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- 2026-03-10 05:37:54
- 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."
- Company
- Korean Pharma wins first-instance ruling in patent challenge over Sirturo
- by Kim, Jin-Gu Jan 02, 2026 08:00am
- Generic drugmakers have secured a first-instance victory in a patent dispute surrounding Sirturo (bedaquiline), a treatment for tuberculosis.According to industry sources on the 19th, the Intellectual Property Trial and Appeal Board (IPTAB) ruled in favor of BC World Pharmaceutical and Yungjin Pharm in a passive scope confirmation (non-infringement) trial concerning the composition patent for Sirturo Tab (Patent No. 10-1514700), filed against Janssen. The two companies had submitted the petition in September.With the favorable ruling in the avoidance trial, analysts say BCWorld and Yungjin have moved one step closer to early market entry for generic versions of Sirturo.Three Sirturo Tab patents are listed in the Ministry of Food and Drug Safety's patent directory. The substance patent expired this June. Excluding this, a use patent expiring in December 2026 and a composition patent expiring in December 2027 remain.BC World and Yungjin’s strategy is to avoid the composition patent expiring in 2027 and strategically launch generics early, promptly upon the expiration of the use patent next year.Sirturo is Janssen’s tuberculosis treatment that was approved in 2014. It features a novel mechanism of action that inhibits the energy metabolism of Mycobacterium tuberculosis and is used in the treatment of multidrug-resistant tuberculosis (MDR-TB). The World Health Organization (WHO) recommends Sirturo as one of the standard treatments for MDR-TB.According to the MFDS, Sirturo recorded import sales of USD 4.1 million (approximately KRW 5.7 billion) in 2023. Although the overall market size is relatively small, the drug has become a key target for generic manufacturers due to the lack of suitable alternatives in MDR-TB treatment. Furthermore, given that tuberculosis treatment regimens last nearly a year, the launch of a generic version is expected to enable stable revenue generation.
- Company
- Roche accelerates drug reformulation strategy
- by Son, Hyung Min Jan 02, 2026 07:45am
- Roche is driving a paradigm shift across the oncology field by leading with subcutaneous (SC) formulations.The company is actively pursuing formulation changes for its new drugs, positioning ease of administration as a core competitive advantage. Its R&D competitiveness has been confirmed through multiple SC formulation development achievements across both solid tumors and hematologic malignancies.FDA approves Lunsumio Velo…1-minute administration of bispecific antibodies possibleHematologic cancer therapy Lunsumio2According to industry sources on the 2nd, Roche recently received approval from the U.S. Food and Drug Administration (FDA) for Lunsumio Velo, the SC formulation of the bispecific antibody Lunsumio (mosunetuzumab). The drug is indicated for adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.Lunsumio is the first CD20/CD3 T-cell-engaging bispecific antibody approved for relapsed or refractory follicular lymphoma.The approval was granted under the accelerated approval pathway based on results from the Phase I/II GO29781 study. Full approval will be contingent upon confirmation of clinical benefit in confirmatory trials.With the approval of Lunsumio Velo, convenience in administration has improved markedly. While the intravenous (IV) formulation requires 2–4 hours of infusion, the SC formulation can be administered in approximately 1 minute. Roche explained that this dramatically reduces the time patients spend in the hospital, enabling treatment tailored to individual clinical needs and preferences.In the Phase 1/2 GO29781 study, which formed the basis for this FDA approval, Lunsumio Velo demonstrated meaningful anticancer effects even in patients with third-line or later follicular lymphoma, a group with limited treatment options.Clinical results showed an objective response rate (ORR) of 75% in the Lunsumio Velo treatment group, with 59% achieving complete response (CR). The median duration of response (DOR) among responding patients was 22.4 months.Safety was considered manageable. The most common adverse events included injection-site reactions, fatigue, rash, cytokine release syndrome (CRS), musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients, with most events being Grade 1–2, typically occurring during Cycle 1 and resolving within a median of two days. Grade 3 CRS was reported in only 2.1% of patients.Like the IV formulation, Lunsumio Velo can be administered in the outpatient setting and features a fixed-duration treatment approach. Treatment duration may be as