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- 2026-04-04 13:44:20
- Company
- ‘No intention to manufacture APIs despite incentives’
- by Kim, Jin-Gu Jan 08, 2026 07:31am
- The pharmaceutical industry has assessed that the “supply-stability incentive” system, which is included in the government’s drug pricing reform plan, lacks sufficient appeal to drive actual production expansion.Seven out of ten CEOs of pharmaceutical and biotech companies responded that even if the premium is applied, they have no intention of engaging in active pharmaceutical ingredient (API) production or the manufacture of nationally essential medicines. Industry leaders pointed out that the incentive level is insufficient to offset rising costs and risks, becoming a temporary measure rather than a structural solution.7 in 10 CEOs: “Supply-stability incentive ineffective; no intention to expand production”On the 7th, the ‘Emergency Countermeasure Committee for Pharmaceutical Price System Reform to Promote the Development of the Pharmaceutical and Bio Industry’ (Emergency Committee) released the results of an urgent survey conducted among CEOs of pharmaceutical and biotech companies. Fifty-nine pharmaceutical and biotech companies participated in this survey.When asked if they were willing to produce APIs themselves to receive the ‘supply stability incentive,’ 69.5% (41 companies) responded ‘”no.”Similarly, a majority of respondents expressed reluctance to manufacture national essential medicines using domestically produced APIs, with 59.3% (35 companies) answering “no,” while only 35.6% (21 companies) said “yes.”Negative views also dominated assessments of the eligibility criteria and incentive rates associated with the supply-stability surcharge. 52.5% (31 companies) said the current framework was “not reasonable.”Key reasons cited included: ▲Surcharge levels insufficient to cover costs ▲Need for structural stability measures like permanent price cap increases rather than temporary surcharges ▲ Need to consider expanding incentives even for non-essential medicines when using domestic APIs.The Emergency Committee views that if the supply stability surcharge fails to function as a production incentive, it may also limit the policy goal of securing supply stability. The pharmaceutical industry consistently points out that the uncertainty is too high to justify additional investment solely to meet the incentive eligibility requirements.“Market-linked actual transaction pricing system may intensify non-voluntary price competition”Concerns were also raised regarding the market-linked actual transaction price system.When asked about the potential impact on corporate competition and distribution strategies if the market-linked actual transaction price system is introduced and the incentive payment rate is expanded from the current 20% to 50% (multiple responses allowed), 91.5% of respondents (54 companies) answered that “profitability will deteriorate due to intensified involuntary price competition.”Additionally, many responded that changes in sales and distribution strategies would be inevitable, such as ▲the strengthening of healthcare institutions' unilateral bargaining power due to the expanded incentive payments and ▲the increased use of CSOs.Regarding “Innovation incentives”… “Innovation incentives will decrease in practice” concerns ariseRegarding whether the innovation incentive would provide a meaningful preferential benefit, the most common response was ‘preferential treatment will actually decline’ at 49.2% (29 companies).Companies giving this response cited reasons including: ▲ Not qualifying for innovation criteria, ▲ Benefits dropping to the 40% range after the incentive period ends, resulting in minimal benefit, ▲ Narrowing of eligibility from the previous 68% incentive group to only the top 30% of companies by R&D spending ratio, ▲ Incentives being temporary, with benefits immediately reduced if R&D investment levels change.Regarding the validity of the ‘classification criteria and validity of the innovation preferential rate,’ 72.9% (43 companies) answered “not valid.’Reasons cited included: ▲unreasonable differential application of incentives ▲need to judge innovation criteria based not only on R&D spending ratio but also on the quality of overall research outcomes (e.g., new drug pipelines).As for improvements needed in the current Innovative Pharmaceutical Company designation criteria, respondents suggested including facility investment, venture investment, number of clinical trials, technology transfers, and patent registrations in the calculation of R&D expenditures.Additionally, regarding the appropriate bonus period, 32.2% (19 companies) responded ‘3+3 years’.Policy improvements: flexibility in innovation criteria, funds, and tax supportIn response to an open-ended question on additional government support measures needed beyond the current drug pricing reform to promote R&D investment and innovation across the pharmaceutical and biotech ecosystem, the most frequently cited proposal was greater flexibility in the criteria for designating innovative pharmaceutical companies (25 companies).Additionally, many companies highlighted the need for: ▲Expanding funds and R&D tax credits ▲Supporting investments in manufacturing facilities and quality control ▲Providing preferential treatment for suppliers of essential medicines and exit-prevention drugs, along with support for companies addressing supply instability.Finally, 50 companies opposed the inclusion of generic drugs in the price-volume agreement negotiations.Reasons cited included: ▲Generics already have sufficiently low prices, making further reductions double regulation ▲Expanding generic use already contributes to health insurance cost savings ▲Inconsistency with systems in major overseas countries that only apply such measures to new drugs.
