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- 2026-06-10 22:03:18
- 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."
- Policy
- MFDS establishes dedicated division to accelerate biosimilar reviews
- by Lee, Tak-Sun Jan 05, 2026 10:39am
- The establishment of a dedicated division for biopharmaceutical approvals is expected to accelerate the review process for domestically developed biosimilars.The Biopharmaceutical Approval Division has been formally incorporated into the Biopharmaceuticals and Herbal Medicine Bureau. With the Biologics Approval Task Force (TF), which began operations in 2024, having been elevated to a permanent division, the review of related products is expected to gain momentum, alongside last year's increase in biosimilar fees.According to the Ministry of Food and Drug Safety (MFDS) on the 1st, the Biopharmaceutical Approval Division was newly established as of the 30th of last month. Hyun-jung Park, a senior civil servant who previously led the TF, has been appointed as division director.Notably, the Biopharmaceutical Approval Division is expected to focus on shortening biosimilar review periods by organizing dedicated teams to review each product.The biosimilar approval review fee was raised last September from the previous KRW 8.03 million to KRW 310 million. The MFDS has stated that it aims to significantly reduce approval timelines using the additional resources secured through the fee increase.Hyun-jung Park, Director of the Biopharmaceutical Approval DivisionDuring a recent presidential policy briefing, MFDS Minister Yu-kyoung Oh announced plans to reduce the average review period for new drugs and biosimilars to 240 days. The current average review timelines are 420 days for new drugs and 406 days for biosimilars. If achieved, this would effectively cut review periods by nearly half.The key to shortening review timelines lies in operating dedicated review teams. By concentrating reviews on a per-product basis, the MFDS aims to eliminate unnecessary delays. The Biopharmaceutical Approval Division is expected to play a central role in this effort.The Ministry of Food and Drug Safety (MFDS) introduced a new expedited review system last year alongside increased fees for new drugs. This system involves forming dedicated product teams (18 members) incorporating specialized personnel for new drug approvals, prioritizing the review of Good Manufacturing Practice (GMP) reviews, and providing customized face-to-face meetings both before and after marketing authorization applications.The establishment of the Biopharmaceutical Approval Division is widely interpreted as an effort to extend this expedited review framework to biopharmaceuticals. All 13 members of the former Biologics Approval TF have been transferred to the new division.Since 2024, the Biologics Approval TF has been responsible for handling approval-related petitions, including preliminary reviews, coordination requests (covering GMP, review processes, risk management plans, and patent issues), issuance of requests for additional data, and approval of extensions for response periods when necessary, and coordination of responses from relevant departments.
- Policy
- Rebate penalty in innovative pharma certification reform
- by Lee, Jeong-Hwan Jan 05, 2026 10:39am
- The pharmaceutical industry's attention is drawn to the Ministry of Health and Welfare's (MOHW) proposed reform of the Innovative Pharmaceutical Company certification system.The MOHW is considering a transition from the current 'cancellation of innovativeness certification' rule for illegal rebates to a points-based scoring system.While the MOHW initially announced a shift toward a scoring system, which would give incentives towards new drug development from pharmaceutical companies rather than a penalty disqualifying the certification, it has faced significant pushback from those expressing concerns.On January 2, the pharmaceutical industry is currently anticipating an administrative measure related to rebates concerning innovative pharmaceutical company certification system reform that can sufficiently encourage R&D investment.Even if the current disqualification rules for illegal rebates are maintained without a transition to a scoring system, the industry's demand is for a reasonable reform that prevents certification cancellation for cases that occurred long ago.The industry argues that for R&D plans to be maintained, regulations should be established to ensure that certification is not revoked for extremely old rebate cases or for instances where court rulings determined the company did not actively participate in the illegal activity.The MOHW plans to issue a legislative and administrative notice within January after receiving feedback from both domestic and international pharmaceutical companies. The MOHW noted that the original schedule for the notice was delayed due to the process of gathering diverse opinions from stakeholders.An official from a domestic pharmaceutical company explained, "The MOHW seems to be considering various administrative directions regarding the transition to a scoring system," and "It is crucial that the unreasonable cancellation rules be updated rather than a focus on transitioning to a score system. The goal of the certification is to provide preferential treatment to companies that are dedicated to new drug R&D."