short as six months, differentiating it from therapies that require indefinite administration until disease progression.The IV formulation of Lunsumio has already established itself as the first approved bispecific antibody for third-line or later follicular lymphoma. Roche presented long-term follow-up data for both SC and IV formulations at the American Society of Hematology (ASH) Annual Meeting last year and has submitted these data to regulatory authorities globally, including in Europe. Recently, the European Commission (EC) granted conditional marketing authorization for the Lunsumio SC formulation.Roche is also conducting studies to move Lunsumio Velo into earlier lines of therapy, including combination with Polivy (polatuzumab vedotin) in second-line or later diffuse large B-cell lymphoma (SUNMO study) and combination with lenalidomide in first-line follicular lymphoma (MorningLyte study).From Ocrevus to Tecentriq and Phesgo: Roche expands its SC portfolioRoche has systematically built its SC portfolio by developing and expanding SC formulations for multiple core products.Recently, the SC formulation of the multiple sclerosis treatment ‘Ocrevus (ocrelizumab)’ also entered the domestic market.Roche obtained domestic regulatory approval for Ocrevus SC last month. Ocrevus is a humanized monoclonal antibody that selectively targets CD20-expressing B cells and is classified as a high-efficacy therapy that reduces disease activity and delays long-term disability progression in patients with multiple sclerosis.Compared with the IV formulation, Ocrevus SC reduces administration time to approximately 10 minutes and can be used even in healthcare settings with limited IV infrastructure. The dosing schedule remains unchanged at once every six months, allowing treatment with just two administrations per year—another factor enhancing patient convenience.Roche’s Phesgo, Ocrevus, and TecentriqThe shift to SC formulation is also gaining momentum in the solid tumor field. Roche has already secured SC versions of key oncology products, including the immunotherapy Tecentriq (atezolizumab) and the HER2-positive breast cancer therapy Phesgo (pertuzumab/trastuzumab). In particular, Phesgo has been recognized as a successful case where switching from the existing IV combination therapy to a single SC formulation simultaneously improved administration convenience and operational efficiency in clinical practice.Underpinning this SC transition is Halozyme Therapeutics' ENHANZE drug delivery technology. Roche’s subsidiary Chugai Pharmaceutical secured global rights to use the ENHANZE technology through a partnership with Halozyme in 2022.ENHANZE is a drug-delivery platform that uses recombinant human hyaluronidase (rHuPH20) to convert IV drugs into SC formulations.By temporarily injecting hyaluronic acid within subcutaneous tissue, the technology facilitates drug dispersion, enabling high-dose biologics, previously only available via IV, to be administered as a single SC dose. This allows SC administration within 5 minutes compared with IV formulations, significantly reducing treatment burden on patients while greatly enhancing the efficiency of healthcare providers and the entire hospital system.
- Company
- Celltrion secures '4T sales'…generating profit after merger
- by Hwang, byoung woo Jan 02, 2026 07:43am
- In 2025, Celltrion posted 'record sales' by surpassing KRW 4 trillion in annual revenue and 1 trillion KRW in operating profit.The company successfully eliminated concerns regarding declining profitability after merger with Celltrion Healthcare late-2023. Last year, Celltrion achieved an operating margin of 36%.In 2026, growth is expected to continue based on the expanding sales of new pipelines like Zymfentra and the growth of the CDMO (Contract Development and Manufacturing Organization) business.Steady sales growth, 'Profitability quantum jump' in 2025Reviewing Celltrion's performance over the last two years, 2024 can be viewed as an 'adjustment phase' during which the company absorbed accounting costs related to the merger. 