- Company
- Pharmaceutical exports to Venezuela account for 0.02%
- by Kim, Jin-Gu Jan 07, 2026 08:46am
- Korea’s pharmaceutical exports to Venezuela totaled USD 1.53 million (approximately KRW 2.2 billion) last year, leading to projections that the impact of the recent U.S. military operation in Venezuela on Korean drug exports will be limited.According to the Korea Customs Service, on January 6, Korean pharmaceutical exports to Venezuela through November last year amounted to USD 1.526 million. This represents just 0.02% of Korea’s total pharmaceutical exports (USD 7.92788 billion) over the same period.Domestic pharmaceutical exports to Venezuela have fluctuated significantly over the past decade. Export volumes stood at USD 3.25 million in 2016, plummeted to USD 130,000 in 2017, rebounded sharply to USD 5.13 million in 2023, and then fell again to USD 650,000 the following year.Despite these fluctuations, Venezuela’s share of Korea’s total pharmaceutical exports has consistently remained below 0.1%. This is why the impact of the U.S. military operation in Venezuela is expected to be minimal on Korea’s pharmaceutical exports.The assessment is that the geopolitical variables affecting neighboring Latin American countries are also unlikely to have significant ripple effects. Domestic pharmaceutical companies primarily sign bundled regional contracts to supply medicines, covering multiple nearby markets like Colombia, Ecuador, and Peru, rather than exporting to Venezuela on a standalone basis. Under this structure, shortfalls in one country can often be offset by volumes in others, mitigating overall contract risk.However, given that Venezuela was mentioned as a competitive export region for domestic P-CAB class gastroesophageal reflux disease (GERD) treatments alongside neighboring Latin American countries, the possibility that it could act as a mid-to-long-term variable has been raised. Relevant companies are closely monitoring developments.HK Inno.N is aiming to expand its flagship GERD drug K-CAB into 18 Latin American countries, including Venezuela. In 2018, the company signed a finished-product export and distribution agreement with major Latin American pharmaceutical company Laboratorios Carnot, covering Mexico, Venezuela, Colombia, Peru, Chile, Ecuador, Uruguay, Paraguay, Bolivia, the Dominican Republic, Guatemala, Honduras, Nicaragua, Costa Rica, Panama, and El Salvador. Subsequently, in 2022, it added a technology transfer agreement with Eurofarma for Brazil.Onconic Therapeutics has also established a supply structure for its GERD drug Jaqbo, following a technology export agreement with Mexican pharmaceutical company Laboratorios Senosiain, covering 19 Latin American countries, including Venezuela.Daewoong Pharmaceutical is actively pursuing Latin American expansion for its P-CAB drug Fexuclue, aiming for global expansion into 100 countries. The product has already been launched in Mexico, Ecuador, and Chile, with regulatory applications submitted in Brazil and Peru. While no official entry into Venezuela has been announced, a regional strategy encompassing neighboring countries is being considered. Daewoong previously employed a bundled contract strategy with local partners for its botulinum toxin product ‘Nabota’ in Latin America. An industry official stated, “Exports of pharmaceuticals to Venezuela were already limited in scale, and the contract structure was mostly regional agreements. It seems unlikely that this situation will have a direct impact. However, considering the geopolitical risks surrounding the Latin American pharmaceutical market in the mid to long term, companies should review export routes and contract structures.”The United States launched military operations on Venezuela's capital, Caracas, and other locations in the early hours of the 3rd (local time). President Donald Trump announced via Truth Social that they had successfully captured Nicolas Maduro. Regarding the reason for the operation, President Trump stated, “Maduro committed narco-terrorism crimes against Americans, and he will face justice. The United States will govern Venezuela until the regime change, and Maduro will face U.S. judicial proceedings.”
- Policy
- ImmuneOncia, Merck, and Bayer receive orphan drug designation
- by Lee, Tak-Sun Jan 07, 2026 08:46am
- Three new drug candidates, including ImmuneOncia's lymphoma treatment candidate danverstotug, have been designated as orphan drugs in Korea.Designation as orphan drugs increases the likelihood of expedited approval through fast-track review, potentially accelerating the commercialization of these products.On January 2, the Ministry of Food and Drug Safety (MFDS) announced the designation of three new drug candidates, danverstotug, mirdametinib, sevabertinib, as orphan drugs.Danverstotug is a novel lymphoma drug candidate being commercialized by ImmuneOncia, Yuhan Corporation's immune-oncology subsidiary.As an immunotherapy targeting relapsed/refractory NK/T-cell lymphoma, it demonstrated efficacy in a domestic Phase II clinical trial, based on which the company applied for orphan drug designation to the MFDS last July.According to the company, the Phase II study in patients with relapsed or refractory NK/T-cell lymphoma who had failed first-line therapy showed an objective response rate (ORR) of 79% and a complete response (CR) rate of 63%.The median progression-free survival (PFS) was 29.4 months, while overall survival (OS) rates were 85% at one year and 78% at two years. Adverse reactions were mostly mild, and 40% of all patients completed the two years of long term treatment.The company has completed the commercial manufacturing technology transfer for this drug to Lonza, a global contract development and manufacturing organization (CDMO). ImmuneOncia aims to launch the drug before 2030.Mirdametinib is a drug used for neurofibromatosis with plexiform neurofibroma that received US FDA approval in February last year. The drug is expected to compete with Koselugo (selumetinib, AstraZeneca), an existing therapy for neurofibromatosis.Mirdametinib was developed by US-based biotech SpringWorks Therapeutics, which was acquired by Merck (Germany) in April last year for USD 3.9 billion.Bayer’s sevabertinib is an investigational therapy for HER2-positive non–small cell lung cancer, an area with limited treatment options. The drug is gaining attention as a potential alternative for patients who do not respond to existing therapies. The US FDA has granted the drug accelerated approval status and is conducting a priority review.When designated as an orphan drug, data submission required for approval is simplified, allowing exemptions from bridging studies, conditional approval, and fee reductions. It also enables a fast-track approval process through priority review. The Ministry of Food and Drug Safety (MFDS) recently relaxed the requirements for orphan drug designation, lowering regulatory barriers. Previously, data demonstrating improved efficacy over existing alternatives was required, but under the revised rules, such data are no longer mandatory for orphan drug designation.
