image (Prolia, Stoboclo, Obodence, Izambia, Junod)A series of biosimilars with the same active ingredient as Amgen’s osteoporosis drug Prolia are being approved. With Daewon Pharm joining the race, 5 products have now received marketing authorization in Korea.Prolia is an osteoporosis treatment administered as a subcutaneous injection once every 6 months, offering strong bone density improvement and fracture prevention effects.In Korea, it has dominated the market with annual sales of approximately KRW 180 billion through copromotion with Chong Kun Dang.On the 31st, the Ministry of Food and Drug Safety approved Daewon Pharma’s Prolia biosimilar, ‘Junod Prefilled Syringe.’This product is indicated for: ▲ the treatment of postmenopausal women with osteoporosis, ▲ the treatment of men with osteoporosis to increase bone density, ▲ the treatment of glucocorticoid-induced osteoporosis, ▲ the treatment of bone loss in patients with non-metastatic prostate cancer receiving androgen deprivation therapy, and ▲ the treatment of bone loss in women with breast cancer receiving adjuvant aromatase inhibitor therapy.It is administered via subcutaneous injection 6 six months in the upper arm, upper thigh, or abdomen, identical to Amgen’s Prolia. The product demonstrated equivalence to Prolia through Phase I and Phase III trials.Juno is a biosimilar developed by Gedeon Richter, headquartered in Budapest, Hungary.Gedeon Richter is a multinational pharmaceutical company with a global presence.In addition to Junod, Daewon Pharm has also introduced the Forteo biosimilar ‘Terrosa Inj’ through an agreement with Gedeon Richter. Terrosa was developed by Richter-Helm Biotec, a joint venture between Gedeon Richter and the German company Helm.With Daewon Pharm obtaining approval for Junod, there are now 5 Prolia biosimilars available in the Korean market.Celltrion’s ‘Stoboclo Prefilled Syringe’ was the first biosimilar approved in November 2024, followed by Samsung Bioepis’ ‘Obodence Prefilled Syringe,’ Meditip’s ‘Meditip Denosumab Prefilled Syringe,’ and HK inno.N’s ‘Izambia Prefilled Syringe,’ all of which have obtained marketing approval.Meditip Denosumab Prefilled Syringe was approved in Korea through a regulatory affairs agency, and Novartis has been identified as the contract manufacturer. There is a possibility that Novartis will handle domestic sales in the future.HK inno.N’s Izambia was developed by Spain-based mAbxience. HK inno.N has also signed a contract with mAbxience to introduce a nivolumab (brand name: Opdivo) biosimilar in addition to this denosumab biosimilar.Meanwhile, Celltrion’s Stoboclo is being co-marketed by Daewoong Pharmaceutical, and Samba’s Obodence is being co-marketed by Hanmi Pharmaceutical.The denosumab biosimilar market is rapidly becoming a battleground among major domestic pharmaceutical companies.Currently, Celltrion’s Stoboclo and Samsung Bioepis’ Obodence are listed for reimbursement. Full-scale competition is expected once the remaining approved products are also listed. All patents for Prolia listed with the MFDS expired as of March 17 last year.
- InterView
- [Reporter's View] Let's focus on building 'solid pharmas'
- by Lee, Jeong-Hwan Apr 01, 2026 08:15am
- Why does the conflict between the Ministry of Health and Welfare (MOHW) and the pharmaceutical industry over drug pricing reforms repeat the same patterns? The MOHW finalized a reform plan at the Health Insurance Policy Review Committee, held in March, focusing on reducing generic drug prices while providing incentives for innovative pharmaceutical companies and those contributing to the supply of unstable essential medicines. However, the differences in position between the two parties do not seem to be clearly resolved.The MOHW promised to exchange information and gather opinions to design a reform plan that could also be favorable to the pharmaceutical industry, addressing the National Assembly, the media, and the industry. However, the prevailing assessment is that these efforts remained insufficient and incomplete.Of course, it is impossible to devise an administration or policy that satisfies everyone 100%. The MOHW's stance during deliberations on this drug-pricing reform was unsatisfactory.The MOHW's challenge is understandable. Lee Hyung-hoon, the 2nd Vice Minister of Health and Welfare and Chairman of the Health Insurance Policy Review Committee, expressed the hardship during the process of establishing the reform plan. Lee noted that it is not easy to achieve both the conflicting tasks of ensuring health insurance efficiency and fostering the pharmaceutical industry. Lee's sincere statement received positive responses from reporters, offering a chance to experience and empathize with the difficulties of operating executive branch policy.Despite this, the MOHW must seek better ways to engage the pharmaceutical industry when devising future drug pricing reforms. This is to minimize the aftereffects of exhaustive clashes between the government and industry, while improving the likelihood of a soft policy landing.Health economists point out that the MOHW has not made sufficient effort to design a drug-pricing system that balances equity between the domestic and multinational, foreign-capital pharmaceutical industries.Furthermore, they note that it is difficult to discern the MOHW's philosophy and specific direction for managing National Health Insurance finances. They stated that the administrative goals are so blunt and ambiguous that it is difficult to predict them. The criticism is that if the MOHW were to reveal its inner thoughts transparently, proper consultation would be possible.The MOHW emphasized the "structural improvement toward innovative new drugs" as the justification for this drug pricing reform and as a mechanism to appeal that it is inevitable to cut the prices of already-listed generics.While the direction might not be wrong, the slope was too steep. South Korea's pharmaceutical industry is still centered on generics. The quality and self-sufficiency rate of generics are high. In reality, hundreds of items are licensed, prescribed, and distributed for a single active ingredient.On the other hand, only 41 domestically developed new drugs have obtained marketing authorization. The first domestically