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- 2026-04-21 15:18:26
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- Companies banned from displaying product names on souvenirs
- by Chon, Seung-Hyun Jan 08, 2026 07:31am
- Pharmaceutical companies are now prohibited from displaying product names on promotional material such as pens and notebooks provided to healthcare professionals at product briefing sessions; only the company name may be displayed.According to industry sources on the 7th, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) received Fair Trade Commission approval for the 5th revision of its ‘Fair Competition Code for Pharmaceutical Transactions’ and ‘Detailed Operational Standards for the Fair Competition Code.Among the newly added provisions, the scope of promotional items provided to healthcare professionals has been more clearly restricted.Previously, during product briefings conducted during visits to individual medical institutions, pharmaceutical companies were permitted to provide healthcare professionals with food and beverages, as well as low-value promotional items bearing either the company name or product name.Under the revised rules, companies are now allowed to provide pens and notebooks bearing only the company name strictly for the purpose of delivering medical and pharmaceutical information at on-site briefings. Product names are explicitly prohibited from being printed on these items. Additionally, commemorative gifts may not be provided, and the combined value of the pens and notebooks must fall within the scope of ‘commemorative gifts valued at KRW 50,000 or less’ as specified in the scope of economic benefits permitted under the Enforcement Rules of the Pharmaceutical Affairs Act.The revised code also introduces a new requirement mandating that pharmaceutical companies prepare and disclose an expenditure report detailing economic benefits provided to pharmacists, Korean medicine pharmacists, medical professionals, founders of medical institutions, or employees of medical institutions within 3 months after the end of each fiscal year. Companies must retain the expenditure report, related accounting records, and supporting documentation for 5 years.The definition of pharmaceutical sales promoters has also been expanded. In addition to pharmaceutical suppliers as defined under the Pharmaceutical Affairs Act (i.e., marketing authorization holders, importers, and wholesalers), the scope now explicitly includes “entities entrusted with pharmaceutical sales promotion and those re-entrusted by them.” This clarification means that CSOs (Contract Sales Organizations) acting on behalf of pharmaceutical companies or wholesalers are also subject to the Fair Competition Code's regulations on promotional activities.The revised code also newly stipulates that when pharmaceutical companies support domestic academic conferences or international academic conferences held in Korea, they must not provide any additional financial or in-kind benefits related to the same conference, such as donations, food and beverage offerings, booth rentals, or advertising.New sanctions have also been introduced for companies found to have illegally supported academic conferences.Under the revised provisions, if it is confirmed through a court ruling, administrative action, or investigation by KPBMA that a pharmaceutical company supported the hosting or operation of an academic conference for improper purposes, the Association is prohibited from approving that company’s support for any academic conference hosting or operation for a period of two years from the date the fact of supporting the hosting or operation for improper purposes is confirmed.
