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- 2026-04-23 17:02:34
- Policy
- Generic Tagrisso and Xtandi approved in Korea
- by Lee, Tak-Sun Jan 29, 2026 08:16am
- Chong Kun Dang and Menarini have each received approval for generic versions of the oncology drugs Tagrisso and Xtandi, respectively.Particularly noteworthy is Chong Kun Dang's success in becoming the first in Korea to commercialize a generic version of Tagrisso, raising attention as to whether this will translate into early market entry.On the 27th, the Ministry of Food and Drug Safety approved two dosage strengths of Chong Kun Dang’s ‘Otinib Tab’ as well as Menarini Korea’s ‘Enzalex Soft Cap 40 mg.’CKD’s Otinib is the first approved generic version of osimertinib in Korea. The original product containing osimertinib is AstraZeneca’s Tagrisso.Both Tagrisso and Otinib are indicated for patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.Tagrisso recorded KRW 111 billion in domestic sales in 2023 (IQVIA data). Yuhan’s Leclaza (lazertinib) is its key competing product. Given its high commercial value, multiple later entrants are seeking early access to the market.CKD has taken on the challenge to circumvent Tagrisso’s formulation patent, which is scheduled to expire in January 2035. Avoiding this patent would allow market entry in 2033, when Tagrisso’s compound patent expires. Kwangdong Pharmaceutical is also attempting the same patent challenge.Although Otinib has now received regulatory approval, active market launch is not yet possible due to the remaining compound patent.Nevertheless, analysts suggest that securing a priority marketing approval (generic exclusivity) to capture the generic market first could lead to high sales.Menarini’s Enzalex Soft Cap contains enzalutamide as the active ingredient. The originator product is Astellas’ Xtandi and is used to treat prostate cancer. Xtandi recorded KRW 43.2 billion in domestic sales in 2023, according to IQVIA.This is not the first approval of an Xtandi generic in Korea. Last year, Alvogen Korea and Daewon Pharm received approvals for Anadin Soft Cap and Enzadex Soft Cap, respectively. Earlier this month, HanAll Biopharma also succeeded in listing its enzalutamide generic, Enzaluta Soft Cap, on the MFDS approval registry.With Xtandi’s compound patent set to expire in June, the opening of its generic market later this year is considered a strong possibility.However, a key variable remains the formulation patent for enzalutamide, which is scheduled to expire in September 2033. Generic manufacturers have filed patent invalidation or circumvention actions targeting this formulation patent. Whether they succeed in avoiding the patent will determine if launches occur within the year.
- Policy
- KSPST 'Generic drug price cuts not right for fiscal savings'
- by Lee, Tak-Sun Jan 29, 2026 08:16am
- Cheong-won Cho, the newly appointed president of the Korean Society of Pharmaceutical Science and Technology (KSPST), expressed a critical view of the government’s policy to lower generic drug prices, stating that such an approach is not logically consistent if the objective is to reduce National Health Insurance (NHI) spending. She argued that to reduce NHIS spending, the use of generic drugs should be promoted rather than cutting their price.Cho made the remarks during a press briefing held on the 28th at a restaurant in Yeoksam-dong, Seoul. “Given concerns about the depletion of the NHI fund, policies aimed at narrowing financial gaps are necessary. However, lowering generic drug prices as a means of reducing NHI expenditure seems illogical.”“Lowering generic drug prices would have a devastating impact on pharmaceutical companies' profits, leading to workforce reductions and decreased R&D investment. The government claims that lowering generic drug prices will encourage increased investment in new drug development, but I believe the government and the pharmaceutical industry are heading in different directions on this point.”“It's not that the government's position is wrong, but rather than focusing on lowering generic drug prices, they should seek various methods to prevent the depletion of the national health insurance fund. I think it would be good if the government held a close ear to the input from relevant academic circles and organizations and considered the overall situation to restructure the system based on a predictable scenario.” President Cho explained that activation of generics following patent expiration of originator drugs is, in itself, beneficial to NHI finances.This was Cho's first meeting with the press after being appointed President of KSPST. Currently a professor at Chungnam National University College of Pharmacy, she expressed her ambition for strengthening the society’s internal capabilities while