- Company
- Rare cancer drug 'Welireg' faces another reimb hurdle
- by Eo, Yun-Ho Jan 07, 2026 08:46am
- The rare anti-cancer drug 'Welireg' has once again failed to be added to the insurance reimbursement list. This is the third round.MSD Korea submitted a reimbursement application for its Welireg (belzutifan), an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in June of last year. However, the company received a decision of 'reimbursement criteria have not been set' from the final review of the Cancer Drug Review Committee (CDRC), held at the end of 2025.This is the third report of Welireg failing to pass the CDRC review following previous failures in August 2025 and March of last year. Since its domestic approval in May 2023, the drug has remained non-reimbursed for over 2.5 years. Attention is now focused on whether Welireg will be summitted again for listing in 2026.Welireg was designated as an orphan drug in Korea in 2023 for the rare disease indication of von Hippel-Lindau (VHL) disease and received final approval in May of the same year.The specific indications include the treatment of adult patients with VHL disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), where immediate surgery is not required.Welireg works by reducing the transcription and expression of HIF-2α target genes involved in cell proliferation, angiogenesis, and tumor growth.The efficacy of Welireg was demonstrated in the open-label Study 004, which enrolled 61 patients with VHL-associated RCC who had at least one measurable solid tumor localized to the kidney.Enrolled patients also had other VHL-associated tumors, including CNS hemangioblastomas and pancreatic neuroendocrine tumors.The primary efficacy endpoint of the clinical trial was the objective response rate (ORR), measured by radiological assessment using RECIST v1.1 evaluated by an independent review committee. Additional efficacy endpoints included duration of response (DoR) and time to response (TTR).The results showed that Welireg achieved an ORR of 49% in patients with VHL-associated RCC. All responses were partial responses. The median DoR has not yet been reached, and 56% of patients had response persistence for at least 12 months. The median TTR was 8 months.Furthermore, in 24 patients with VHL-associated CNS hemangioblastomas, the ORR was 63%. Within this group, the complete response (CR) rate was 4%, and the partial response (PR) rate was 58%.
- InterView
- [Reporter’s View] High-priced drugs: efficacy vs. efficiency
- by Son, Hyung Min Jan 07, 2026 08:46am
- The launch of high-priced anticancer drugs and treatments for rare diseases will continue. There is no question that the efficacy of new drugs is improving, with a growing number of therapies extending survival or even offering the possibility of a cure.The problem lies in how, for whom, and by what criteria these treatments should be used. This question is generating considerable debate in practice.According to the collective views of oncology specialists, the current reimbursement framework is producing paradoxical outcomes.This is because drugs for cancers with large patient populations are failing to secure reimbursement approval, even when they demonstrate strong clinical efficacy, simply because of concerns over financial sustainability. More problematic than the negative reimbursement decision itself is the lack of explanation regarding the rationale and criteria behind such decisions.In the past, in addition to the improvement in overall survival (OS), the contribution of domestic patients to clinical trials was a key evaluation factor during approval or reimbursement review for new drugs. If domestic patients contributed to the clinical results, this was also partially reflected in the approval and reimbursement decision-making process.Recently, however, a clear shift has emerged. Regardless of clinical benefit, drugs targeting cancers with large patient populations tend to be disadvantaged in reimbursement discussions, while coverage is increasingly concentrated on rare cancers with smaller patient populations. This perception is widely shared among clinicians.If reimbursement policies have been adjusted due to financial constraints, the criteria and reasoning behind those decisions must be explained more clearly. Otherwise, patients are left unable to understand why the treatment they need is denied reimbursement.Clinicians are well aware that healthcare resources are limited. However, there is growing concern over whether those limited resources are truly being allocated to where they are most needed.For example, during cancer follow-up care, CT, MRI, and PET scans are often repeated without clear clinical justification. Streamlining expenditures in these areas could free up a substantial amount of funding for essential treatments.The national health screening system also warrants reconsideration. Currently, cancer patients receive the same health screening notifications as the general population, leading to redundant examinations.Despite cancer patients undergoing regular follow-up and monitoring at hospitals, the central data system fails to administratively distinguish them. Simply excluding cancer patients from routine general health screenings could significantly reduce unnecessary expenditures.The government states that the ongoing drug price reforms and reimbursement system improvements are intended to safeguard the National Health Insurance finances and ultimately save patients with cancer and rare diseases. The direction itself, aimed at improving access to new drugs, cannot be denied. However, it is clear that before restricting treatment access, citing limited resources, we must first examine whether there are areas where public funds are being wasted inefficiently.In the era of high-priced innovative medicines, reimbursement decisions are not merely about reducing or expanding reimbursement. They are about choosing between efficacy and efficiency. If patient survival and access to treatment are truly the guiding principles, then the priority should be eliminating unnecessary spending and systemic inefficiencies.