2025 can be seen a 'recovery phase', characterized by sales growth and cost reduction.During an online briefing last November, Chairman Seo Jung-jin expressed confidence, stating, "We have emerged from the long tunnel of merger-related adjustments through the third and fourth quarters."Such statement was validated by the 2025 results, which showed profitability improving at an accelerating pace toward the end of the year.Celltrion's sales and operating profits over 4 years (source: FSS, unit: KRW 100 million). GREEN: sales, ORANGE: operating profitsAccording to preliminary announcement results disclosed on December 31, 2025, Celltrion's Q4 revenue reached KRW 1.2839 trillion with an operating profit of KRW 472.2 billion, yielding an operating margin of 36.8%. This represents a significant year-over-year surge in operating profit.At the time of the merger, Celltrion Healthcare's existing inventory was recorded at market value. In 2024, as this high-cost inventory was recognized as revenue, profit margins were suppressed to single digits.However, as this inventory was depleted during the first half of 2025 and replaced with products manufactured directly by Celltrion at lower costs, the Cost of Goods Sold (COGS) ratio plummeted.Celltrion official said, "With the depletion of high-cost pre-merger inventory and the completion of development cost amortization, which were factors that exerted inevitable pressure on operating profit, combined with titer improvement, operating profit is expected to grow steeply."By Q4 2025, the COGS ratio fell to a tentative 36.1%, a 3 percentage point decrease from the 39% recorded in Q3. Q4 EBITDA is projected to reach KRW 538.9 billion, a record quarterly high.Celltrion analyzes its success to the global stabilization of high-margin new products alongside steady growth in its core portfolio.Despite conservative accounting for market volatility, new products, including Remsima SC (U.S. product name: Zymfentra), Yuflyma, Vegzelma, and Steqeyma, all recorded double-digit growth in Q4. Celltrion's quarterly sales and operating profit over two years (source: FSS, unit: KRW 100 million). PURPLE: sales, ORANGE: operating profitsThese new products are expected to show stark growth, accounting for over 60% of total revenue.Zymfentra is expected to generate even higher revenue in 2026, as the impact of PBM listings and initial marketing investments in early 2025 transitions into full-scale prescription expansion in the second half of the year.Celltrion official said, "For some new products, the timing of their launch was delayed due to factors such as patent settlements for stable product supply, resulting in a somewhat limited effect on annual performance improvement," and added, "From next year, as we expand market share and enter a full-scale profitability enhancement track, we expect a high growth trend in 2026."2026 revenue target of KRW 5.3 trillion…CDMO business in full-scaleCelltrion proposed 2026 revenue target of KRW 5.3 trillion.While Celltrion's 2026 revenue target of 5.3 trillion KRW is slightly lower than previous long-term projections , which once aimed for KRW 7 trillion. The company is showing commitment to crossing the KRW 5 trillion threshold.In 2026, the effects of Zymfentra's inclusion in major U.S. PBM listings will be reflected for a full year. As the company enters a phase where increased prescription volume leads directly to profit, significant revenue growth is expected from Zymfentra as a single item alone.In addition, the company plans to pursue an aggressive bidding 'tender strategy' focused on new products with high net profit, concentrating on substantive growth centered on high-margin product groups rather than expansion of external size through increased supply volume.Furthermore, with a portfolio of 11 biosimilar products completed in major global countries, Celltrion revealed a strategy to accelerate product launches in each country, focusing on new products, while simultaneously reducing the proportion of high-cost products and maximizing the profitability of high-margin product groups.Product photo of ZymfentraCelltrion has a total of 11 products commercialized in the U.S. and Europe. Celltrion aims to expand the number of commercialized products to more than 22 by 2030.Along with this, the company is emphasizing the full-scale launch of the CDMO business as a key to revenue expansion.Previously, to specify its mid-to-long-term CDMO business strategy, Celltrion established Celltrion BioSolutions, a specialized CDMO subsidiary, in December 2024, and in August 2025, its subsidiary Celltrion USA decided to acquire a local company with raw material medicine production facilities in the United States.This is a strategic measure to maintain the framework of the existing CDMO business roadmap while flexibly responding to changes in the external environment, such as U.S. tariff policies, and strengthening responsiveness to global customers.In addition, the company plans to secure multiple new drug product (DP) and drug substance (DS) production facilities in South Korea.Celltrion official said, "In this quarter, to enhance investor predictability and timeliness, we announced our forecast performance for the first time before the end of the quarter by applying conservative assumptions considering market volatility," and added. "From 2026, we will focus on steady growth based on high-margin product groups."
- 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.
