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- 2026-03-10 00:56:56
- Policy
- Weighted average price of apixaban falls 24%
- by Jung, Heung-Jun Feb 20, 2026 10:04am
- The weighted average price of apixaban declined by 24% last year, driven by increasing market penetration of generic products competing with the original anticoagulant Eliquis (apixaban) and reductions in reimbursement ceiling prices.Further declines are expected this year as generic competition intensifies, with products such as Chong Kun Dang’s Liquisia and Samjin Pharmaceutical’s Elxaban expanding their market presence.According to the Health Insurance Review & Assessment Service (HIRA)’s 2025 annual weighted average prices by active ingredient data, apixaban’s weighted average price fell from KRW 744 to KRW 566 year-over-year.BMS Pharmaceutical Korea’s Eliquis has been engaged in market share competition with generics since the year before last. Pharmaceutical companies that had withdrawn from the market after losing patent lawsuits relaunched their generics, and last year they launched aggressive market penetration efforts, including voluntary price reductions.Chong Kun Dang’s Liquisia reduced its reimbursement ceiling price from KRW 570 to KRW 567 through a voluntary price cut in October last year. Samjin Pharmaceutical’s Elxaban, expanding its presence in tertiary hospitals, is priced at KRW 550. Boryung’s BRapix also voluntarily reduced its ceiling price from KRW 724 to KRW 549 starting last November.Eliquis itself saw its ceiling price reduced from KRW 745 to KRW 570 last September following the reentry of its generic versions. All in all, the weighted average price of apixaban declined sharply within a single year due to generic relaunches and price adjustments.Despite this decline, apixaban’s weighted average price remains close to Eliquis’s ceiling price. This may indicate that generic penetration, while increasing, is not yet dominant enough to drive deeper price erosion.It also indicates that aggressive low-price bidding to enter tertiary hospitals has not yet occurred. Price management is being well-executed even amid market competition.The extent of further declines in the weighted average price for both the first and second halves of this year will likely be determined by the expansion of generics' market share. The key factor will be changes in market share held by Samjin and Boryung, which are expanding prescriptions using price competitiveness as their weapon.According to pharmaceutical market research firm UBIST, Eliquis sales declined from KRW 77.3 billion in 2023 to KRW 74.2 billion in 2024, representing a 3.9% decrease. The impact of generic re-entry is expected to continue to grow.Prior to market withdrawal following patent litigation losses, apixaban generics held a 24% market share. As of the third quarter of last year, their share stood at around 13% post-relaunch. Therefore, even considering only the previous market share, there remains potential for approximately 11% growth.
- Policy
- Takhzyro to be reimbursed from next month
- by Lee, Jeong-Hwan Feb 20, 2026 10:04am
- Takeda Korea’s hereditary angioedema treatment Takhzyro (lanadelumab) will be newly added to the National Health Insurance reimbursement list starting next month, approximately 5 years after receiving domestic marketing approval.Yuhan’s allergic rhinitis therapy Ryaltris Nasal Spray will also see an expansion of its reimbursement criteria.Currently reimbursed only for adolescents aged 12 and older and adults, Ryaltris’s coverage will be extended to pediatric patients aged 6 to 11.In addition, the reimbursement scope for the rare autoinflammatory disease treatment Kineret Inj (anakinra) will be explicitly revised to include treatment of macrophage activation syndrome (MAS).On the 19th, the Ministry of Health and Welfare (MOHW) issued a pre-announcement of a partial revision to the notification detailing reimbursement standards and application methods for pharmaceutical benefits.Under the revision, the Takhzyro Prefilled Syringe will be newly reimbursed effective March 1.Eligible patients include adolescents aged 12 and older and adults diagnosed with hereditary angioedema (Type 1 or Type 2), confirmed via serum testing for C1-esterase inhibitor deficiency or dysfunction (quantitative or functional), who meet the following conditions.Either they must have experienced attacks requiring emergency treatment (icatibant injection) at least 3 times per month on average over the previous 6 months, despite receiving oral danazol for at least 6 months, or they must have experienced a similar frequency of attacks if danazol could not be administered due to contraindications or adverse effects.After using Takhzyro for 6 months, if the average monthly number of episodes requiring emergency treatment (icatibant injection) has decreased by at least 50% compared to the initial treatment period, an additional 6 months of administration is approved.Subsequent reimbursement will require reassessment every six months, with continued coverage contingent upon maintaining the initial 6-month response level.However, after 6 months from the initial administration date, for patients showing stable disease activity and no adverse effects, self-administration is permitted following appropriate education on the administration method, based on the physician's judgment. Self-injection can be prescribed for up to a 2-month supply.Patients must complete a ‘patient medication diary’ to verify the medication administration period, with healthcare institutions responsible for its oversight.Takhzyro must be prescribed by a specialist with experience treating patients with hereditary angioedema. Objective documentation (medical records, test results, etc.) regarding the patient's eligibility for initial administration and response evaluation for continued administration must be submitted.In the case of the ENT medication Ryaltris Nasal Spray, its reimbursement, which was previously limited to patients aged 12 and older, will be expanded, effective March 1, to include children aged 6 to 11. However, the administration must strictly follow the indicated dosage and administration guidelines.Meanwhile, the reimbursement scope for Kineret Inj will be clarified in accordance with the approval conditions set by the Minister of Food and Drug Safety.Coverage will now include treatment for chronic infantile neurologic cutaneous and articular syndrome (CINCA), cytokine release syndrome (CRS) potentially occurring after CAR-T cell therapy, neurotoxicity syndrome, hemophagocytic lymphohistiocytosis (HLH) following CAR-T cell therapy, Schnitzler syndrome, and macrophage activation syndrome (MAS).