expanding its external influence.Cho said, “As pharmaceutics advances, regulatory environments are becoming more complex and global competition more intense. We will establish a robust academic framework and build effective R&D programs. To expand our reach, we will form consortia with domestic and international academic societies and foreign journals, and establish a systematic framework to support the society's sustained growth.”The newly appointed executive board of the Korean Society of Pharmaceutical Science and Technology poses for a commemorative photo after concluding a press conference on the 28th. (From left: Scientific Program Committee Chair Jin-wook Yoo, General Affairs Committee Chair Sangkil Lee, President Cheong-won Cho, Secretary General Yu Seok Yoon, Public Relations Committee Chair Jun-Bom Park)Yu Seok Yoon, Secretary General of KSPST, who also attended the event, said, “The society must serve as a bridge between basic science and clinical practice. We will continue to expand into areas where social and academic demand exists.”Founded in 1971, KSPST is a reputable academic organization that has dedicated 54 years to advancing pharmaceutical research and scholarship. It has approximately 1,200 members and has contributed to the development of the pharmaceutical industry and the promotion of public health through the dissemination of pharmaceutical R&D achievements and industry collaboration.Last year, the society shared the latest developments in pharmaceutics through the Formulation Technology Workshop and an International Academic Conference. The Formulation Technology Workshop drew participation from approximately 500 experts from industry, academia, and research institutes. Its International Academic Conference also gathered over 650 attendees, including 36 domestic and international speakers from 11 countries, marking its largest-ever participation.This year’s major events include a Science Month symposium on April 10, a Formulation Technology Workshop on September 18, and the Society’s General Assembly and International Conference from November 25 to 27.Jin-wook Yoo, Chair of the Scientific Program Committee, noted, “Through our academic conferences, we aim to strengthen industry-academia-research collaboration by pursuing both academic depth and industrial applicability. We plan to establish an academic foundation for the pharmaceutical-biotech sector's leap forward and organize conference sections reflecting the latest technological trends.”
- Policy
- “What we need is competition, not rebates”
- by Lee, Jeong-Hwan Jan 28, 2026 08:12am
- “Stop the meaningless debate on what percentage the government is willing to adjust the generic drug calculation rate. Lowering drug prices will simply increase prescription volume, so it won't lead to savings in drug expenditures. The government must regulate rebates to create an environment where lower-priced drugs are prescribed more frequently. That's how we achieve savings in the national health insurance budget.”Academic experts view that lowering generic drug reimbursement rates alone, even if the government reduces the generic pricing formula from 53.55% to the 40% range, will not lead to savings in the National Health Insurance (NHI) budget.In other words, simply lowering the generic drug calculation rate, which has led to repeated battles between the MOHW and the industry, will not lead to actual drug cost savings. Rather, the government should focus on eliminating illegal rebates and establishing a market-driven drug pricing environment to save the National Health Insurance and foster the growth of the domestic pharmaceutical industry.At a National Assembly policy forum on drug pricing reform held on the 26th, Professor Hye-young Kwon of the Department of Health Administration at Mokwon University said, “Creating an environment where lower-priced, cheaper drugs are more widely prescribed in the market is what will save NHI finances.”According to Kwon, the ongoing standoff between the government and the pharmaceutical industry over generic pricing percentages will not translate into actual reductions in pharmaceutical expenditure.Kwon also expressed “serious concern” on how the MOHW’s drug pricing reform proposal was announced without sufficient social consensus or prior consultation with stakeholders in the pharmaceutical industry.She further stated that discussing NHI fiscal sustainability solely through adjustments to generic pricing formulas is inherently unreasonable and significantly ineffective.Her logic is that even if the generic drug price calculation rate is drastically lowered from 53.55% to 40%, the amount of drugs prescribed in the market will increase substantially due to lower prices. Consequently, the NHI funds spent on drug costs will remain at