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- 2026-01-24 06:17:29
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- 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- Celltrion has withdrawn the Korean export authorization for an HIV-1 infection treatment drug approved by the U.S. Food and Drug Administration (FDA).The company had pursued overseas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.
- Company
- Pharma in Hyangnam "Unstable employment cannot yield good medicine production"
- by Chon, Seung-Hyun Jan 23, 2026 08:39am
- Landscape of Hyangnam Pharmaceutical ComplexThe pharmaceutical industry gathered at the Hyangnam Pharmaceutical Complex to appeal for a halt to the government's drug price reduction plans. Workers at the complex, where many small and mid-sized pharmaceutical companies are located, expressed fears of job instability, and the possibility of future labor struggles was raised.The "Emergency Response Committee for Drug Price System Reform for the Development of the Pharmaceutical and Biotech Industry" (the Committee), composed of major industry organizations, held a labor-management meeting on the 22nd at the Hyangnam Pharmaceutical Complex in Hwaseong, Gyeonggi Province. The Committee requested a reconsideration of the government's reform. The committee is consisted of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), the Korea Biomedicine Industry Association, the Korea Pharmaceutical Traders Association, the Korea Drug Research Association, and the Korea Pharmaceutical Industry Cooperative.The event was organized for the Committee and the labor-management of the Hyangnam complex to review the risks and impact that the reform plan, which includes large-scale price cuts, would have on the industry and production sites.The event's participants warned, "The large-scale drug price cuts pushed by the government are a declaration of abandonment of the future of the domestic pharmaceutical industry, run counter to the demand of these days for job stability, and collapse the national health safety net."In November last year, the MOHW reported to the Health Insurance Policy Review Committee its plan to lower the price calculation rate for generics and patent-expired drugs from 53.55% to around 40%. The reform is scheduled to be finalized by the Health Insurance Policy Review Committee in February and implemented in July. A month after a press conference held at the KPBMA in Seocho-gu on the 22nd of last month, the pharmaceutical industry once again publicly stated dissatisfaction against the government.The "Emergency Response Committee for Drug Price System Reform for the Development of the Pharmaceutical and Biotech Industry" (the Committee), composed of major industry organizations, held a labor-management meeting on the 22nd at the Hyangnam Pharmaceutical Complex in Hwaseong, Gyeonggi Province. Participants stated, "If the government's reform is implemented as is, it will result in the virtual collapse of the domestic pharmaceutical industry and lead to fatal consequences that jeopardize the health and lives of the public." Hyangnam Pharmaceutical Complex is Korea's largest pharmaceutical production hub, housing 39 business sites from 36 companies.Attendees unanimously agreed that rapid price cuts could deal a severe blow to the entire industry, including job instability, a contraction in R&D investment, and a weakened production base.Participants stated, "If rapid and unprecedented price cuts are implemented, the damage will be concentrated on domestic pharmaceutical companies, including those in Hyangnam, making a loss of up to KRW 3.6 trillion." The industry fears that deteriorating profitability will hinder investment in facilities for quality innovation, infrastructure improvements, and R&D.Oh Sang-jun, Chairman of the Southern Gyeonggi branch of the Chemical Workers' Union under the Federation of Korean Trade Unions (FKTU), voiced his opinion, saying, "Workers may fear job instability due to the government's price cuts. If employment is unstable, good medicine cannot be produced. The government should stop pushing unilaterally and instead consult with pharmaceutical workers to implement an effective drug pricing policy. If necessary, we will resort to struggle."Labor and management representatives from the five organizations in the Committee predicted that more than 10% of the industry's 120,000 workers would inevitably face unemployment. They also pointed out that a contraction in the production of low-profit essential medicines and domestic ethical drugs would ultimately increase reliance on expensive imported drugs, causing serious problems for public health.The labor-management representatives emphasized, "Stop the unilateral push for drug price cuts and guarantee job stability in the domestic pharmaceutical industry," and added, "Officials in charge of healthcare safety should actively foster the industry." Officials from companies in the Hyangnam complex also repeatedly highlighted the side effects.Wonsuk Lee, CEO of Daehan Nupharm, urged, "The reform plan is becoming a profitability shock to small and mid-sized domestic pharmaceutical companies, highly dependent on generics. Small businesses will be unable to handle even the fixed costs for facility investment and quality control. Before pushing an unreasonable plan that ignores the industry's reality, please prepare a reasonable alternative through communication."Lee Deok-hee, Chairman of the Il-dong Pharmaceutical labor union, said, "We have had the unfortunate experience of conducting restructuring due to liquidity limits while continuously making bold investments of 20% of sales to grow future competitiveness," and added, "Price cuts will lead to permanent workers becoming temporary workers and indirect employment leading to dismissals, which could greatly shake the job stability and the very existence of the pharmaceutical industry."On this day, the Medicine and Cosmetics Division of the National Federation of Chemical Workers' Unions under the FKTU issued a statement calling for a "full reconsideration of the drug price system reform and the protection of pharmaceutical jobs."The Medicine and Cosmetics Division urged: ▲reconsideration of the reform, ▲the establishment of a social discussion body involving pharmaceutical workers and unions, and ▲the preparation of measures to protect jobs and ensure employment stability.Lee Dong-in, Executive Secretary of the division, suggested the possibility of a struggle, stating, "We will respond strongly against job instability and restructuring caused by the reform," and added, "We will inform the public of the voices of pharmaceutical workers through various means and continuously raise issues regarding the reform plan."Yunhong Noh, President of the KPBMA, argued, "If the reform is forced through in its original form, the industrial foundation will collapse, and the production of essential medicines will contract. Hyangnam, which is home to small- and mid-sized companies, could face job instability and economic contraction due to changes in the business environment," and "A policy that ignores the voices of the industrial field can never succeed."Cho Yong-jun, Chairman of the Korea Pharmaceutical Industry Cooperative, appealed, "The generic drug price reform plan could pose serious business risks to small and mid-sized pharmaceutical companies," and added, "Rather than a unilateral cut, a phased approach is needed after analyzing the practical impact on employment and investment. Rapid change destroys even the best policy's ecosystem. Companies should be allowed enough time to improve their system."