- Policy
- 'Platform wholesaler ban law' forum faces backlash over bias
- by Lee, Jeong-Hwan Jan 02, 2026 08:00am
- Rep. Hankyu Kim of the Democratic Party of Korea (center) hosted an emergency forum titled 'Asking the Venture Industry's Opinions on the Pharmaceutical Affairs Act Amendment' on December 16.Rep. Hankyu Kim of the Democratic Party of Korea received criticism from the healthcare and medical communities for openly opposing a bill that would prohibit platforms from also serving as pharmaceutical wholesalers. Rep. Kim opposed this bill, which passed the Health and Welfare Committee and theLegislation and Judiciary Committee with agreements reached by both parties, during an emergency National Assembly forum that he hosted.During the forum, Rep. Kim reportedly voiced strong opposition to the statement from a division head from the Ministry of Health and Welfare (MOHW), the primary department responsible for the proposed amendment to the Pharmaceutical Affairs Act. Some in the medical community expressed concern that the "host lawmaker appeared to be targeting the official by demanding an immediate change in stance or a revision to the legislative proposal". Objections have been raised that the forum was operated with a coercive manner, essentially ordering the ministry to draft an amendment in favor of platform industries and startups for a bill that is already awaiting a final plenary session vote.During the emergency forum on December 16, Rep. Kim stated, "Today’s seminar was co-hosted by 10 members of 'Unicorn Farm', but if the MOHW does not listen to the opinions [of startups and VCs], I will gather 20 members next time for a seminar. If that is still insufficient, I will gather 30 members for discussion."On December 17, representatives from the medical community and bipartisan officials from the National Assembly’s Health and Welfare Committee evaluated Rep. Kim's remarks as biased. They noted that holding a division head responsible for follow-up measures regarding a bipartisan agreement that has already cleared the Welfare and Judiciary committees is likely to draw criticisms of partiality.Medical industry insiders and committee officials argued that the operational direction of the forum, titled "Asking the Venture Industry's Opinion on the Doctor Now Prevention Act," could be perceived as an attempt to intimidate the MOHW administration, which is working to protect public health and the drug distribution ecosystem.Jun-Hyuk Kang, Director of the Pharmaceutical Policy Division at the MOHW, stated during the event, "The Pharmaceutical Affairs Act amendment is different from the 'Tada Ban Law.' The expression 'Doctor Now Prevention Act' is also incorrect, and it is not a law that hinders innovation." He explained, "If a platform operates a wholesaler, it cannot be free from the incentive to drive the prescription and dispensing of its own distributed medications. This law is designed to prevent such conflicts of interest."Kang's statement implied that the delay in passing the bill, which has stalled despite clearing committees, must be resolved to prevent telemedicine platforms from abusing the system for private profit.Immediately after Kang's statement, Rep. Kim continued with remarks that appeared to demand an immediate revision of the bill.Rep. Kim said, "Just because the MOHW says I shouldn't call it a 'Tada Ban Law' doesn't mean I can't. Because many people see it that way, I call it the second 'Tada Ban Law,' and I believe 'Doctor Now Prevention Act' is an accurate term." He added, "The MOHW seems to question why companies enter the platform wholesale business, but what business a company chooses to conduct should be a matter of corporate freedom."Rep. Kim continued, "It is unreasonable for the MOHW to judge whether something constitutes innovation. While the ministry wants to separate the dispensing and prescription of drugs from wholesaling, the correct legislative approach would be to regulate specific conduct, such as penalizing a wholesaler or platform that negatively influences a pharmacist’s prescription or forces generic substitution, rather than banning the wholesale business itself." He argued, "It is strange to insist on this amendment just to block a wholesaler that distributes 90 types of drugs, as Doctor Now does."Rep. Kim further challenged the official, saying, "I could offer a rebuttal to every single point the MOHW makes. I am questioning the procedural legitimacy. I believe the ministry should state its willingness to seek alternatives to the venture industry's opinions. What is most disappointing is that, based on the division head's words today, the MOHW seems to have no intention