- Company
- Contracted generics 94%↓ over 5 years…entries suppressed
- by Chon, Seung-Hyun Jan 02, 2026 07:43am
- New entries of generic drugs have significantly decreased, with the number of items with certified bioequivalence reduced by 86% compared to five years ago. The number of generics approved through the entrustment method without conducting independent bioequivalence testing has dropped by more than 90%. Since the implementation of the tiered drug pricing system and the joint development regulation, new entries of contracted generics have been suppressed.According to the '2025 Food and Drug Statistical Annual Summary' published by the Ministry of Food and Drug Safety on the 27th, there were 333 bioequivalence-certified items last year, a 6.1% decrease from the previous year.Bioequivalence-certified items are products recognized as equivalent to the original drug, and they consist mostly of newly approved generics. Since reaching 2,358 items in 2019, bioequivalence certifications have shown a continuous downward trend, shrinking by 85.9% over the five-year period.The number of bioequivalence testing and contracted generics with certified bioequivalence by year (unit: number, source: MFDS). BLUE: in-house GREEN: contractedThe number of entries for contracted generics approved has dropped. Contracted generics refer to those approved by outsourcing the entire manufacturing process to another company without performing an independent bioequivalence study.Last year, the number of bioequivalence certifications for contracted generics was 139. While this is a slight increase from 136 in 2023, it represents a 93.9% contraction compared to the 2,277 items recorded in 2019.The reduction in contracted generics due to the reorganization of the drug pricing system and the strengthening of approval regulations led to a significant decrease in new entries, which in turn resulted in a decline in the total number of generic approvals.Under the reformed drug pricing system implemented in 2020, a tiered pricing model was introduced where the ceiling price becomes lower the later a drug is listed for reimbursement. If more than 20 generics are already registered for a specific ingredient, the ceiling price for a newly listed item is set at 85% of the existing lowest price. It is analyzed that the motivation for new approvals has been significantly dampened as the drug prices for generics entering the market late have dropped substantially.Starting from July 2021, the revised Pharmaceutical Affairs Act limited the number of incremental transition drugs and generics that can be approved using a single clinical trial. In cases where a product is manufactured using the same site, prescription, and manufacturing method as a pharmaceutical company that conducted its own bioequivalence study, the use of that bioequivalence data is limited to three times. This means that only four generics can be approved per single bioequivalence study.Previously, there were no regulations on the number of contracted generics approved per bioequivalence study, which led to an excessive number of approvals. However, as approvals were limited to a maximum of three contracted generics per study, a reduction in the number of new approvals became inevitable.Contracted generic approvals reached 515 cases in 2017 but surged more than fourfold within two years before turning downward to 1,405 cases in 2020 and 573 cases in 2021. Since 2022, the figure has remained below 200 for three consecutive years.The number of generics approved per bioequivalence study has also decreased significantly. In 2019, the number of generics approved through direct bioequivalence testing was 81, accounting for less than 4% of all bioequivalence-certified items. At that time, approximately 29 generics were approved per single bioequivalence study. However, as the number of contracted generics decreased, the number of generics approved through direct testing exceeded the number of contracted generic approvals in 2023 for the first time in 23 years since 2011.In 2011, the 543 products with completed bioequivalence studies outnumbered the 366 contracted products, but the proportion of contracted products became much larger afterward. Last year as well, the number of generics recognized through direct bioequivalence testing exceeded contracted generics by 55 cases. As of last year, 1.7 generics were approved per bioequivalence study, a 94.1% decrease compared to 2019.The industry anticipates that if the reduction of the generic drug price calculation standard is implemented, new generic entries will be further restricted.The drug pricing system improvement plan reported by the Ministry of Health and Welfare to the Health Insurance Policy Review Committee last month includes lowering the price calculation rate for generics and patent-expired drugs from 53.55% to the 40% range.Under the current drug pricing system, effective since 2012, generics receive a premium of up to 59.5% of the original drug price before patent expiration upon initial listing, which then drops to 53.55% after one year. Patent-expired original drugs are also reduced to 53.55% of their pre-expiration price. The new calculation standard for generic drugs is highly likely to be set between 40% and 45%.As the drug pricing standard was set at 45% from 53.55%, the maximum price for generics is calculated to decrease by 16.0%. If the standard is finalized at 40%, the maximum price reduction rate for generics will increase to 25.3% as the previous KRW 53.55 would drop to KRW 40.