- Policy
- Empagliflozin, linagliptin see sharp price drops amid generic entry
- by Jung, Heung-Jun Feb 20, 2026 10:04am
- The weighted average prices of diabetes drugs empagliflozin and linagliptin plummeted by as much as 34% after patent expiry due to generic penetration.For empagliflozin 10mg, the weighted average price stood at KRW 618 two years ago but fell to KRW 408 last year, reflecting significant downward pressure from generic competition.According to a comparison of the 2025 annual weighted average prices by active ingredient, released by the Health Insurance Review & Assessment Service (HIRA), with 2024 figures, empagliflozin and linagliptin recorded notable price reductions.Statin+ezetimibe combination therapies also posted weighted average price declines of 1–3% across strengths. AI-generated image.Additionally, the weighted average prices of other dyslipidemia combinations, such as atorvastatin + ezetimibe and rosuvastatin + ezetimibe, also decreased slightly. While the reduction rate is lower than that of diabetes drugs, at around 3%, the financial impact remains substantial given the large prescription volumes.The patent expiry of Jardiance triggered a surge of generic launches, significantly reducing empagliflozin’s weighted average price. In 2024, empagliflozin 10mg and 25mg were priced at KRW 618 and KRW 798, respectively, but fell to KRW 408 and KRW 532 last year.Linagliptin followed a similar trajectory after patent expiry of Trajenta, with expanding generic competition driving weighted average price erosion. The weighted average price for linagliptin 5mg fell 23.7%, from KRW 523 to KRW 399.Salt-modified products, including linagliptin besylate, also recorded parallel reductions. The weighted average price, which was KRW 525 in 2024, decreased by 23% to KRW 402 last year.Dyslipidemia combination drugs showed relatively smaller declines. The weighted average prices of statin+ezetimibe combinations decreased slightly.For example, the weighted average price of atorvastatin 80mg + ezetimibe 10mg decreased from KRW 1,387 to KRW 1,340, a 3.4% drop. Rosuvastatin 2.5mg + ezetimibe 10mg decreased from KRW 696 to KRW 670, a 3.7% drop.The statin + ezetimibe market is worth approximately KRW 1.4 trillion, and due to the large volume of prescriptions, even a single-digit percentage decrease results in a significant reduction.Despite the slight decline in the weighted average price, the statin + ezetimibe market continues to grow. This indicates that prescription volumes are increasing sufficiently to offset the price declines.
- Policy
- Will the generic drug price cut be put on hold?