the same level before and after the reduction.Kwon advised the Ministry of Health and Welfare that instead of targeting NHIS savings through the generic drug calculation rate, it should devise and implement policies enabling low-cost generics to gain market share. Only then can NHIS savings be successfully achieved.She argued that the current situation, where pharmaceutical companies manipulate prescription volumes through illegal rebates, must be aggressively addressed, stressing the need to create an environment where generics that offer lower prices and higher quality can increase market share.Kwon stated, “There was no social consensus or public deliberation process before the Ministry of Health and Welfare announced the drug pricing system. Personally, it was a very disconcerting announcement. "Reducing health insurance expenditures depends on policies leveraging generics. I find it incomprehensible that they are discussing pricing cuts like lowering the reimbursement rate to the 40% range.““No matter how much you lower generic prices, NHI spending will not decrease. As prices fall, prescription volumes rise proportionally. To date, the MOHW has never successfully reduced healthcare spending through generic pricing policies. Drug prices only fall meaningfully when they are subjected to genuine market competition, guided by the invisible hand.”“The reason Korea has failed to let market forces work is that prescriptions are driven not by lower prices, but by the amount of rebates. The MOHW has failed to establish policies that ensure lower-priced generics gain greater market share, resulting instead in the proliferation of increasingly small-scale, mom-and-pop-style pharmaceutical companies.”“Domestic drug costs are driven by the extremely high prices of off-patent originator drugs. Yet, no advanced country allows originator drugs after patent expiry to generate such high profits. That value should be captured through price competition by domestic generic manufacturers. Only by replacing rebate competition with price competition can Korea simultaneously strengthen its pharmaceutical industry and ensure the long-term sustainability of the national health insurance system.”
- Policy
- “Drug price reform may bring collapse of generic self-sufficiency”
- by Lee, Jeong-Hwan Jan 27, 2026 06:55am
- Concerns have been raised that if the government’s drug pricing reform, which focuses on generic drug price cuts, is pushed forward without revision, a growing number of domestic pharmaceutical companies will abandon local generic production, ultimately shaking the foundation of Korea's pharmaceutical sovereignty.Critics warn that such an outcome could weaken new drug R&D, increase dependence on overseas sources for both active pharmaceutical ingredients (APIs) and finished drugs, and, in the long run, lead to shortages in domestic generic supply and greater reliance on originator products, making it difficult for the government to achieve its goal of reducing National Health Insurance spending.In particular, as the reform plan announced in late November last year was drafted without sufficient consultation with the pharmaceutical industry, industry experts believe the plan should be revised after ample discussion and then be implemented gradually.On the 26th, attorney Kwan-woo Park of Kim & Chang and attorney Hyun-wook Kim of Shin & Kim (Sejong) outlined the limitations of the Ministry of Health and Welfare’s reform plan and proposed improvements at a National Assembly policy forum on drug pricing reform.“Generics should be viewed as a measure to ensure public access, not merely low-priced drugs”Attorney Park pointed out that the Ministry of Health and Welfare's current drug pricing system reform plan is similar to the 2012 policy of across-the-board price cuts for generic drugs.He noted that although drug expenditure initially declined after the 2012 cuts, spending rebounded to previous levels in just two years. At the same time, production of non-reimbursed drugs, which were not subject to price cuts, increased, employment in the pharmaceutical sector declined, and yet the Ministry appears to be repeating the same administrative mistake it had made more than a decade ago.They expressed concern that if the Ministry pushes through its reform plan without revision, it will lead to a decline in generic drug sales, reduced capacity to maintain production facilities, decreased investment in new drug R&D, and job losses.He also cautioned that increased use of low-cost APIs, such as those sourced from China, could lead to quality deterioration, greater dependence on originator drugs, and the abandonment of generic launches beyond the 11th product for a given formulation, ultimately disrupting the stable supply of finished drugs.Moreover, if the shortage