of changing its position or engaging in further discussion. Is it the official position of the department that no further discussion is possible?"As these remarks became public, the healthcare community questioned whether the emergency forum was intended solely to pressure the MOHW.A pharmaceutical industry official noted, "I heard that Rep. Kim openly pressured the ministry for a revision. Why demand a modification from the MOHW for a bill that secured bipartisan agreement and is awaiting a plenary vote? Remarks about gathering 20 or 30 lawmakers if the ministry doesn't comply sound like a threat."The official added, "The delay in the Pharmaceutical Affairs Act amendment is a matter that could shake the domestic healthcare system and the public health safety net," and added, "Dismissing doctors and pharmacists as focused on protecting their own turf, while framing platforms and startups as the 'weak' party to block the bill, is an act that ignores people’s right to health and life."The official said, "Despite numerous explanations for the legislation and reports of illegal platform activities during the pilot project, Rep. Kim’s insistence on protecting specific corporate interests through a distorted frame is difficult to understand," and concluded, "This attempt to modify the bill will only increase the burden on the Democratic Party, the government, and the President."
- Policy
- Gvn’t to invest over ₩1T in Medical AI, Pharma, and Biohealth in 2026
- by Lee, Jeong-Hwan Jan 02, 2026 07:43am
- The Ministry of Health and Welfare (MOHW) will invest more than KRW 1 trillion in healthcare research and development (R&D) in the new year (2026).On the 31st, the ministry announced its integrated implementation plan for next year's R&D projects and simultaneously issued the first integrated call for research proposals for 19 healthcare R&D projects. The budget allocated for new projects is KRW 171.5 billion, while KRW 62.5 billion will be invested across the 19 projects in the first call.The MOHW’s total R&D budget for 2026 amounts to KRW 1.0652 trillion, representing a 12.6% increase year on year.Of the 83 total R&D programs, KRW 1.0014 trillion has been allocated to 69 ongoing programs, while KRW 63.8 billion will be invested in 14 new programs. Over the past five years, the ministry’s R&D budget has grown at an average annual rate of 11.1%.The Ministry will pursue this R&D investment centered on four key strategic pillars: technological innovation for public health, securing future growth engines in biohealth, AI-based digital and medical innovation, and establishing a foundation for biohealth innovation.The total scale of new projects for 2026 is KRW 171.5 billion. A first integrated call for proposals will be conducted for projects scheduled to begin in April (19 projects, KRW 62.5 billion).The application period runs from December 31, 2025, to 2:00 PM on January 30, 2026. Research institutions will be selected in April to commence research. Projects scheduled to begin in July (6 projects, 15.9 billion won) will be recruited through a second consolidated call in April 2026.Key new programs included in the first integrated call are dementia medical technology R&D, patient safety technology development, technology development to address suicide-related social issues, translational clinical research in anti-aging and reverse-aging regenerative medicine, establishment of an AI-based surgical robot innovation lab, structure-based AI drug discovery, advanced bio convergence talent cultivation, recruitment of top-tier overseas talent, K-MediST support, and the Health and Medical R&D Core Technology Early Boost Program.In addition, new projects will be selected and supported under nine ongoing programs, including global physician-scientist training, translational research linked to clinical field demand, and technology development to address low birth rates. Starting with new projects in 2026, researchers must submit a research data management plan when applying for a project, and data obtained during the research process must be managed according to a standardized format.Eun-young Jung, Director General of the Bureau of the Health Industry Policy at the Ministry of Health and Welfare, stated, “The role of healthcare R&D is critical for the development of sustainable medical and care technologies and the expansion of biohealth exports. We look forward to active participation from researchers in the new projects for 2026.”Soon-do Cha, President of the Korea Health Industry Development Institute (KHIDI), said, “We will do our utmost to support researchers so that R&D outcomes translate into tangible benefits for the public.”