- by Lee, Jeong-Hwan Feb 20, 2026 10:03am
- The Ministry of Health and Welfare (MOHW) has decided to exclude the proposed drug pricing reform plan, which includes price reductions for already listed generics, from the agenda of the Health Insurance Policy Deliberation Subcommittee meeting scheduled for today (20th), drawing attention to the rationale behind the move.With the reform proposal removed from the subcommittee agenda, it is also expected to be excluded from the February HIPDC meeting set for the 25th.Observers suggest the ministry deferred subcommittee review to gather additional industry opinions, following strong opposition from the pharmaceutical industry against the Ministry's plan to significantly lower the generic drug price calculation rate from 53.55% to the 40% range.Originally, the Ministry planned to approve the broad framework of the drug pricing system reform plan at this month's HIPDC meeting, targeting implementation in July this year.However, the Ministry appears to have excluded the drug pricing system reform plan from the February subcommittee agenda to gather additional opinions, following strong opposition to the price reduction policy from an emergency counterresponse committee comprising 5 major organizations - Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), Korea Biomedicine Industry Association (KoBIA), Korea Pharmaceutical Traders Association (KPTA) , Korea Drug Research Association (KDRA), and Korea Pharmaceutical Industry Cooperative (KPICO).As a result, the timeline for subcommittee review of the reform plan is effectively delayed by approximately one month. During this period, the domestic pharmaceutical industry is expected to actively engage in negotiations with the Ministry of Health and Welfare for potential revisions.The industry argues that the Ministry's excessive generic drug price reduction rate undermines investment momentum for new drug R&D, encourages the production of low-quality generics, exacerbates employment instability, and ultimately collapses the pharmaceutical industry.The scale of future conflict surrounding the drug price reduction administration will likely depend on how much and how the Ministry of Health and Welfare accommodates the industry's opinions.A representative from domestic pharmaceutical company A commented, “We understand the Ministry excluded the item from February's deliberation agenda to gather sufficient opinions. Since the implementation date is set for July, the key question is whether the public and private sectors can agree on concrete revisions beyond simply excluding the item.”A representative from domestic pharmaceutical company B said, “Given the pharmaceutical industry's growing resistance, it would have been difficult for the Ministry to unilaterally push through the drug price reduction plan as scheduled. But delaying the deliberation once has little effect in quelling substantial industry backlash. What is needed now is policy action that genuinely reflects on-the-ground realities.”
- Policy
- GOV to boost open innovation in the pharma industry
- by Lee, Jeong-Hwan Feb 13, 2026 08:29am
- The government will support industry growth by linking matching between global biopharma companies and domestic pharmaceutical companies in Korea.The Ministry of Health and Welfare (MOHW) and the Korea Health Industry Development Institute (KHIDI) announced that they are recruiting participating companies for the "2026 Global Leading Company Collaboration Program" to vitalize global open innovation in the pharmaceutical and biotechnology sectors.The MOHW and KHIDI have been promoting this global open-innovation support project to solve significant uncertainties for domestic firms. While Korean companies often lack capital and experience in global drug development and face complex regulatory landscapes across different nations.Previously, various programs that facilitated global companies' selection of outstanding domestic firms have yielded success, such as in technology transfer and transactions. As global leading companies show increasing interest, the project will be integrated into a single unified brand starting this year: "K-BioPharma Next Bridge."Specifically, the global companies will select domestic partners as follows: Roche: 4 companies for the "Korea-Switzerland Bio Pass," AbbVie: 2 companies for the "Biotech Innovator Award," Amgen: 2 companies for the "Golden Ticket," Novo Nordisk: 3 companies for "Partnering Day," MSD: 5 companies for "Partnering Day," AstraZeneca: Selection for "Project Nova" (no limit).The Summary of the "K-BioPharma Next Bridge". Roche: 4 companies for the "Korea-Switzerland Bio Pass," AbbVie: 2 companies for the "Biotech Innovator Award," Amgen: 2 companies for the "Golden Ticket," Novo Nordisk: 3 companies for "Partnering Day," MSD: 5 companies for "Partnering Day," AstraZeneca: Selection for "Project Nova" (no limit).Companies selected for the "K-BioPharma Next Bridge" project will receive various growth opportunities, including R&D support, business consulting, prize money, support for residency at international accelerating centers (such as Basel SIP), and investment matching.Eun-young Jung, Head of the Bureau of Health Industry at the MOHW, stated, "As the achievements of open innovation accumulate, the interest of global companies in Korean firms is rising," and added, "We will continue to expand open innovation with global leading companies to ensure domestic companies with promising technologies can enter the global market and succeed in business."Soon-do Cha, President of KHIDI, added, "We will lay the bridge for domestic companies to reach the global market through various open innovation collaborations, such as joint research, mentoring, and residency support," and added, "We will actively support the global expansion and performance of the Korean pharmaceutical and bio industry."