of generic drugs persists and reliance on originator drugs increases, he projected that the achievement of the National Health Insurance Service's cost-saving goals would become uncertain.Park further stated that the other elements of the reform, such as introducing market-linked actual transaction prices, implementing reforms to the reimbursement adequacy reevaluation system, and establishing periodic drug price adjustment mechanisms, cannot escape criticism for reducing predictability for pharmaceutical companies or being redundant or unreasonable regulations.To address the issues with the Ministry of Health and Welfare's reform plan, Park stressed that policies must be established to use generics as a means to strengthen public access to medical care and pharmaceuticals at reasonable prices, and to create measures where generics play a pivotal role in maintaining health security.With regard to the proposed deduction of the generic pricing rate to the 40% range, he urged the Ministry to engage in sufficient consultation with domestic pharmaceutical companies and consider phased implementation or differentiated pricing rates to ease the impact and improve acceptance.Park stated, “Given that the goal of this reform plan is to transform the domestic pharmaceutical industry ecosystem, revisions are necessary to ensure balanced implementation of both expanded incentives for innovative pharmaceutical companies and regulations increasing the discount rate relative to the benchmark drug price. Before implementing the system, the causes of failure in similar systems must be analyzed, and a flexible policy direction must be set to ensure the system becomes effective.”He added, “To mitigate the shock to the domestic pharmaceutical industry caused by immediate sales declines and ensure the system is accepted, the reform must be implemented gradually. Also, meaningful dialogue with the pharmaceutical industry must take place from the design stage.”“France, UK, Japan: Secured governance by gathering pharmaceutical industry opinions when establishing drug pricing policies”Attorney Kim pointed out that the key issue of the Ministry of Health and Welfare's reform plan was that it was unilaterally established and announced without sufficiently gathering opinions from domestic pharmaceutical companies.To minimize opposition from the pharmaceutical industry and increase acceptance of the Ministry's drug pricing policy, the system should be designed based on two-way communication with the industry, rather than a government-only approach. He criticized that Korea failed to sufficiently guarantee the industry's procedural rights by announcing the plan without consultation.In contrast, major countries such as France, the UK, and Japan have established formal consultation procedures and governance structures to incorporate industry input into drug pricing decisions.France has a framework agreement between CEPS, which handles drug price negotiations, and the pharmaceutical industry association. The UK mandates stakeholder participation and operates official public hearings when reforming drug pricing, payment policies, and systems, centered around NHS England and the Department of Health and Social Care.Japan also operates the process for determining and revising drug prices under the National Health Insurance (NHI) system through the Central Social Insurance Medical Council, an advisory committee to the Ministry of Health, Labour and Welfare.Furthermore, Kim also expressed concern that sharply lowering the generic drug reimbursement rate from the current 53.55% to the 40% range would jeopardize the sustainability of the pharmaceutical and biotech industry, threaten public health security, and trigger job losses.Rather than insisting on a 40% pricing ratio, his point is that the Ministry should redesign a reasonable rate through consultation with industry and defer implementation.Kim further suggested strengthening price incentives for companies contributing to supply stability to enhance the reform’s effectiveness in terms of practicality.He proposed guaranteeing a 68% price level for national essential medicines made with domestically sourced APIs, through base pricing rather than a temporary add-on premium, and applying the price premium immediately when companies switch to in-house APIs, rather than waiting until re-listing.He also recommended excluding innovative medicines or products supplied by three or fewer manufacturers from post-listing price cuts and raising the threshold defining low-priced drugs.Kim said, “The reform plan should be revised and implemented only after sufficient discussion is made over an adequate period, ensuring meaningful protection of industry stakeholders’ procedural rights and genuine consultation with the government.”