- 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.
- Company
- 'Drug pricing reform will improve patient access'
- by Son, Hyung Min Jan 22, 2026 08:22am
- As global pharmaceutical R&D trends rapidly shift toward high-priced anticancer and rare disease therapies, attention is focused on how the government's proposed drug pricing system reform will impact domestic patient access and the competitiveness of the pharmaceutical industry.On the 21st, Dailypharm held a Future Forum at the Catholic University of Korea's Songeui Campus Institute of Biomedical Industry. At the forum, Jaeho Jung, Head of Value and Access at Novartis, presented the perspective of multinational pharmaceutical companies on the proposed drug pricing reform.Jung said, “The reform plan is in line with global R&D trends. If appropriate value-based compensation and faster reimbursement listing are achieved, it will send a positive signal not only for patient access but also for Korea’s R&D ecosystem.”On the 21st, Dailypharm held its 55th Future Forum at the Catholic University of Korea's Songeui Campus Institute of Biomedical Industry.Development of high-cost anticancer drugs and rare disease treatments active... “Current drug pricing and reimbursement systems struggle to accommodate innovation.”Jung first highlighted the scale of clinical development in oncology and rare disease therapies. Currently, oncology accounts for 41% of all global clinical trials, of which 35% involve innovative drugs.The rare disease treatment market is expected to reach KRW 542 trillion by 2023, while rare cancer trials account for 74% of all ongoing rare disease studies.Despite this projected expansion of the high-cost new drug market, securing insurance coverage, which is a core value for patient access in Korea, remains inadequate. Among 460 new drugs approved in major countries from 2012 to 2021, the coverage rate averaged 28% across G20 nations and 29% in OECD countries, while Korea lagged at just 17%.Jung said, “Korea is facing a triple burden of ensuring universal welfare with limited resources, expanding access to new drugs, and guaranteeing patients’ right to treatment. The government has not been idle. The system has been continuously revised since 2007, but it has now reached its limits.”Examining the time required for reimbursement by treatment type, rare disease treatments took 23.6 months, anticancer drugs 31.6 months, and general new drugs 18.3 months. Even after new drug approval, a lengthy period remains before patients really gain reimbursement.At the same time, global R&D trends have driven the rise of antibody-drug conjugates (ADCs), bispecific antibodies, and biologics, many of which now hold multiple indications. Some immuno-oncology drugs have more than 20 approved indications.In response, the government has proposed reforms aimed at improving access to new drugs. These include an indication-based pricing, strengthening value-based drug reimbursement, and shortening the reimbursement listing period for rare diseases. In particular, the reimbursement listing period for rare disease therapies is expected to be reduced from an average of 240 days to within 100 days.Jung assessed, “With the proportion of high-cost new drugs rapidly increasing, it is difficult to guarantee patient access solely with limited national health insurance funds. As more drugs secure multiple indications, an indication-based pricing system is in line with global standards”He added, "The current system focuses on increasing reimbursement rates within the existing framework; it remains finance-centered from a patient access perspective. Although the government’s approach is understandable given budget constraints, the system must be operated with the patients in mind.”“Reform will create synergy, not suppress R&D”Jaeho Jung, Head of Value and Access at Novartis KoreaHe also expressed the view that the drug pricing reform could improve the domestic investment environment.Korean pharmaceutical companies, whose portfolios are largely centered on generics, have repeatedly voiced concerns that the proposed drug pricing reform could significantly stifle R&D.However, Jung emphasized the potential advantage that improved access to new drugs could expand investment by global pharmaceutical companies.He explained that currently, only two global pharmaceutical companies have production facilities in Korea, and attracting global-level R&D centers remains challenging.Jung stated, “Even when reviewing potential sites for our flagship one-shot treatment Kymriah, we received feedback that Korea was not suitable. If the system becomes more predictable and the value of R&D is properly recognized, direct investment and partnerships with Korean companies will expand.”He added, “If drug pricing improves in terms of value recognition and patient access, direct investment by global pharmaceutical companies will increase, as well as partnerships with Korean companies.”“Looking at Boston or New Jersey, which have rapidly emerged as global bioclusters, their R&D centers are well-established. This is because they are clustered together in terms of the collaborative R&D value. Looking at the domestic R&D environment, it feels like everyone is working hard, but individually. If the drug pricing reform system is well-established, I believe synergies will grow further, including joint R&D centers between global and domestic companies.”Furthermore, Jung pointed out that discussions on reimbursing high-value new drugs like ADCs and one-shot gene therapies have repeatedly faced difficulties within the existing framework. “The reform plan has a high potential to contribute to improving patient access, aligning with future global R&D trends.”Jung stated, “Operational execution is as crucial as the system's design. I hope a patient-centered system can take root through continuous dialogue between the government and industry.”
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