- Policy
- 253 new diabetes drugs listed in 1 year
- by Jung, Heung-Jun Feb 13, 2026 08:29am
- Diabetes medications accounted for the largest share among drugs newly listed for National Health Insurance reimbursement coverage over the past year.Notably, the mass listing of triple combination therapies is accelerating a market shift centered on these multi-drug combinations that emphasize dosing convenience.Reviewing the HIRA reimbursement list on the 12th shows that new diabetes drug listings (classification code 396) surged from 1,723 to 1,976 items from 1,723 in January last year to 1,976 in January this year, representing an increase of approximately 14%.Among drugs newly covered over the past year, the increase in diabetes medications (classification code 396) is the most noticeable. (AI-generated image)The impact of Jardiance (empagliflozin, Boehringer Ingelheim) patent expiry was significant. Over 200 generics were listed around the expiry date last October and are still being added to the reimbursement list. Empagliflozin combination products, in particular, showed a noticeable increase.Previously, AstraZeneca decided to withdraw Forxiga (dapagliflozin) from the Korean market 2 years ago, generic competition intensified significantly. During that period, Jardiance also expanded its prescription volume by capturing market share vacated by Forxiga.This time, however, the focus shifted as a large number of generics entered Jardiance’s KRW 110 billion market, driving a rapid rise in reimbursed diabetes drug listings.Compared to January last year, the number of triple-combination diabetes drugs doubled. The number increased from 16 items in January last year to 32 items this January. Triple combinations featuring sitagliptin, metformin, and empagliflozin or dapagliflozin became mainstream.Following empagliflozin’s patent expiry, multiple new triple combinations have been introduced. Meanwhile, dapagliflozin-based products are expanding primarily through dose diversification within existing combination portfolios.Although dual combination therapies continue to grow, the segment already includes more than 1,000 products, resulting in intense market competition. Consequently, pharmaceutical companies are increasingly pursuing triple combination products as a competitive strategy. The number of triple-combination drugs entering the reimbursement list is expected to increase further this year.While the clinical rationale centers on multi-mechanism therapy and improved patient adherence, industry observers note that market share defense is also a significant factor driving this trend.Conversely, single-agent drugs like metformin showed a slight decline, further reflecting the market’s transition toward combination-based treatment strategies.
- Policy
- Will the acetaminophen shortage crisis end?
- by Lee, Tak-Sun Feb 12, 2026 06:32am
- AI-generated ImageThe shortage of acetaminophen (AAP)-based fever reducers and pain relievers during COVID-19 highlighted the necessity and urgency of domestic pharmaceutical production, or pharmaceutical localization.Following this crisis, the Ministry of Food and Drug Safety (MFDS) conducted a research project for the stable supply of essential medicines, achieving the complete domestic production of acetaminophen from active pharmaceutical ingredient (API) to finished dosage form.On the 10th, the MFDS approved Corepharm Bio’s ‘Coacet Tab 500mg’ (OTC).This product is an acetaminophen tablet and represents the first approved finished drug using a domestically developed API, which was manufactured by MFC.The Ministry of Food and Drug Safety designated acetaminophen (tablets and syrup) as a national essential drug in November 2023 and included the ingredient in its ‘National Essential Medicines Supply Stabilization Research Program’ to support the development of its manufacturing process control technologies for domestic production.The National Essential Medicines Supply Stabilization Research Program is a KRW 5 billion initiative to develop 10 domestically manufactured essential medicines.For the acetaminophen domestic production project, MFC was selected for the API manufacturing, and Corepharm Bio’s for the finished product.MFC completed development of the acetaminophen API last year and finalized its DMF (Drug Master File) registration. Corepharm Bio subsequently secured regulatory approval for the finished product using this API. Previously, APIs for acetaminophen tablets were entirely dependent on overseas sources.Analysis indicates that domestically produced acetaminophen APIs are more expensive per unit than imported alternatives, which historically made the commercialization of finished products challenging. Nevertheless, Corepharm Bio has completed receiving approval for its finished product and is in preparation for domestic market launch.Industry observers anticipate that finished products using domestic API will require sufficient drug pricing support to ensure a stable supply. Consequently, high pricing for this product is expected to be key to ensuring a stable supply.The Ministry of Health and Welfare decided last year to apply a 68% price premium to national essential medicines manufactured using domestically produced APIs. An industry official stated, “It's difficult to say that the development of domestic APIs will completely resolve supply instability. Continued pricing support and policy incentives are necessary to ensure companies can maintain stable production and supply.”