- Policy
- GOV “Drug price reform needed for industry growth”
- by Lee, Jeong-Hwan Jan 27, 2026 06:55am
- Director Yeon-sook Kim“Korea has an excessive amount of generic products per ingredient. For example, ingredients with annual market sales under KRW 100 billion have an average of 19 approved products; those under KRW 500 billion have 56 products; and those under KRW 1 trillion have more than 100 on average. Given this reality, we need a serious discussion on how to reform the drug pricing system to create growth momentum for the Korean pharmaceutical industry to reach a global level.”Yeon-sook Kim, Director of the Pharmaceutical Benefits Division at the Ministry of Health and Welfare, repeatedly emphasized that the objective of the drug pricing reform is not to reduce National Health Insurance spending, but to encourage new drug development, secure cost recovery for withdrawal-prevention and essential medicines, and strengthen patient access.She expressed that the domestic pharmaceutical industry's claim that the Ministry of Health and Welfare brought up drug price reductions to save NHIS funds is partly based on misunderstanding, urging understanding that the policy goal is a structural reform of the drug pricing system to spur innovation in the pharmaceutical and biotech industries.In particular, Kim pointed out that Korea has an excessively high number of generic products per ingredient and stressed the need for reform of the generic pricing system to stimulate industrial growth.At a policy National Assembly policy forum on the drug pricing system reform held on the 26th, Kim said, “We designed the reform plan with a sense of crisis and concern that the current drug pricing system has reached its limits, unable to guarantee the supply of essential medicines to the public, let alone new drugs.”Kim emphasized that this drug pricing system reform should serve as an opportunity to strengthen patient access to treatments, enhance the stable supply of essential medicines, and boost the innovation capacity of the pharmaceutical industry.In other words, the goal of this drug pricing policy is not merely a cost-cutting overhaul, but rather a fundamental restructuring and improvement of the pharmaceutical industry's foundation.Kim also expressed pride in Korea’s high level of generic self-sufficiency compared to other countries.However, she acknowledged that the current situation, where an excessive number of generics are approved and marketed for each ingredient, needs to be addressed.Ultimately, she argued that adjusting the number of generics per ingredient through the pricing reform is necessary to create momentum for the Korean pharmaceutical industry’s global expansion.Kim offered no specific response or explanation regarding the postponement or modification of the reform plan's implementation.Kim said, “There was a broad drug-price adjustment policy in 2012, but overall drug costs or the absolute amount itself have not declined since then. Given the increase in chronic disease patients, this is natural. The goal of this drug pricing system reform is not to reduce the proportion of drug costs. The goal is to induce structural reform of the pharmaceutical industry.”Kim concluded, “We must also consider that no comprehensive pricing reform has taken place since 2012. Furthermore, given the reality of an excessive number of domestic generic drug items, we must consider a drug pricing system that enables the domestic pharmaceutical industry to expand globally. We will deliberate on which approach is most effective, achieve the desired results, and reflect the realities of the pharmaceutical industry.”
- Policy
- Cervarix waves white flag to Gardasil… exits KOR mkt
- by Lee, Tak-Sun Jan 26, 2026 01:19pm
- The supply of GlaxoSmithKline’s (GSK) cervical cancer vaccine Cervarix Prefilled Syringe will be discontinued in Korea.The company has decided to withdraw from the Korean market amid a sharp decline in demand. With Cervarix exiting the market, MSD, which holds Gardasil 9, is expected to monopolize this market.The Ministry of Food and Drug Safety announced that GSK reported the discontinuation of Cervarix supply on the 23rd.GSK stated, “Due to a sharp decline in domestic demand, the company has decided to inevitably discontinue supply of Cervarix Prefilled Syringe.”Supplies of Cervarix will continue until July.GSK explained, “Following the supply discontinuation, Cervarix Prefilled Syringe may continue to be administered at medical institutions until the expiration date of existing stock, in accordance with approved vaccination schedules. Currently, MSD’s human papillomavirus vaccine is in supply in Korea.”Currently available human papillomavirus (HPV) vaccines in Korea include MSD Korea’s Gardasil (quadrivalent), Gardasil Prefilled Syringe (quadrivalent), Gardasil 9 (9-valent), Gardasil 9 Prefilled Syringe (9-valent), and GSK’s Cervarix Prefilled Syringe (bivalent).However, MSD has long dominated the market in terms of market share.Based on 2023 import data, Cervarix recorded imports of USD 812,132, compared with USD 12.56 million for Gardasil Prefilled Syringe and USD 44.32 million for Gardasil 9 Prefilled Syringe. This places Cervarix’s import market share at just 1.4%. Analysts attribute this to Cervarix’s lower competitiveness, as it protects against fewer HPV strains than Gardasil.Given Gardasil’s overwhelming market influence, the two products can hardly be considered equal competitors. Gardasil also holds a significantly higher market share in overseas markets. This is why Cervarix withdrew from the U.S. market in 2016 and has since been supplied primarily to developing countries.For the time being, no product appears poised to challenge Gardasil 9 in the Korean market, suggesting MSD's monopolistic structure will persist. Gardasil 9's domestic patent expires next February. This could lead to supply price increases, potentially negatively impacting consumers.In fact, Gardasil 9 drew criticism after raising its supply price for two consecutive years in 2021 and 2022. The current average cost per dose in Korea is reportedly in the low KRW 200,000 range.Meanwhile, competition has begun to emerge in China, where Wantai received approval last year from the National Medical Products Administration (NMPA) for an HPV vaccine, which protects against nine HPV strains like Gardasil 9.