- Company
- BD Korea revenue exceeds KRW 300B…record high
- by Hwang, byoung woo Jan 06, 2026 08:25am
- In the first fiscal year following the spin-off of its diabetes business unit, BD (Becton, Dickinson and Company) Korea recorded revenue exceeding KRW 300 billion, rewriting its highest performance to date.Despite selling off a business unit that generated approximately KRW 15 billion in annual revenue, the company continued its expansion, demonstrating the success of its business reorganization through numbers. Analysts believe aggressive M&A activity and the targeting of new markets directly drove this performance.Exceeding revenue of KRW 313.5 billion…record growth gains attentionBased on an analysis of audit reports for the 43rd to 46th fiscal years, BD Korea achieved revenue of KRW 313.5 billion in the 2025 fiscal year (October 1, 2024, to September 30, 2025).This figure represents a 25.1% increase compared to the KRW 250.6 billion recorded in the previous fiscal year (October 1, 2023, to September 30, 2024).Profitability indicators, including operating profit and net income, also showed significant improvement during this period.Operating profit for 2025 reached KRW 13.8 billion, an increase of approximately 41% from the KRW 9.8 billion recorded the previous year. Net income also grew by 25.4% to 10.6 billion KRW, demonstrating the company's qualitative and quantitative growth.In particular, this growth is considered highly significant, as it was achieved after the sale of the diabetes business unit, now called Embecta Korea, in March 2024.BD, founded in the United States in 1897, maintains a broad portfolio that spans traditional medical consumables, such as syringes, to advanced diagnostics, life science research equipment, and drug delivery devices.The Korean subsidiary, BD Korea, has built a robust business structure encompassing not only the hospital and diagnostic markets but also the research and pharmaceutical industries, including flow cytometry, single-cell analysis, and drug delivery devices for biopharmaceuticals.The most direct cause of the revenue jump in 2025 is attributed to aggressive M&A.In early October 2024, BD Korea acquired the 'Advanced Patient Monitoring (APM)' business unit from Edwards Lifesciences Korea for KRW 17.6 billion.According to the audit report, BD Korea recognized approximately KRW 9.8 billion in goodwill through this acquisition. It secured KRW 7.1 billion in inventory assets, significantly strengthening its critical care and operating room solution portfolio.As the APM business unit's revenue in the 2025 fiscal year was fully reflected, it served as a primary driver of overall growth.Expansion of the GLP-1 obesity treatment market and demands for deviseThe strong performance of the Medication Delivery Solutions (MDS) division also contributed positively. The expansion of the GLP-1 obesity treatment market, currently a major topic in the pharmaceutical and biotech industry, is cited as a key contributor.BD Korea's booth at COPHEX 2025Last year, the company showcased the BD Vystra, a disposable pen device optimized for the administration of obesity treatments, and the BD Hylok, a pre-filled syringe for high-viscosity drugs, at major exhibitions such as COPHEX 2025.As the obesity treatment market shifts toward combination products in self-injection formats, the increased adoption of BD’s drug delivery solutions, which meet global standards, has been a key driver of the rising performance.Analysis suggests that the distribution of diagnostic equipment within the Life Sciences (BDB) division also contributed to the revenue increase.The next-generation flow cytometer, BD FACSLyric, achieved 200 units in domestic sales as of June 2025, demonstrating an overwhelming market share in the precision immune analysis market.Furthermore, the company solidified its leadership in the high-value equipment market by installing the 'BD FACSDiscover A8', which integrates real-time single-cell imaging technology, at major research institutions such as Yonsei University and Hallym University.This indicates a sustained increase not only in equipment sales revenue but also in future revenue from reagents and maintenance services.BD Korea plans to strengthen its 'End-to-End' integrated services, supporting the entire process from the early stages of biosimilar development to production, in line with the upcoming large-scale patent expirations of major biopharmaceuticals over the next decade.An industry official stated, "BD Korea has successfully transformed its business structure toward high-growth areas like patient monitoring and obesity treatment devices following the diabetes unit spin-off," and added, "Based on its strengths in the global supply chain and strategic partnerships with domestic pharmaceutical companies, the company's growth trend is expected to persist."