- Policy
- Alfacalcidol approvals increase with expansion of Prolia biosimilars
- by Lee, Tak-Sun Feb 11, 2026 08:09am
- AI-generated imageAs biosimilars for the osteoporosis treatment ‘Prolia (denosumab)’ continue to emerge, products containing the active ingredient alfacalcidol are also increasing.Denosumab-based osteoporosis therapies have effectively dominated the market due to their strong bone mineral density–enhancing effects and patient convenience, as they are administered via subcutaneous injection once every six months.However, because denosumab carries a risk of hypocalcemia, patients are required to take calcium and vitamin D supplements. As a result, the value of alfacalcidol, an “active form of vitamin D,” has also been increasing.According to the Ministry of Food and Drug Safety (MFDS), seven alfacalcidol products have been approved so far in 2026. As of February 9, a total of 42 alfacalcidol products have been approved, with 27 products (over 60%) receiving approval since 2025.Yuyu Pharma has emerged as a major contract manufacturer for alfacalcidol products. Meanwhile, YS Life Science, which has developed tablet formulations that are easier to swallow than capsules, is also expanding its contract manufacturing business. Notably, all three recently approved products are tablet formulations manufactured by YS Life Science.The recent increase in alfacalcidol product development is closely linked to the expansion of the denosumab biosimilar market. The compound patent for Prolia, which accounts for approximately KRW 1.7 trillion in annual market size in Korea, expired in March 2025.Following the patent expiration, Celltrion and Samsung Bioepis launched biosimilar products last year, and on February 4, HK inno.N received approval for its denosumab biosimilar, Izambia Prefilled Syringe. With the entry of additional biosimilars, the overall market size is expected to continue growing further.Denosumab inhibits osteoclast activity, thereby preventing bone destruction and increasing bone mineral density. It offers improved convenience in administration with a single subcutaneous injection every six months.However, because it strongly suppresses bone resorption, there is concern that it may increase the risk of hypocalcemia, particularly in patients with chronic kidney disease or those undergoing dialysis.In 2024, the U.S. Food and Drug Administration (FDA) added a boxed warning to the Prolia label regarding the increased risk of severe hypocalcemia in patients with advanced chronic kidney disease. This update, based on clinical data, has also been reflected in Korea’s label and indication as well.Accordingly, healthcare providers are advised to monitor patients for signs of hypocalcemia after Prolia administration and to prescribe calcium and vitamin D supplements concurrently.Alfacalcidol is an active form of vitamin D that does not require renal activation, offering the advantage of reduced burden on the kidneys. For this reason, it has been gaining attention as a complementary therapy to Prolia. The indications for alfacalcidol are: ▲ Improvement of symptoms associated with vitamin D metabolism disorders in chronic renal failure, hypoparathyroidism, and vitamin D-resistant rickets/osteomalacia; ▲ Osteoporosis.Looking ahead, alfacalcidol product development is expected to continue increasing through expanded contract manufacturing. An industry source commented, “As an over-the-counter drug, alfacalcidol faces no bioequivalence regulations, making contract manufacturing easy and straightforward. Coupled with the anticipated market expansion due to the emergence of denosumab biosimilars, it is expected to remain popular in the product development market for the foreseeable future.”
- Policy
- Concerns mount over push for 100-day listing of rare disease drugs
- by Jung, Heung-Jun Feb 11, 2026 08:08am
- Concerns are mounting over the government’s plan to list rare disease therapies within 100 days, with critics warning that the absence of concrete post-marketing evaluation measures could ultimately undermine the national health insurance system.Some point to the lack of sufficient social consensus in the drug pricing reform as the fundamental issue, arguing that a formal discussion body involving civil society groups, patient advocacy groups, and experts should be established before it is too late.On the 9th, the Citizens’ Coalition for Economic Justice (CCEJ), the Korean Pharmaceutical Association for a Healthy Society, and the Korea Severe Disease Association held a joint press conference to express their opposition to the fast-track listing of rare disease treatments.Even after the event, Dong-geun Lee, Vice President of the Korean Pharmacists' Association for Healthy Society, repeatedly stressed the problems inherent in pursuing fast-track listing without post-marketing evaluation measures.Lee emphasized, “It makes no sense to push ahead with the fast-track listing without a post-marketing evaluation plan in place. We have already conveyed our concerns, but the Ministry of Health and Welfare appears intent on proceeding according to a predetermined schedule.” He emphasized that