- Policy
- UAE recognizes MFDS as reference body
- by Lee, Tak-Sun Jan 26, 2026 01:19pm
- Going forward, pharmaceutical products seeking registration in the United Arab Emirates (UAE) will be able to do so based solely on Korean regulatory approval.On the 16th, the Ministry of Food and Drug Safety (MFDS, Minister Yu-Kyoung Oh) announced that the Emirates Drug Establishment (EDE), the UAE’s medical products regulatory authority, has officially recognized Korea’s MFDS as an official Reference Regulatory Authority (RRA) in the field of medical products.Established in September 2023, the EDE is the UAE’s regulatory body responsible for the approval and safety management of pharmaceuticals, medical devices, cosmetics, health supplements, and other products within the UAE.This recognition represents a tangible outcome of the practical implementation of the Memorandum of Understanding (MOU) on biohealth cooperation signed and bilateral meetings between the MFDS and EDE following the Korea-UAE summit on November 18 last year. At the request of MFDS Minister Yu-kyoung Oh, the designation was formally conveyed through a letter from Fatima Al Kaabi, Director General of the UAE EDE. The MFDS stated that the move signifies that regulatory cooperation between the two countries has advanced beyond collaboration to a stage of institutional trust.Previously, pharmaceutical companies seeking UAE approval were generally required to obtain authorization from advanced regulatory authorities such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). With MFDS now recognized as a reference authority, companies can apply for UAE approval based solely on Korean MFDS approval. As a result, applicants may benefit from shortened review timelines, simplified regulatory procedures, and exemptions from manufacturing site inspections. This is expected to significantly shorten the time to enter the UAE market and enhance the global competitiveness and credibility of Korean products.Given that the UAE functions as a regulatory and distribution hub for the Middle East and North Africa (MENA) region and the Gulf Cooperation Council (GCC), the recognition is expected to serve as a stepping stone for future entry into the Middle Eastern market for pharmaceuticals and medical devices.This measure is particularly significant because it is based on the Ministry of Food and Drug Safety's (MFDS) full listing as a WHO World-Class Regulatory Authority (WLA) last August and the mutual trust built between the two agencies. The UAE has recognized the MFDS as possessing regulatory capabilities equivalent to those of advanced regulatory authorities, extending this recognition to medical products ranging from pharmaceuticals to biopharmaceuticals and medical devices.Since the establishment of the EDE, the MFDS has pursued multifaceted diplomatic efforts alongside the Embassy of the Republic of Korea in the United Arab Emirates (Chargé d'Affaires Jong-kyung Park) to secure recognition as a reference authority. These efforts included high-level meetings, signing memoranda of understanding, ministerial-level discussions, and bilateral meetings between agency heads.MFDS Minister Yu-kyoung Oh stated, “We are pleased that the UAE’s EDE has officially recognized the MFDS as a reference authority for medical products as a follow-up outcome of the Korea-UAE summit. With MFDS’s regulatory expertise now formally acknowledged in a key Middle Eastern hub country, we will actively support the global expansion of K-Biohealth products, including our pharmaceuticals, medical devices, and cosmetics.”