- Policy
- NHIS publicly discloses RSA Refund-type drugs
- by Jung, Heung-Jun Jan 06, 2026 08:25am
- Going forward, fewer patients are expected to miss out on refunds simply because they are unaware of refund-eligible drugs under Korea’s Risk-Sharing Agreement (RSA) system.On the 2nd, the National Health Insurance Service (NHIS) disclosed the “List of Risk-Sharing Refund-Eligible Drugs.” The aim is to improve information accessibility for patients who are prescribed refund-type drugs.There have been demands in the past from the National Assembly for information on refund-type reimbursed drugs. During the NA audit the year before the last, concerns were raised that patients were missing out on reimbursements due to a lack of information.Previously, lists of RSA drugs had been shared with medical institutions for the purpose of supporting patients subject to full out-of-pocket payments. However, this marks the first time the NHIS has directly disclosed the list of refund-type drugs to the general public.An NHIS official stated, “Starting in January this year, we plan to disclose the list of refund-type drugs on a monthly basis. This was a frequent request from patients, and addressing that need is the primary purpose. Following requests from the National Assembly, we reviewed the matter and decided on regular disclosure.”According to the refund-type RSA drug list released by the NHIS, there are 61 drugs under refund-type RSA contracts. These drugs are from 26 multinational companies and 3 domestic companies.When classified by dosage, the number of refund-eligible drug items reaches 112. Among them, AstraZeneca Korea (AZ) accounted for the largest share with 14 items.When categorized by dosage, 11 of the 112 refund-type items are from domestic companies. Multinational companies account for over 90% of the refund-type contract drugs.Domestic companies with refund-type RSA drugs include Yuhan’s Leclaza (lazertinib), JW Pharmaceutical’s Hemlibra (emicizumab), Handok’s Defitelio Inj (defibrotide), Vyxeos Liposomal Inj, and Pemazyre Tab (pemigatinib).Domestic companies are divided into those with domestically developed new drugs and those with overseas new drugs introduced to Korea, where they hold the local marketing rights. Among the refund-type drug list, domestically developed new drugs like Leclaza and multiple new drugs marketed by Handok stand out.Among multinational companies, AZ and Novartis Korea each had the most drugs, with 6 each. When including dosage distinctions, AZ accounted for 14 items.AZ has refund-type contracts for Tagrisso, Lynparza, Imfinzi, Koselugo, Strensiq, and Fasenra, while Novartis’ refund-type drugs include Kymriah, Kisqali, Zolgensma, Luxturna, Ilaris, and Lutathera.Other companies with multiple refund-type drugs include: ▲Pfizer Korea (Ibrance, Lorviqua, Vyndamax Cap, Paxlovid) ▲Eli Lilly Korea (Verzenio Tab, Cyramza Inj, Jaypirca Tab) ▲BMS Korea (Yervoy, Onureg, Camzyos, Inrebic).The reduction in drug expenditure through the RSA refund-type contracts has been largely concentrated on high-priced anticancer drugs and rare disease treatments from multinational pharmaceutical companies.
- Company
- 3 new K-biosimilar approvals last year…second-highest
- by Chon, Seung-Hyun Jan 06, 2026 08:25am
- Last year, South Korean biopharmaceutical companies received approval of three new biosimilar products. It was the second-highest annual output following the record-breaking eight approvals in 2024. Samsung Bioepis and Celltrion have seen their follow-up pipelines reach the commercialization stage one after another, while Sam Chun Dang Pharm successfully entered the market with its first biosimilar, expanding the number of domestic biosimilar players to five. Currently, Celltrion and Samsung Bioepis received 11 approved biosimilars each.According to industry sources on the 5th, domestic firms obtained approval from the Ministry of Food and Drug Safety (MFDS) for four new biosimilar products last year. Samsung Bioepis secured two of these approvals, while Sam Chun Dang Pharm obtained one. Samsung Bioepis received approval for Obodence (a biosimilar to Prolia) in April 2025, followed by Xbryk (a biosimilar to Xgeva) in May. Both Prolia and Xgeva were initially developed by Amgen, using the same active ingredient, denosumab, but with different dosing schedules and administration cycles. Prolia is used for treating osteoporosis, whereas Xbryk is indicated for preventing skeletal-related events in patients