- Policy
- Third vitamin-based acne treatment approved in KOR
- by Lee, Tak-Sun Jan 02, 2026 07:43am
- Dongwha Pharmaceutical’s nicotinamide-based acne treatment, “Sevita B Gel”Since the first vitamin-based acne treatment was launched in Korea in 2022, other pharmaceutical companies have begun turning their attention to the market. Following Dongwha Pharmaceutical, Chong Kun Dang, and Dong-A Pharmaceutical have now also secured product approvals.On the 29th, the Ministry of Food and Drug Safety (MFDS) approved Dong-A Pharmaceutical’s “Acvita Gel” (over-the-counter drug). Acvita Gel contains nicotinamide and is used for the topical treatment of mild to moderate inflammatory acne.The recommended dosage is to apply a sufficient amount to the affected area twice daily, morning and evening. Each tube contains 30 grams.Nicotinamide is known as the active form of vitamin B3. It helps improve acne symptoms through its anti-inflammatory action.The acne-fighting effects of nicotinamide have already been confirmed in numerous studies and papers. Consequently, products containing nicotinamide, such as Nicomed Cream and Prederma Gel, have long sold overseas.In Korea, the ingredient was first introduced in June 2022, when Dongwha Pharmaceutical launched “Sevita B Gel,” a product containing the same active ingredient.Subsequently, in October last year, Chong Kun Dang received approval for ‘Dermagram Gel’, a pharmaceutical product with the same ingredient. Now, with Dong-A Pharmaceutical's ‘Acvita Gel’ added, three products have been listed.Dong-A Pharmaceutical expects Acvita Gel to generate synergies with its steady seller, “Noscarna Gel.” Noscarna Gel is used for the treatment of hypertrophic and keloid scars, acne scars, and post-surgical scars, and has established itself as a leading acne scar treatment with annual sales exceeding KRW 10 billion.The nicotinamide-based acne treatment also offers advantages over existing prescription drugs, having the advantage of not inducing resistance and being conveniently available as an over-the-counter drug. Dongwha Pharmaceutical's Sevita B Gel recently recorded high growth rates among the company’s OTC products, further boosting expectations for other products containing the same ingredient.
- Policy
- 8 items, including Infanrix, will be discontinued next year
- by Jung, Heung-Jun Dec 29, 2025 08:55am
- Product photo of GSK's Infanrix-IPV+Hib Inj, Yuhan Corporation's Bambec Tab, and Hanall Biopharma's Cortisolu InjectionEight items, including GSK's hexavalent combination medicine (included in the National Immunization Program (NIP)), will be discontinued for supply starting next year. On the 2nd of next month, the list of items subject to supply suspension, along with their scheduled dates, will be shared on the drug utilization review (DUR) system.The Health Insurance Review and Assessment Service (HIRA) the list of items reported to be suspended for next year's production, imports, and supply shared with relevant organizations and associations.According to the relevant association on December 26, eight items from seven companies, including Eisai Korea, GSK, and Hanall Biopharma, will be discontinued for supply next year.The included items are ▲Hanall Biopharma's Cortisolu Injection (hydrocortisone sodium succinate) ▲Daewoo Pharm's Tobeson Eye Drops (tobramycin, dexamethasone) ▲Tai Guk Pharm's Hyrosone Cream (hydrocortisone) and Gammarin D Liquid ▲Yuhan Corporation's Bambec Tab 10mg (bambuterol hydrochloride) ▲Genuone Sciences' Pencivir Cream (penciclovir) ▲GSK's Infanrix-IPV+Hib Inj ▲Eisai Korea's Plegridy Pen Inj Starter Pack (peginterferon beta-1a, recombinant), among others.Infanrix-IPV+Hib is a hexavalent combination vaccine supplied for the NIP for infants. It is a vaccine that simultaneously prevents meningitis, pertussis, and polio.The relevant vaccination market has been split between Sanofi's Pentaxim and Infanrix. Following the discontinuation of Infanrix on June 30 of next year, demand is expected to shift to Pentaxim from the second half of the year.The list of pharmaceuticals subject to discontinued supply (January 2026): ▲Hanall Biopharma's Cortisolu Injection (hydrocortisone sodium succinate) ▲Daewoo