- Policy
- Yescarta’s second indication passes CDRC review
- by Lee, Tak-Sun Jan 23, 2026 08:39am
- Gilead’s CAR-T therapy Yescarta (axicabtagene ciloleucel) has secured reimbursement criteria, but only for its second indication.The Health Insurance Review and Assessment Service (HIRA) reviewed the reimbursement criteria for oncology drugs, including Yescarta, at the 1st Cancer Disease Review Committee meeting of 2026, which was held on the 21st.Following deliberation, reimbursement criteria were established only for the second indication of Yescarta, ‘Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) after two or more prior systemic therapies’.However, reimbursement criteria were not established for Yescarta’s first indication, ‘treatment of adult patients with DLBCL who relapse or are refractory within 12 months after first-line chemo-immunotherapy.’ Among the new drugs reviewed at the meeting, Yescarta was the only product to secure reimbursement criteria. Amgen’s Imdelltra and Janssen’s Rybrevant failed to establish reimbursement criteria. Rybrevant had drawn attention as a drug used in combination with Yuhan’s Leclaza (Lazertinib).In contrast, all drugs reviewed for reimbursement expansion, rather than new listing, successfully secured reimbursement criteria. These included Jakavi, pomalidomide products, Cabometyx, and Cyramza.Drugs that pass the Cancer Disease Review Committee will now proceed to the Drug Reimbursement Evaluation Committee for assessment of reimbursement adequacy. If approved, they will undergo final procedures through price negotiations with the National Health Insurance Service.
- Policy
- Celltrion drops export permit for FDA-Cleared HIV drug
- by Lee, Tak-Sun Jan 23, 2026 08:39am
- Celltrion has withdrawn the Korean export authorization for an HIV-1 infection treatment drug approved by the U.S. Food and Drug Administration (FDA).The company had pursued overseas HIV treatment markets, including the U.S., through the export authorization, but the move is being interpreted as a change in business strategy. Going forward, Celltrion is expected to focus more heavily on its biosimilar business.According to the Ministry of Food and Drug Safety, Celltrion Pharm withdrew the export license for ‘Temixys Tab 300/300mg (lamivudine/tenofovir disoproxil fumarate)’ as of the 7th. It also withdrew the export approval for the triple-combination HIV drug ‘Telumio Tab (tenofovir disoproxil fumarate, lamivudine, dolutegravir sodium)’.Temixys is a combination drug that combines the active ingredients of GSK's existing original antiviral drug, Zeffix (lamivudine), and Gilead's antiviral drug, ‘Viread (tenofovir)’. It is a product developed by Celltrion for use in combination with other antiretroviral agents to treat HIV-1 infection in adults and children weighing at least 35 kg.Celltrion announced that it received FDA approval for the sale of Temixys on November 16, 2018. This signaled competition with Gilead's ‘Truvada’ in the U.S. HIV treatment market.Prior to FDA approval, Celltrion had obtained export drug authorization from the Ministry of Food and Drug Safety on October 25 of that year, completing preparations for overseas sales.At the time, Celltrion stated it would supply high-quality treatment at a reasonable price compared to the original drug to HIV patients in the U.S. who were unable to access adequate medication due to high drug prices and insurance structures.The company also expressed plans to enter the international procurement market by securing supplier qualification from major global HIV drug procurement organizations, including the World Health Organization (WHO), the Global Fund, USAID, and the United Nations agency UNDP.To this end, the Celltrion Group explained that it had established a new chemical development team within Celltrion and launched a global chemical project.However, the withdrawal of this export license for the AIDS treatment suggests a shift in the company’s business strategy, 7 years after FDA approval. Domestic production of the AIDS treatment will now be discontinued following the authorization withdrawal. Celltrion is expected to focus more intensely on its biosimilar business going forward.