with bone metastases and for treating giant cell tumors of bone.In September 2025, Sam Chun Dang Pharm's Vgenfli, a biosimilar to Eylea (aflibercept), cleared its final regulatory hurdle. This product is indicated for ophthalmic conditions such as wet age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic macular edema. This marks Sam Chun Dang Pharm's first domestic biosimilar approval, entering a competitive field where Samsung Bioepis and Celltrion had already secured approvals for their respective Eylea biosimilars in 2024.The number of biosimilar approvals received by South Korean pharmaceutical and biotech companies by year (unit: number, source: MFDS)The three biosimilar approvals in 2025 were the second-highest in record. It recorded 9 in 2024, and the previous high was 3 in 2015 and 2022. Beyond new product entries, domestic firms are continuously strengthening their market competitiveness through supplemental formulation approvals.Celltrion obtained approval for an Auto-Injector (AI) formulation of Omlyclo in December 2025. This followed the June 2024 approval of the pre-filled syringe (PFS) version. Omlyclo is a biosimilar to Xolair (omalizumab), used for chronic idiopathic urticaria and asthma. The AI formulation is a unique option not currently offered by the original manufacturer in Korea, designed to enhance treatment accessibility for patients who find it challenging to visit medical institutions.Similarly, Celltrion added two new types of Avtozma (an Actemra biosimilar) in February 2025.Samsung Bioepis received approval for its Eylea biosimilar, Afilivu, in 2024, and introduced a pre-filled syringe version last year.To date, South Korean biopharmaceutical companies have successfully commercialized 27 products across 15 therapeutic areas.Celltrion pioneered this space in 2012 with Remsima and has since secured approvals for biosimilars referencing Herceptin, MabThera, Humira, Avastin, Eylea, Stelara, Xolair, Prolia, Xgeva, and Actemra.Samsung Bioepis began its journey in 2015 with Etoloce (Enbrel biosimilar) and has successfully expanded into areas referencing Remicade, Humira, Herceptin, Avastin, Lucentis, Soliris, Eylea, Stelara, Prolia, and Xgeva.LG Chem and Chong Kun Dang have also made notable entries into the Enbrel, Humira, Nesp, and Lucentis markets.Celltrion and Samsung Bioepis received approval for 11 biosimilars each. Celltrion and Samsung Bioepis account for 85% of the 26 approved products. Recently, traditional pharmaceutical companies have increasingly joined forces with these biosimilar developers for domestic distribution.While Samsung Bioepis initially partnered with MSD Korea, it later transferred rights to Yuhan Corp for several autoimmune treatments. However, in March 2024, Samsung Bioepis established its own internal sales organization for direct distribution. It currently maintains partnerships with Boryung for its oncology portfolio (Samfenet and Onbevzi) and Samils Pharmaceutical for its ophthalmology products. For Obodence, Samsung Bioepis selected Hanmi Pharmaceutical as its marketing partner, sharing domestic sales responsibilities.In 2017, Samsung Bioepis initially selected Daewoong Pharmaceutical as the sales partner for Samfenet but switched the distributor to Boryung in 2021. Immediately following the domestic approval of the Avastin biosimilar Onbevzi in 2021, the company signed an exclusive domestic sales agreement with Boryung. For its ophthalmic disease treatments, Samsung Bioepis chose Samil Pharmaceutical as the sales partner for its Lucentis and Eylea biosimilars.Samsung Bioepis recently selected Hanmi Pharmaceutical as the sales partner for Obodence. Samsung Bioepis acts as the developer responsible for production and supply, while both companies jointly manage domestic marketing and sales activities.Daewoong Pharmaceutical entered into a joint sales and distribution agreement with Celltrion Pharm to begin domestic sales of Celltrion's Prolia biosimilar, Stoboclo. Daewoong Pharmaceutical is conducting joint sales of Stoboclo across general hospitals and clinics nationwide alongside Celltrion Pharm. While Celltrion previously sold its biosimilars in the domestic market exclusively through its affiliate, Celltrion Pharm, Stoboclo is the first product from a pharmaceutical company other than Celltrion Pharm to be distributed in the domestic market. Additionally, Daewoong Pharmaceutical has joined LG Chem's sales efforts for its Humira biosimilar, Xelenka.