developed new drug was Sunpla (SK Pharma), authorized in July 1999, and the most recent domestic new drug is Xcopri (Dong-A ST), which received its license in November 2025, making it the 41st. Among these, no new drug has achieved blockbuster-level sales.To demand that the domestic pharmaceutical industry, which has birthed 41 new drugs over 25 years and is still evaluated as being at a "high school level" or a "twenty-year-old" who has just removed the label of a minor, instantly stop manufacturing and selling generics to produce blockbuster results is an excessively harsh demand.The reform plan should have reflected more of the industry's concerns about how much new drug Research and Development (R&D) will be revitalized by this drug pricing reform, how negative it will be for the supply of price-stabilized medicines, and the potential causal link to employment stability.In MOHW data on the direction of drug pricing reform, one word stood out: "solid pharmaceutical companies."The MOHW expressed its ambition to use this reform as a turning point to cultivate and support robust pharmaceutical companies that are sincere about new drug development and the stable supply of essential medicines, rather than being buried only in generic sales competition.To achieve this ambition, the MOHW must set transparent, clear standards for what constitutes a "solid pharmaceutical company" and develop evaluation indicators. A process involving a public-private consultative body is necessary. This means that active administration and two-way communication are absolutely required to align the "zero point" regarding "robustness" with pharmaceutical companies.During the process of establishing drug pricing reform plan, many "solid" pharmaceutical companies that have secured R&D ratios criticized the government, saying, "It is doubtful whether the MOHW or the MFDS has the standards to distinguish innovative pharmaceutical companies that are sincere about industrial development and public health, or if they even have the evaluation data."The point was that government administration capable of distinguishing "paper companies" that rely on consigned generic production as their core revenue source from "real" pharmaceutical companies has not been properly carried out until now.In a situation where there is zero trust in whether the government has the criteria to distinguish the wheat from the chaff or the administrative power to do so, the MOHW suddenly pushed a reform plan to cut generic prices by up to 40% while favoring companies that have proven innovation. The industry voiced that they were told to just "sign it," which led to frustration and even fear.When promoting the reform plan, the MOHW must conduct follow-up oversight to develop a comprehensive report card that clearly distinguishes robust pharmaceutical companies and provides tailored support.The MOHW now faces the difficult task of communicating closely with the pharmaceutical industry to find and resolve the blind spots in government administration regarding the resolution of the multi-item generic structure, while recognizing that high-quality generics are the heart of K-Pharmaceuticals and the "two legs" that will support the future of industry and employment.We anticipate MOHW administration that identifies field-level clues to fundamentally shift the policy paradigm away from simply cutting generic prices. This would be catching two birds with one stone: health insurance cost savings and new drug development.
- Company
- NMOSD drug ‘Uplizna’ fails reimbursement again in KOR
- by Eo, Yun-Ho Apr 01, 2026 08:15am
- Uplizna, a new drug for neuromyelitis optica spectrum disorder (NMOSD), has failed to secure reimbursement listing in its second attempt.According to Dailypharm coverage, Mitsubishi Tanabe Pharma Korea’s pricing negotiations with the National Health Insurance Service (NHIS) for Uplizna (inebilizumab), a treatment used to treat adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-Aquaporin-4 (AQP4) antibodies, have ultimately collapsed.Although both sides made efforts to continue discussions by extending the negotiation period, it is understood that disagreements arose over adjustments to the expenditure cap.Consequently, it is expected that Uplizna, which had been gaining expectation as a new treatment option for NMOSD, will face significant challenges in establishing a practical prescription environment in the domestic market for the time being.Uplizna had also previously halted its listing process last October at the pricing negotiation stage due to supply-related issues.At the time, the company had accepted the “below the evaluated amount” condition set by the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee and entered price negotiations. However, the parties failed to reach an agreement within the 60-day negotiation period. Subsequently, HIRA attempted to enter into extended negotiations, but the talks could not begin as the pharmaceutical company was unable to ensure domestic supply.Supply-related issues for Uplizna remain unresolved. The drug was originally developed by Amgen, while Tanabe holds commercialization rights for Korea and other Asian countries through a licensing agreement.It remains to be seen what steps Uplizna will take next after failing its second attempt to secure reimbursement coverage in Korea.NMOSD occurs when AQP4 autoantibodies, a disease-specific biomarker produced by B cells, bind to AQP4, a target antigen present on glial cells in the central nervous system, and activate the immune responses, causing nerve damage.Uplizna is an anti-CD19 human monoclonal antibody that selectively binds to CD19, a B-cell-specific surface antigen, depleting B cells that produce AQP4 antibodies, thereby preventing disease relapse.The safety and efficacy of Uplizna were demonstrated in the N-MOmentum study, which evaluated the use of Uplizna monthly in 230 patients without the use of concomitant immunosuppressive agents.Study results showed that 89% of patients treated with Uplizna did not experience a relapse during 197 days of follow-up, resulting in a 77.3% reduction in the risk of relapse compared to placebo. Safety evaluations of Uplizna also showed comparable rates of adverse events to the placebo group.