- Company
- US and Japan ease new drug approval reviews
- by Cha, Ji-Hyun Dec 31, 2025 07:49am
- As the global biopharmaceutical market grows rapidly, competition among major countries' regulatory authorities over expedited drug reviews has intensified. As the success or failure of new drug development hinges critically on launch timing, nations are engaging in a ‘speed race’ by shortening review timelines and expanding conditional approvals. While Korea has also moved to streamline approval procedures, experts say additional measures are needed to improve the effectiveness and real-world impact of the system.According to the 2025 Biopharmaceutical Industry Trends Report published by the Korea Biomedicine Industry Association(KoBIA) on the 30th, the global biopharmaceutical market has been growing at a double-digit annual rate and has become the central pillar of the pharmaceutical industry. In 2024, the global biopharmaceutical market reached USD 632.3 billion, representing an annual growth rate of 13.6%, and is projected to grow to USD 974.2 billion by 2028.As the market expands, competition among regulatory authorities worldwide to accelerate their approval timeline has also intensified. Countries are strategically leveraging fast-track review and conditional approval pathways to expedite new drug launches and gain an edge in the global approval race.The United States and Japan are currently at the forefront of expedited review frameworks.First, the U.S. Food and Drug Administration (FDA) is establishing a multi-layered expedited review system, including ▲Fast Track, ▲Breakthrough Therapy, ▲Accelerated Approval, and ▲Priority Review.The Fast Track designation applies to drugs intended to treat serious or life-threatening conditions that address unmet medical needs. Under this program, the FDA provides more frequent communication and guidance from the development stage and allows rolling submission and review of data, minimizing bottlenecks throughout development and review.The Breakthrough Therapy designation is a more advanced program than Fast Track and is granted when a drug demonstrates or is expected to demonstrate a significant clinical improvement over existing treatments in early clinical trials. When this program is applied, the FDA assigns a multidisciplinary review team to provide intensive support across clinical, statistical, and manufacturing aspects, helping applicants to finalize development strategies at an early stage.Accelerated Approval allows early authorization based on surrogate endpoints or interim clinical indicators, without waiting for final clinical results. However, post-marketing confirmatory trials are mandatory upon approval, and the FDA may modify or revoke approval if clinical benefit is not demonstrated in these trials. This clear delineation of post-approval responsibility alongside expedited review is central to the U.S. accelerated approval system.Priority Review that shortens the review period itself after an application is submitted. It directly accelerates the launch timeline of new drugs compared to standard review. It applies to treatments for serious diseases or those expected to yield significant public health benefits.Japan adopts a strategy that directly guarantees corporate profitability. The Pharmaceuticals and Medical Devices Agency (PMDA) supports early approval of innovative drugs primarily through Priority Review and the Sakigake program, while also fostering a regulatory environment that considers the potential for market success post-approval.The Sakigake program is Japan's flagship fast-track review initiative for innovative new drugs for severe diseases that are expected to demonstrate superior clinical benefit over existing treatments. If a drug designated under Sakigake is the first in the world to apply for approval in Japan, the re-examination period can be extended up to 10 years. This effectively guarantees a long-term monopoly status equivalent to a patent, serving as a powerful incentive for global pharmaceutical companies to prioritize Japan as an initial launch market.Rather than focusing solely on speed, Europe emphasizes regulatory differentiation based on the level of uncertainty. The European Medicines Agency (EMA) concurrently operates systems like Conditional Marketing Authorisation, Marketing Authorisation under Exceptional Circumstances, Accelerated Assessment, and the PRIority Medicines (PRIME) program, applying different approval pathways based on a drug's development stage and level of clinical evidence. The Marketing Authorisation under Exceptional Circumstances system acknowledges situations such as rare diseases where confirmatory trials may be impractical even after market entry, distinguishing Europe’s approach from other regions.China is pursuing aggressive regulatory innovation centered on speed, accelerating its rise as a global biopharma powerhouse. The National Medical Products Administration (NMPA) operates multiple fast-track review systems, including Breakthrough Therapy Designation, Conditional Approval, Priority Review, and Special Approval.Among these, the Special Approval system for public health emergencies is designed to initiate acceptance and initial review procedures within 24 hours, making it one of the fastest response systems globally. Priority review timelines have also been shortened significantly, from the standard 200 days to 130 days, reflecting China’s aggressive time-reduction strategy.Korea has introduced expedited review and conditional approval systems in line with global regulatory trends. Through the GIFT (Global Innovative product on Fast Track) program, the Ministry of Food and Drug Safety (MFDS) shortens review timelines for innovative drugs and treatments for serious or rare diseases, while allowing conditional approval before full clinical evidence is accumulated.Under GIFT, the review period is reduced by approximately 25%, from 120 days to 90 days. Additionally, the system has institutionalized rolling review, where approval data is submitted and reviewed in stages, to enhance review efficiency.However, critics argue that Korea’s system still lags behind major countries in practical implementation. To achieve genuine global competitiveness, Korea’s GIFT program may require bold enhancements on par with those in leading jurisdictions. Just as Japan’s Sakigake program offers strong exclusivity incentives for first-in-world applications, Korea also needs to strengthen commercial incentives for companies by guaranteeing exclusivity for a certain period after approval or implementing exceptional drug pricing preferential policies.Expanding the scientific flexibility of regulations and strengthening the expertise and authority of regulatory agencies are also identified as key tasks to enhance the competitiveness of the GIFT system. In areas with urgent unmet medical needs, such as cancer and rare diseases, there is an argument for more active acceptance of surrogate endpoints while shifting the regulatory paradigm toward strengthened post-marketing surveillance and post-approval verification. Analysis also suggests that strengthening the MFDS's bio-specialist workforce and institutionally guaranteeing the discretion and responsibility of reviewers must precede such changes.An industry official commented, “We are now in an era where the quality of regulation directly determines a country’s biopharmaceutical competitiveness. Beyond simply accelerating approval timelines, the GIFT system's effectiveness will only truly increase when a clear commercial reward structure is established that allows for the recovery of the massive R&D costs invested in new drug development.”