post-marketing evaluation measures must be established first before any fast-track listing is pursued.The Korean Pharmacists' Association for a Healthy Society maintains that even if the timing of the drug pricing system reform plan, including expedited listing, is delayed, the potential side effects of the policy must be thoroughly examined.Lee said, “The February Health Insurance Policy Deliberation Committee (HIPDC) decision timeline was also arbitrarily set by the Ministry. Even if the schedule is pushed back, sufficient discussion is necessary. If there is even a draft plan for post-marketing evaluation, it should be disclosed so that meaningful dialogue can take place.”Lee also warned, “To make listing within 100 days possible, verification would have to be bypassed and prices approved as requested. That kind of timeline is only feasible for drugs exempt from negotiation or for generics. But based on what has been announced so far, rare disease therapies would effectively be eligible for listing without any additional hurdles.”Given that rare disease treatments often cost tens to hundreds of millions of won, critics argue that if a large number of previously unlisted products are approved, the additional financial burden could exceed one trillion won. Despite this, they say, the government has yet to present any clear plan for securing the necessary funding.The groups also insist that the results of performance-based evaluations for high-priced drugs should be transparently disclosed to patients. Some rare disease therapies already listed have failed to deliver the expected outcomes, and groups argue that this information must be transparently provided to patients.Lee said, “Although the ministry has met with patient groups, it appears to be merely notifying them of decisions already made and pushing the policy through. More discussion is needed with citizens, patient groups, and experts. Above all, the government must disclose its basic plans for post-marketing evaluation and funding.”The Korean Pharmacists' Association for Healthy Society, CCEJ, and patient groups are also continuing discussions on the effectiveness and potential problems surrounding the reform of the generic drug pricing system, suggesting that criticism of the broader drug pricing overhaul is likely to intensify further.
- Policy
- Opdivo voluntarily recalled due to metal particle contamination concern
- by Lee, Tak-Sun Feb 10, 2026 08:14am
- Opdivo (nivolumab, Ono Pharmaceutical Korea), an immuno-oncology drug used across multiple cancer indications, is being voluntarily recalled due to concerns over potential metallic particle contamination.The recall raises concerns over possible treatment disruptions for cancer patients.According to the Ministry of Food and Drug Safety (MFDS), as of the 6th, Opdivo Inj 20 mg, 100 mg, and 240 mg strengths are being voluntarily recalled after information indicating a risk of foreign matter contamination was identified.The recall was initiated after reports suggested the possible presence of fine metal particles attached to the inner surface of the rubber stopper on Opdivo vials.The company stated, “Opdivo is administered using an in-line filter (0.2–1.2 μm). While the potential for inflammation or metal hypersensitivity reactions is considered limited, we have requested that relevant wholesalers, hospitals, and clinics suspend use of the affected products.”MFDS reported the voluntary recall of the following lots: 8 lots of Opdivo Inj 20 mg (2341FA [2026-02-09], 2342FA [2026-03-15], 2342FB [2026-03-16], 2349FA [2026-10-12], 2448FA [2027-09-25], 2542FA [2028-03-03], 2542FB [2028-03-04], 2542FC [2028-03-04]); 13 lots of Opdivo Inj 100 mg (2342FA [2026-03-09], 2343FA [2026-04-24], 2343FB [2026-04-25], 2345FA [2026-06-08], 2345FB [2026-06-08], 2345FC [2026-06-11], 2443FA [2027-04-21], 2443FB [2027-04-22], 2450FA [2027-11-04], 2450FB [2027-11-04], 2542FA [2028-03-26], 2542FB [2028-03-27], 2545FA [2028-06-01]); and 6 lots of Opdivo Inj 240 mg (2343FA [2026-04-16], 2343FB [2026-04-17], 2343FC [2026-04-18], 2349FA [2026-10-23], 2349FB [2026-10-24], 2544FA [2028-05-21])Opdivo is an immune checkpoint inhibitor (PD-1 inhibitor) that prevents cancer cells from evading immune cells (T cells). It works by binding to the PD-1 receptor on the surface of T cells, blocking its interaction with the PD-L1/L2 ligands on cancer cells. This activates the T cells to attack the cancer cells. It is a fully human IgG4 monoclonal antibody.In Korea, Opdivo is reimbursed for indications including first-line gastric cancer, head and neck cancer, third-line or later relapsed/refractory Hodgkin lymphoma after autologous stem cell transplantation, and renal cell carcinoma in combination with Yervoy (ipilimumab). Reimbursement expansion is also being pursued for first-line non-small cell lung cancer and hepatocellular carcinoma.With increasing clinical use, Opdivo’s annual domestic sales are reported to exceed KRW 100 billion.Given that Opdivo is administered to cancer patients, concerns have been raised that the recall could lead to supply disruptions and treatment gaps. The incident is also expected to impact product trust.