- Policy
- Rare disease drugs to be reimbursed within 100 days
- by Lee, Jeong-Hwan Jan 06, 2026 08:25am
- Starting in the new year, the government will shorten the timeline for National Health Insurance (NHI) reimbursement listing of rare disease treatments from the current 240 days to 100 days, strengthening patient access to medicines.To address frequent shortages of essential medicines, the government proposed ‘activating made-to-order manufacturing’ by establishing a public production and distribution network through collaboration between the government, pharmaceutical/distribution/medical associations, and pharmaceutical companies.Under this model, the government requests production of frequently out-of-stock drugs from manufacturers and purchases the entire output for supply.By expanding the emergency import of treatments and contract manufacturing, the government aims to create an environment where patients can obtain treatments without difficulty, even if private supply ceases due to low demand.In addition, patient co-insurance payments under the NHI special reimbursement calculation scheme for rare and severe intractable diseases will be further reduced.On the 5th, the Ministry of Health and Welfare (MOHW), the Ministry of Food and Drug Safety (MFDS), and other relevant agencies jointly announced measures to strengthen support for rare and severe intractable diseases. Rare Drugs to be listed within 100 days… approval-evaluation-pricing parallel review to continueFrom the new year, the government will significantly reduce the time required for NHI listing of rare disease treatments from within 240 days to within 100 days.Furthermore, the government will continue its pilot program for ‘parallel approval-evaluation-price negotiation’ for rare disease drugs, where it is difficult to establish robust efficacy and safety evidence due to extremely small patient populations. This program reduces the time required for drug price approval and listing from the current 330 days to 150 days, a reduction of 180 days.The first pilot program included Qarziba and Bylvay Cap, while the second pilot program is currently underway with three selected drugs.Prices for rare disease treatments will be set at a certain level relative to the average price in reference countries.Expansion of emergency import and made-to-order manufacturing for rare essential and shortage drugsFurthermore, to ensure access to treatments even if pharmaceutical companies halt manufacturing or imports due to low demand, the government is expanding emergency imports and custom manufacturing.First, medications for self-treatment that patients previously had to purchase directly overseas will be converted into emergency import items for at least 10 products starting this year to stabilize supply.Emergency import refers to a system in which the government directly procures drugs from overseas and supplies them when the domestic supply is disrupted.While an emergency import system already exists through the Korea Orphan and Essential Drug Center, ultra-low-demand products have often been excluded. Expanding the scope of emergency imports aims to address these limitations.If an emergency import drug was previously eligible for reimbursement, reimbursement price applications will be prioritized, and existing emergency import drugs will also be allowed to apply for reimbursement.In particular, to ensure a stable domestic supply of essential medicines at risk of discontinuation, the government will activate made-to-order manufacturing through a public production and distribution network involving the government, pharmaceutical companies, distributors, medical associations, and industry groups.Last year, KRW 810 million was allocated to manufacture 7 drugs through made-to-order manufacturing. This year, an additional KRW 500 million will be allocated to expand production to two more drugs.Under this system, the government shares information on drugs scheduled for supply discontinuation with the pharmaceutical industry. The Korea Orphan and Essential Drug Center analyzes prescription and supply history, demand, and regulatory issues, after which pharmaceutical companies decide whether to proceed based on production intent and required budget. Public production projects are then implemented through product transfer, new approvals, or manufacturing contracts.The government plan is to expand from the current 7 items to 17 items by 2030, adding 2 items annually starting this year.This would mean 25% of the 40 essential drugs requested for emergency import by the medical field would be converted to public production.When expanding emergency import and made-to-order-manufactured items, priority will be given to treatments for rare diseases.Reduced patient co-insurance costs through enhanced special reimbursement supportTo reduce the financial burden of high-cost care for patients with severe diseases, the government will strengthen special reimbursement schemes that lower NHI co-insurance payment rates.For high medical expenses related to rare and severe intractable diseases, the patient's co-insurance payment rate will be further reduced from the current 10%.Taking into account factors such as the need for continuous treatment and management and the burden of high medical costs, a reduction plan will be prepared in the first half of this year, followed by approval by the Health Insurance Policy Deliberation Committee, with implementation scheduled for the second half of the year.Furthermore, starting this January, 70 additional diseases, including congenital functional short bowel syndrome, will be added to the list of rare diseases eligible for special billing exceptions, with continuous expansion planned.The re-registration process for rare and intractable diseases will also be reorganized to be more patient-centerd. Until now, the government required separate test results for 312 specific rare and intractable diseases upon re-registration.Reflecting field feedback that additional testing is unnecessary given the incurable nature of these conditions, unnecessary testing requirements will be eliminated during re-registration.Support for low-income patients through the rare disease medical expense assistance program will also be expanded.The income and asset criteria separately applied to households with dependent family members will be phased out starting in 2027, expanding support for low-income individuals.Customized medical nutrition support based on disease-specific needs will continue to expand. The government currently provides special formula milk and low-protein instant rice to rare disease patients requiring dietary management. Since September last year, it has additionally provided special corn starch for patients with glycogen storage disease.This year, based on a survey of the current status of special diet usage and additional demand, the government plans to review expanding the range of supported items and support the development of new products.