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- Prescription drug approvals·BE testing slowing down
- by Chon, Seung-Hyun Jan 08, 2026 07:31am
- The entries of pharmaceutical companies into the prescription drug market continued to slow last year. Approval numbers for new products have dropped by more than 80% compared to six years ago, when generic approvals were at their peak. Creating new revenue streams has become increasingly difficult due to tightened regulatory hurdles, such as restrictions on joint development and the implementation of a tiered drug pricing system. The number of bioequivalence trial approvals related to generic development continues to decline. Concerns are arising that upcoming pricing reforms next year, which will lower generic prices further, may completely extinguish the drive for pharmaceutical companies to enter new markets.Number of prescription drug approvals dropped 82% compared to 6 years ago...generic launch slowed down due to strengthened regulations of approvals and drug pricingAccording to data released by the Ministry of Food and Drug Safety (MFDS) on January 6, 747 prescription drugs were approved last year. There is a 29% increase from the 579 approvals in 2024, but this is an 18% decrease compared to the 915 approvals in 2023.The number of prescription approvals dropped by 33% over the past three years, from 1,118 approvals recorded in 2022.The downward trend has continued since approvals fell 38% from 4,195 in 2019 to 2,616 in 2020. Comparing last year's figures to 2019, the volume of prescription drug approvals has diminished by 82% in just six years.Number of prescription drug approvals by month (unit: number, source: MFDS)Industry analysts believe this slowdown in new generic entries has become solidified due to shifts in pricing and approval systems.Since July 2020, a tiered pricing system has been in implemented, where the ceiling price decreases the later a product is listed for reimbursement. If more than 20 generics of a specific ingredient are already listed, new entries can only receive a ceiling price as low as 85% of the existing lowest price. Furthermore, unless a pharmaceutical company develops the generic internally and conducts its own bioequivalence trials, the price drops significantly. This structure has led to a sharp decrease in approvals for generics that rely on contracted manufacturing.Higher regulatory approval barriers have contributed to diminished drive to market entries. Following the implementation of reform to the Pharmaceutical Affairs Act in July 2021, the number of incrementally modified drugs and generics that can be approved based on a single clinical trial has been limited. The new regulation, the so-called '1+3' rule, limits the number of incrementally modified drugs and generics that can be approved based on a single clinical trial. Specifically, a company that conducts its own trial can only share its data with three other products. Previously, multiple companies could receive approval for 'consigned generics' using the same data set. This regulation effectively made it impossible for 'unlimited generic replication.'The number of prescription drug approvals has shown robust growth since 2018, followed by a steady decline after 2020.In 2018, 1,562 prescription drugs were approved, averaging 130 per month. This figure surged more than twofold in 2019 to 4,195 approvals, or an average of 350 per month. In May 2019 alone, the number of approvals reached 584.From October 2018 to July 2020, over 100 prescription drugs were released every month. However, in August 2020, for the first time in 23 months, monthly approvals fell below 100. Following the approval of 216 items in January 2023, the monthly figure has remained below 100 for nearly three years, with the sole exception of July last year, when 118 approvals were recorded.The surge in 2019 and 2020 was attributed by the government’s movement toward stricter regulations. In 2018, 175 hypertension treatments containing the active ingredient valsartan were banned due to excessive impurities. In response, the MOHW and the MFDS formed a 'consultative body to improve the generic drug system' and limit the oversaturation of generics.As the government showed plans for these regulatory tightening measures, pharmaceutical companies moved ahead to secure generic product approvals, leading to a temporary spike. Since the actual implementation of these institutional reforms, the momentum for new market entries has slowed significantly.Bioequivalence trial approvals down 61% from 4 years ago…diminished new entries of generics·underlying effects of drug pricing re-evaluationRecent attempts to conduct bioequivalence trials for generic market entry have also stagnant.Last year, the number of bioequivalence trial plan approvals stood at 199, unchanged from 197 in 2023. This is a sharp decline from the 505 approvals recorded in 