- Company
- Boehringer Ingelheim takes legal action over similar trademark to Ofev
- by Kim, Jin-Gu Dec 31, 2025 07:49am
- Boehringer Ingelheim has filed a trademark invalidation trial against Daewoong Pharmaceutical, challenging a trademark it deems similar to its nintedanib-based pulmonary fibrosis treatment ‘Ofev (nintedanib)’.Within the pharmaceutical industry, the move is being interpreted as a strategic effort to protect the original brand and deter follow-on generics, particularly given that the legal action was initiated after the generic product name had already been changed.According to the Intellectual Property Trial and Appeal Board on the 30th, Boehringer Ingelheim filed a petition on the 29th to invalidate the registration of the trademark ‘Ofevia’ held by Daewoong Pharmaceutical.Daewoong applied for the Ofevia trademark in October last year and obtained marketing authorization for the generic in January this year. The trademark was officially registered in November. Following the registration, Boehringer initiated legal action, citing the similarity in pronunciation and spelling to its original product, Ofev.However, Daewoong had already changed the product name to ‘Ofild’ in June of this year. While no product is currently marketed under the Ofevia name, the trademark itself remains registered.Industry observers believe Boehringer’s move reflects a broader strategy to reinforce brand protection and curb potential generic competition. The analysis suggests an intent to invalidate the active trademark, regardless of actual usage, to solidify the original brand's distinctiveness.Furthermore, it is also analyzed that even if Daewoong Pharmaceutical does not use the Ofevia name, the fact that the trademark remains registered could influence the naming choices of future generic entrants. This is interpreted as an aim to prevent the reappearance of similar trademarks at the source.This interpretation is further supported by the fact that Boehringer has not pursued invalidation actions against other approved Ofev generics. Currently, approved Ofev generics include Daewoong Pharmaceutical's Ofild and ▲Yungjin Pharm’s ‘Nintebro,’ ▲Kolon Pharmaceutical's ‘Effidanib.’ ▲Ildong Pharmaceutical's ‘Cuninta.,’ all of which are considered sufficiently distinct from the Ofev brand.Ofev is indicated for ▲ the treatment of idiopathic pulmonary fibrosis, ▲ slowing the decline of lung function in patients with systemic sclerosis–associated interstitial lung disease, and ▲ progressive fibrotic interstitial lung diseases with a progressive phenotype. However, reimbursement coverage in Korea applies only to the latter two indications, excluding idiopathic pulmonary fibrosis. According to the Ministry of Food and Drug Safety, Ofev’s import volume last year was USD 3.57 million (approximately KRW 5.3 billion).Generic companies obtained marketing authorizations around January this year, coinciding with the expiration of Ofev’s substance patent. Following Ofev’s inclusion in the reimbursement list in May this year, generics were launched with reimbursement two months later in July.