- Policy
- Industry asks NHIS to defer February vote on drug price cuts
- by Lee, Jeong-Hwan Jan 06, 2026 08:25am
- The pharmaceutical industry is voicing concerns that the government's plan to push through a drug pricing system, which includes price cuts for domestically produced generic medicines, for approval by the Health Insurance Policy Deliberation Committee (HIPDC) next month (February), represents overly hasty administration.Industry consensus is that because the government failed to adequately collect industry opinions when it announced the reform plan late last November—lowering the pricing benchmark for generics from 53.55% of the originator price to the “40% range”—it is necessary to resume consultations in the new year before obtaining the approval of the Health Insurance Policy Deliberation Committee, and then set a new implementation date for the drug pricing system reform plan.The demand is that postponing or deferring the timing of the generic drug price reduction from July this year to next year or later is necessary to ensure domestic pharmaceutical companies' management predictability and the normal execution of their business plans.Some members of the National Assembly’s Health and Welfare Committee are also paying close attention to these concerns, raising questions over whether changes will occur in the government’s administrative timetable.According to domestic pharmaceutical industry sources on the 5th, the Ministry of Health and Welfare (MOHW), the government agency responsible for the drug pricing system reform plan, has not yet initiated a formal process to gather opinions from pharmaceutical companies regarding the reform plan, including generic drug price cuts and pricing incentives.On November 28 last year, the MOHW reported the reform plan to the HIPDC, publicly announcing its intention to reduce the generic pricing benchmark from 53.55% of the original drug’s price to the 40% range.At the same time, the ministry disclosed plans to finalize the reform through a HIPDC vote in February this year and to fully implement the revised pricing system and price reductions starting in July.At the time, domestic pharmaceutical companies reacted strongly, criticizing the ministry for abruptly announcing the plan without providing sufficient prior explanation regarding the specific pricing rate, the scope of generics subject to price cuts, or the targets and methods for pricing incentives.Pharmaceutical companies are criticizing the Ministry for failing to show any signs of reviewing or partially reflecting the industry's demands even now, over a month after the Health Insurance Review and Assessment Service report and into the new year.Industry stakeholders complain that the ministry has not retreated even marginally from its unilaterally disclosed proposal, instead adhering strictly to the government plan—creating an environment in which meaningful dialogue between the MOHW and the pharmaceutical industry cannot take place.In fact, Jeong-Kee Hong, Executive Director of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), strongly appealed for a deferral of implementation during a National Assembly policy forum on the drug pricing reform held last December, pointing out how the proposed timeline was excessively tight, undermining predictability, and that insufficient analysis had been conducted on the reform’s negative impact on the pharmaceutical industry.At the time, Executive Director Hong stated, “When pursuing drug price reductions, prior evaluation and analysis of the long-term impact on the pharmaceutical industry must be conducted first, and the effects on employment, production bases, and supply chains must also be examined. Notifying the industry of price reductions just 7 months before the system implementation makes it difficult for pharmaceutical companies to establish business plans and ensures no predictability.”Despite these industry appeals, the MOHW has shown little indication of establishing a consultation channel until now, prompting growing skepticism within the pharmaceutical sector regarding the plan to finalize the reform at the February HIPDC meeting.Against a backdrop of mounting uncertainty in the pharmaceutical industry—driven by the COVID-19 pandemic and rising trade barriers imposed by major economies such as the United States—industry voices warn that the MOHW’s focus on cutting health insurance expenditures, rather than regulatory innovation to support domestic new drug R&D, could ultimately threaten national security and pharmaceutical sovereignty.Accordingly, the pharmaceutical industry is expected to intensify calls for the MOHW to moderate the pace of its drug price cut measures.Mr. A, a drug pricing manager at a top domestic pharmaceutical company, stated, “We need to critically assess whether cutting generic drug prices to save KRW 1 trillion in health insurance funds is truly the top administrative priority the Ministry should pursue, given Korea's current situation. Throughout the prolonged COVID-19 pandemic, conflicts over medical policies and healthcare gaps, pharmaceutical companies have dedicated their management efforts to new drug R&D amid significant uncertainty. At this point, reducing generic prices to the 40% range is difficult to understand in terms of urgency or appropriateness.”Mr. B, another executive from a top pharmaceutical company, also stated, “While the Minister of Health and Welfare and the Vice Minister in charge of the pharmaceutical industry have consecutively published opinion pieces in media outlets expressing strong strong commitment to generic drug price reduction and strengthening the sustainability of the national health insurance finances, there has been no visible effort to establish a discussion table for collecting industry feedback on their strong opposition. Rather than repeating and reinforcing the government's drug pricing system reform plan already reported to the HIPDC, what is needed now is a consultative approach that proactively accommodates industry demands and promises the possibility of revising the reform plan.”As industry opposition persists, the National Assembly is closely monitoring the MOHW’s handling of the pricing reform.Some members of the Health and Welfare Committee are questioning the rationality of rushing implementation without sufficiently accommodating industry concerns, and there is a growing sense that legislative mediation may be necessary if government–industry tensions escalate.An official from a ruling-party lawmaker’s office on the committee remarked, “There is concern that the policy of applying differential pricing to generics for domestic pharmaceutical companies that have expanded investment in new drug R&D was not sufficiently reflected in this drug pricing system, and we partially share that view. We are currently communicating with the pharmaceutical industry to determine whether the MOHW’s drug pricing system reform truly sends a policy signal encouraging competition based on innovation rather than rebates.”The official continued, “It's difficult for the National Assembly to hastily take on the legislative branch's mediation role before conflicts even arise. The domestic pharmaceutical industry has sufficiently voiced its opposition to the policy, and since the consultation process with the government is still ongoing, we need to observe the situation a bit longer. If the government implements the drug price reduction reform plan quickly and the resulting shock to the pharmaceutical industry is significant, then some level of incentive measures should follow to offset it to a certain extent."