2021. Compared to four years ago, attempts at bioequivalence trials have decreased by 61%.On the surface, new generic entry attempts by pharmaceutical companies have significantly decreased. Industry experts diagnose this as a result of a lack of major generic market openings and the loss of momentum for latecomers following the implementation of the tiered drug pricing system.Number of bioequivalence testing plan approvals by year (unit: number, source: MFDS)The recent decline also reflects an underlying effect from the conclusion of the government's generic price re-evaluation.In June 2020, the Ministry of Health and Welfare (MOHW) announced a plan to re-evaluate pharmaceutical ceiling prices, maintaining existing prices only for generics that submitted proof of internal 'bioequivalence testing' and the use of 'registered drug master files (DMF)' by early 2023.The generic drug price re-evaluation is a policy that applies the new pricing system, which took effect in July 2020, to previously listed generic products. Under the reformed system, a generic product can receive the maximum price only if it meets both criteria, outlining that the manufacturer must conduct its own bioequivalence trial and use registered drug master files (DMFs).To avoid price cuts, pharmaceutical companies launched bioequivalence trials for generics that had already received approval. This strategy involved reformulating existing generics, conducting trials to prove equivalence, and obtaining modified approvals to maintain their current pricing. A common tactic was to switch from outsourced manufacturing to in-house production, thereby satisfying the 'conducted bioequivalence trial' requirement to evade price reductions.Consequently, approvals for bioequivalence trial plans, which recorded at 259 in 2019, rose by 24.7% to 323 in 2020 following the announcement of the re-evaluation. By 2021, this number doubled to 505 cases in just two years. Analysts suggest that with the conclusion of the price re-evaluation, the unusual phenomenon of conducting trials for already-approved generics has vanished, causing trial approval numbers to return to a downward trend.Pharmaceutical companies have already experienced significant losses due to these re-evaluations. In September 2023, the first round of generic price re-evaluations resulted in price cuts of up to 28.6% for 7,355 items. In March 2024, a second round saw prices for 948 items drop by as much as 27.9%. Additional cuts were also imposed on newly categorized products that require equivalence testing, such as sterile preparations like injectables.Pharmaceutical companies anticipate that another reform of the pricing system this year will further dampen market entry.In the reform scheduled for this July, the calculation base for generic prices is expected to drop from 53.55% of the pre-patent-expiration price of the original drug to the 40% range, with 40%-45% as the most likely target. Mathematically, if the maximum generic price falls from 53.55% to 40%, it represents a 25% deterioration in profitability.Entry barriers to late-stage generics are expected to rise as the government increases penalties for failing to meet maximum price requirements.Under the July 2020 reform, a generic price is reduced by 15% for each criterion not met. If both are not met, the price is cut by 27.75%. Currently, failing one criterion drops the 53.55% base to 45.52%, and failing both drops it to 38.69%.Under the upcoming reform, the reduction rate for failing a criterion will increase from 15% to 20%. If the new base is set at 45%, a generic failing one requirement will drop to 36%, and one failing both will fall to 28.8%. If the base is set at 40%, these figures drop further to 32.0% and 25.9%, respectively. In this scenario, a generic failing one requirement would see its price reduced by 20.9% compared to current levels. A generic failing two requirements would see its price reduced by 25.6%.If the criteria are set to 40% , a generic that relies on contracted manufacturing without conducting its own bioequivalence trial would be capped at 32.0% of the original drug's pre-patent price. This is a 29.7% decrease from the current 45.52%. Compared to the era before the 2020 ceiling price requirements were introduced, generic prices would be cut by more than 40% (from 53.55% to 32.00%). For those failing both requirements, the cap would be 25.6%, a 33.8% drop from the current 38.69%.The drive for latecomers to enter the market is expected to shrink further as the tiered pricing system is strengthened. The MOHW has proposed a plan to apply five percentage-point reductions, starting with the 11th generic entry of the same formulation, a significant tightening from the current 21st-entry regulation. Under the reformed system, this additional price cut measure will trigger much earlier, effectively lowering price standards across the entire generic sector.