Pharm's Tobeson Eye Drops (tobramycin, dexamethasone) ▲Tai Guk Pharm's Hyrosone Cream (hydrocortisone) and Gammarin D Liquid ▲Yuhan Corporation's Bambec Tab 10mg (bambuterol hydrochloride) ▲Genuone Sciences' Pencivir Cream (penciclovir) ▲GSK's Infanrix-IPV+Hib Inj ▲Eisai Korea's Plegridy Pen Inj Starter Pack (peginterferon beta-1a, recombinant), among others.Eisai Korea's Plegridy Pen Inj is a new drug for relapsing multiple sclerosis that received domestic approval in 2016 and was listed for reimbursement in 2017. As a recombinant treatment for a rare disease, the decision to discontinue supply was made approximately 10 years after its introduction. Supply will be discontinued starting June 30 of next year, the same time as Infanrix.Hanall Biopharma's Cortisoru Inj will be discontinued starting July 1 of next year. As a corticosteroid, it is expected to be replaced by more than 20 other drugs available in the same therapeutic class.With AstraZeneca’s decision to withdraw Bambec Tab. from the market 31 years after its domestic approval, Yuhan Corporation will also cease sales and supply after December of next year.Bambec Tab is a long-acting beta-adrenoceptor agonist (LABA) used to treat asthma, chronic bronchitis with bronchospasm, emphysema, and other lung diseases. Since combination therapies have been increasingly used for asthma treatment recently, the decline in market competitiveness is considered the reason for the withdrawal.The HIRA plans to provide information on the eight items scheduled for discontinuation next year to physicians and pharmacists through the DUR system on the 2nd of next month.
- Policy
- Imjudo, Imfinzi, Xpovio in reimb discussions with NHIS
- by Jung, Heung-Jun Dec 26, 2025 08:40am
- Imjudo (tremelimumab) and Imfinzi (durvalumab) are in price negotiations with Korea’s National Health Insurance Service (NHIS), bringing the drugs closer to reimbursement listing.Once they clear the final hurdle with the NHIS, Imjudo will be newly reimbursed for use in combination with Imfinzi in hepatocellular carcinoma, while Imfinzi is expected to secure a reimbursement expansion for use in combination with gemcitabine and cisplatin in biliary tract cancer.According to industry sources on the 26th, the NHIS is conducting price negotiations for three new drugs and two coverage expansion items.These drugs all passed the Drug Reimbursement Evaluation Committee in November. AstraZeneca Korea is negotiating the reimbursement of both Imjudo and Imfinzi simultaneously.If negotiations conclude as expected, Imfinzi will secure reimbursement for two combination regimens at once: combination therapy with Imjudo and the GemCis (gemcitabine + cisplatin) regimen.AstraZeneca is expected to expand Imfinzi’s use beyond its previous focus on lung cancer into liver cancer and biliary tract cancer.AstraZeneca is expected to expand Imfinzi prescriptions, previously focused on lung cancer, to include liver and bile duct cancers.Additionally, new drugs under negotiation include Janssen Korea's Balversa Tab 3, 4, 5mg (erdafitinib) and Takeda Korea's Takhzyro Prefilled Syringe 300mg (lanadelumab).Balversa Tab, a new targeted therapy for bladder cancer, received reimbursement adequacy approval for treating adult patients with locally advanced or metastatic urothelial carcinoma. Takhzyro Prefilled Syringe received reimbursement adequacy approval for preventing attacks of hereditary angioedema in adults and adolescents. Both products are now awaiting final price agreements.Xpovio 20 mg Tab (selinexor) from Antengene, which received reimbursement expansion approval alongside Imfinzi in November, has also entered price negotiations. Xpovio was approved for reimbursement expansion for use in combination with bortezomib and dexamethasone in adult patients with multiple myeloma who have received at least one prior therapy.However, unlike the other products, Xpovio’s approval came with a conditional clause stipulating that reimbursement expansion is deemed appropriate only if the company accepts a price at or below the evaluated price. If the company is unable to accept the proposed price, there remains a possibility that negotiations could break down.