- Policy
- Ozempic, Rezurock, HyalFlex covered from next month
- by Lee, Jeong-Hwan Jan 23, 2026 08:39am
- Novo Nordisk’s type 2 diabetes treatment Ozempic (semaglutide) and Sanofi’s graft-versus-host disease (GVHD) treatment Rezurock (belumosudil) will be covered by Korea’s National Health Insurance starting on the 1st of next month.In addition, new reimbursement standards will be set for Jeil Pharmaceutical’s antibiotic Fetroja (cefiderocol) and Shinpoong Pharmaceutical’s osteoarthritis treatment HyalFlex (hexamethylenediamine cross-linked sodium hyaluronate).On the 22nd, the Ministry of Health and Welfare announced an administrative notice for a partial amendment to the “Detailed Standards and Methods for the Application of Medical Care Benefits (Pharmaceuticals),” which includes the establishment of reimbursement criteria for Ozempic, Rezurock, HyalFlex, and Fetroja.The Ministry plans to gather opinions until the 26th and then submit the agenda for deliberation at the Health Insurance Policy Deliberation Committee meeting on the 29th.For Ozempic Prefilled Pen, new coverage criteria will be established for its use as an adjunct to diet and exercise therapy in combination with oral agents or insulin in adult patients with type 2 diabetes that is not adequately controlled.Coverage for its use as part of the oral combination therapy applies to patients with a glycated hemoglobin (HbA1c) level of 7% or higher despite 2-4 months of combined metformin and sulfonylurea therapy, provided their body mass index (BMI) is 25 kg/m² or higher, or they are unable to use insulin. These patients are allowed reimbursed use of a triple therapy that includes Ozempic.However, if blood glucose is significantly improved with triple therapy, dual therapy with only metformin may also be reimbursed.Its use in combination with insulin (+metformin) is covered when HbA1c remains 7% or higher despite 2-4 months of basal insulin (insulin alone or with metformin) or when HbA1c remains 7% or higher despite combination therapy with Ozempic and metformin (+sulfonylurea).However, objective documentation (treatment history, HbA1c, BMI, etc.) must be submitted at initiation. HbA1c and BMI must be monitored every three months.The coverage period per prescription is up to 4 weeks for the initial 3 months when dosage adjustment is necessary per the approved indications, then up to 3 months thereafter.Rezurock is reimbursed for adults and pediatric patients aged 12 years and older who have failed at least two prior systemic therapies (including ruxolitinib).If ruxolitinib cannot be used due to adverse reactions or contraindications, coverage applies after failure of two or more alternative systemic therapies.If disease progression is absent at the 6-month and 9-month evaluations, and a response is confirmed at the 12-month evaluation, an additional 3 months of treatment is approved with reimbursement.Thereafter, continuous administration is approved upon confirmation of response at each 3-month evaluation. Re-administration is also reimbursed for patients who discontinued due to improvement.However, treatment must be discontinued if GVHD progresses (symptoms worsen or new symptoms appear), unacceptable adverse reactions that render use of Rezurock impossible occur, or a new systemic therapy is initiated after Rezurock.In addition, objective data (such as medical records and blood test results) regarding the target of administration for the initial dose of Rezurock, as well as response evaluations for continued administration or discontinuation, must be submitted.In the case of HyalFlex, coverage applies to patients with knee osteoarthritis of radiographic severity Kellgren-Lawrence grade I–III (mild to moderate).In the case of Fetroja, coverage is applied for complex urinary tract infections and hospital-acquired pneumonia when treatment with carbapenem antibiotics has failed, or when multidrug-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacteriaceae, or carbapenem-resistant Acinetobacter species are confirmed. And a physician’s treatment report must be submitted.For DongKwang Pharm’s Sulbacin Inj and other sulbactam/ampicillin combinations, coverage is approved beyond the approved indications when infection with carbapenem-resistant Acinetobacter baumannii is confirmed. The maximum daily dose is 27g, and the treatment period is within 14 days. Coverage may be approved for periods exceeding 14 days upon reference to the physician’s treatment report.In addition, Hanwha Pharmaceutical's Hepa-Merz Inj and other L-aspartic acid-L-ornithine preparations are covered when symptoms of latent or overt hepatic encephalopathy are present.The general principles for calcium and vitamin D-containing oral combination preparations now include hypoparathyroidism due to procedures such as total thyroidectomy.