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- OTC drugs 8K↓·health functional foods 25K↑ over 10 years
- by Chon, Seung-Hyun Dec 31, 2025 07:49am
- The gap between the number of registered health functional foods and over-the-counter (OTC) drugs in South Korea has widened significantly. Over the past 10 years, health functional foods have more than doubled, and just nine years after overtaking OTC drugs, the number of health functional foods items has reached five times that of OTC products. OTC drugs have decreased to nearly half their previous level over the past 10 years, indicating that the movement to enter the market has been greatly restricted. It was also found that one out of every two approved OTC products has no production record.According to the '2025 Food and Drug Statistical Annual Publication' released by the Ministry of Food and Drug Safety (MFDS) on the 31st, the number of OTC drug items was calculated at 8,630 last year. This is a decrease of 490 items from 9,120 in 2023.The downward trend in the number of domestically approved OTC drug items is continuing. From 16,717 items in 2014, the count has shrunk to nearly half over the course of 10 years. The number of OTC items dropped by 5,797, from 14,175 in 2018 to 8,378 in 2019, and although it recovered to the 10,000 level in 2020, the decline has persisted since 2021. The number of OTC drug items rose by 307, from 8,813 in 2022 to 9,120 the following year, but returned to a downward trend within a year.The number of over-the-counter (OTC) drugs and health functional foods registered in South Korea by year (unit: number, source: MFDS)The report indicates that more products have withdrawn from the domestic OTC market than new ones have entered. In the pharmaceutical market, many products disappear due to safety management systems such as the continuous renewal of product licenses. The requirements of the drug product license renewal system is that drugs approved by health authorities must re-verify their efficacy and safety every five years for the license to be maintained. For many products, if marketability is determined to have declined at the time of expiration, the renewal is abandoned and the product is withdrawn from the market.This is a stark contrast to the continuous annual increase in health functional food.Last year, the number of manufactured health functional food items was 41,896, an increase of 4,622 from the previous year. Over the 10 years since 2014, when there were 16,632 items, the count has increased by 25,264, expanding by approximately 2.5 times.In 2014, health functional foods had 85 fewer items than OTC drugs. In 2015, the number of health functional food items rose to 18,956, overtaking the 14,892 OTC drug items by a margin of 4,064, and the gap has gradually widened since then. Last year, the number of health functional food items was found to be about five times greater than that of OTC drugs.. The gap becomes even larger when considering only those OTC drugs with actual production records. Last year, the number of OTC drugs with production records was 4,631, compared to 4,873 in 2023. This means that about half of the OTC drugs currently maintaining MFDS approval have no production records. The number of OTC items with production records has decreased by 1,444 over the 10 years since 2014, when it was 6,075.Analysis suggests that as the health functional food market size continues to grow and market entry barriers are relatively lower than those for OTC drugs, new entry activities are more active. Last year, the health functional food market was valued at KRW 4.0131 trillion, a 1.9% decrease from the previous year. It has decreased for two consecutive years from KRW 4.1695 trillion in 2022. The industry analyzes that as new entries into the health functional food market have become active and low-price competition has intensified, it has affected the reduction in market size. However, compared to KRW 2.4130 trillion in 2014, the market size has increased by 146.1%, showing rapid growth recently.The health functional food market size and over-the-counter (OTC) drug production size by year (unit: KRW 100 million, source: MFDS)Following the enactment of the Health Functional Food Act in 2003, the health functional food system was implemented. The purpose of introducing the Act was to contribute to the promotion of public health and consumer protection by ensuring the safety and improving the quality of health functional foods and fostering sound distribution and sales. The domestic health functional food market surpassed KRW 1 trillion for the first time in 2010 and exceeded KRW 2 trillion in 2016. The market size grew to the KRW 3 trillion range in 2020 and has remained above KRW 4 trillion since 2021.While the number of OTC drug items continued to decline, production performance showed a brief upward trend.Last year, the production size of OTC drugs was KRW 4.2357 trillion, a 9.9% increase from the previous year. Last year's OTC production amount was the largest in history.The production size of OTC drugs decreased from KRW 3.1779 trillion in 2020 to KRW 3.0692 trillion in 2021 but returned to an upward trend in 2022. In 2022, the OTC production record was KRW 3.5848 trillion, a 16.8% increase from the previous year, and in 2023, it recorded KRW 3.8554 trillion, a 7.5% increase year-on-year. Last year's OTC production scale increased by 38.0% in three years compared to 2021, surpassing KRW 4 trillion for the first time.Analysis suggests that the recent expansion of OTC production records was most heavily influenced by the COVID-19 pandemic and endemic.Since the end of 2021, when hundreds of thousands of COVID-19 cases were reported daily, sales of antipyretics, analgesics, and cold medicines used for symptom relief significantly increased. It is analyzed that the boom in the OTC market has continued as the number of flu and cold patients surged since the transition to the COVID-19 endemic phase in 2023.