- Policy
- Second generic for prostate cancer drug Xtandi approved
- by Lee, Tak-Sun Dec 26, 2025 08:40am
- Pharmaceutical companies are rapidly entering the generic market for the prostate cancer treatment ‘Xtandi (enzalutamide)’, which has a market worth approximately KRW 50 billion.Following Alvogen Korea's initial product approval last January, Daewon Pharmaceutical has also successfully obtained approval for its generic drug. These products are expected to establish patent strategies targeting launch after the substance patent expires next June.The Ministry of Food and Drug Safety approved Daewon Pharmaceutical's ‘Enzadex Soft Cap 40mg’ on the 23rd. This product is the second generic drug containing the active ingredient enzalutamide.The first generic was Alvogen Korea's ‘Anamide Soft Cap 40mg’, approved last January. A common feature of both Alvogen Korea and Daewon Pharmaceutical's products is that they import the finished drug from Taiwan.Enzadex Soft Cap is indicated for ▲ treatment of asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC), ▲ treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel, ▲ treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (mHSPC), ▲combination therapy with androgen deprivation therapy (ADT) for the treatment of patients with hormone-sensitive metastatic prostate cancer (mHSPC), ▲treatment of patients with high-risk hormone-sensitive non-metastatic prostate cancer (nmHSPC) who have experienced biochemical recurrence (BCR). These indications are identical to those of the original Xtandi Soft Cap 40mg.Xtandi’s formulation patent is set to expire on June 27 next year. However, a formulation patent valid until September 11, 2033, remains a key barrier to generic entry. As a result, multiple generic manufacturers have initiated legal actions to challenge or circumvent the formulation patent.Starting with Alvogen Korea in August, GL Pharma, Hanmi Pharmaceutical, Chong Kun Dang, JW Pharmaceutical, and Kuhnil Pharmaceutical have filed passive scope confirmation trials aimed at clearing the formulation patent hurdle.Industry analysts suggest that if the formulation patent is successfully overcome, generics could enter the market as early as June next year.Astellas' Xtandi competes in the first-line prostate cancer treatment market against drugs like Erleada (apalutamide, Janssen) and Zytiga (abiraterone, Janssen).Notably, since November 2023, the patient coinsurance rate has decreased from 30% to 5%, leading to increased usage. According to the pharmaceutical market research institution IQVIA, Xtandi's sales surged from KRW 23 billion in 2019 to KRW 43.2 billion in 2023.As the market expands, domestic pharmaceutical companies are also eagerly entering the prostate cancer treatment market. Hanmi Pharmaceutical has already moved aggressively by launching Abiteron Tab 500 mg, the first generic version of Zytiga, to secure early market share.With Xtandi’s patent expiry approaching, many generic manufacturers are now closely monitoring the opportunity. Generic companies are simultaneously advancing patent litigation strategies and regulatory approvals, aiming for early entry in June next year.Meanwhile, Astellas has preemptively obtained approval for Xtandi Tab, a new formulation last year, to counter the wave of emerging generic drugs. This appears to be a strategy to dilute the market impact of generic drugs by introducing a new formulation product.