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- ‘No intention to manufacture APIs despite incentives’
- by Kim, Jin-Gu Jan 08, 2026 07:31am
- The pharmaceutical industry has assessed that the “supply-stability incentive” system, which is included in the government’s drug pricing reform plan, lacks sufficient appeal to drive actual production expansion.Seven out of ten CEOs of pharmaceutical and biotech companies responded that even if the premium is applied, they have no intention of engaging in active pharmaceutical ingredient (API) production or the manufacture of nationally essential medicines. Industry leaders pointed out that the incentive level is insufficient to offset rising costs and risks, becoming a temporary measure rather than a structural solution.7 in 10 CEOs: “Supply-stability incentive ineffective; no intention to expand production”On the 7th, the ‘Emergency Countermeasure Committee for Pharmaceutical Price System Reform to Promote the Development of the Pharmaceutical and Bio Industry’ (Emergency Committee) released the results of an urgent survey conducted among CEOs of pharmaceutical and biotech companies. Fifty-nine pharmaceutical and biotech companies participated in this survey.When asked if they were willing to produce APIs themselves to receive the ‘supply stability incentive,’ 69.5% (41 companies) responded ‘”no.”Similarly, a majority of respondents expressed reluctance to manufacture national essential medicines using domestically produced APIs, with 59.3% (35 companies) answering “no,” while only 35.6% (21 companies) said “yes.”Negative views also dominated assessments of the eligibility criteria and incentive rates associated with the supply-stability surcharge. 52.5% (31 companies) said the current framework was “not reasonable.”Key reasons cited included: ▲Surcharge levels insufficient to cover costs ▲Need for structural stability measures like permanent price cap increases rather than temporary surcharges ▲ Need to consider expanding incentives even for non-essential medicines when using domestic APIs.The Emergency Committee views that if the supply stability surcharge fails to function as a production incentive, it may also limit the policy goal of securing supply stability. The pharmaceutical industry consistently points out that the uncertainty is too high to justify additional investment solely to meet the incentive eligibility requirements.“Market-linked actual transaction pricing system may intensify non-voluntary price competition”Concerns were also raised regarding the market-linked actual transaction price system.When asked about the potential impact on corporate competition and distribution strategies if the market-linked actual transaction price system is introduced and the incentive payment rate is expanded from the current 20% to 50% (multiple responses allowed), 91.5% of respondents (54 companies) answered that “profitability will deteriorate due to intensified involuntary price competition.”Additionally, many responded that changes in sales and distribution strategies would be inevitable, such as ▲the strengthening of healthcare institutions' unilateral bargaining power due to the expanded incentive payments and ▲the increased use of CSOs.Regarding “Innovation incentives”… “Innovation incentives will decrease in practice” concerns ariseRegarding whether the innovation incentive would provide a meaningful preferential benefit, the most common response was ‘preferential treatment will actually decline’ at 49.2% (29 companies).Companies giving this response cited reasons including: ▲ Not qualifying for innovation criteria, ▲ Benefits dropping to the 40% range after the incentive period ends, resulting in minimal benefit, ▲ Narrowing of eligibility from the previous 68% incentive group to only the top 30% of companies by R&D spending ratio, ▲ Incentives being temporary, with benefits immediately reduced if R&D investment levels change.Regarding the validity of the ‘classification criteria and validity of the innovation preferential rate,’ 72.9% (43 companies) answered “not valid.’Reasons cited included: ▲unreasonable differential application of incentives ▲need to judge innovation criteria based not only on R&D spending ratio but also on the quality of overall research outcomes (e.g., new drug pipelines).As for improvements needed in the current Innovative Pharmaceutical Company designation criteria, respondents suggested including facility investment, venture investment, number of clinical trials, technology transfers, and patent registrations in the calculation of R&D expenditures.Additionally, regarding the appropriate bonus period, 32.2% (19 companies) responded ‘3+3 years’.Policy improvements: flexibility in innovation criteria, funds, and tax supportIn response to an open-ended question on additional government support measures needed beyond the current drug pricing reform to promote R&D investment and innovation across the pharmaceutical and biotech ecosystem, the most frequently cited proposal was greater flexibility in the criteria for designating innovative pharmaceutical companies (25 companies).Additionally, many companies highlighted the need for: ▲Expanding funds and R&D tax credits ▲Supporting investments in manufacturing facilities and quality control ▲Providing preferential treatment for suppliers of essential medicines and exit-prevention drugs, along with support for companies addressing supply instability.Finally, 50 companies opposed the inclusion of generic drugs in the price-volume agreement negotiations.Reasons cited included: ▲Generics already have sufficiently low prices, making further reductions double regulation ▲Expanding generic use already contributes to health insurance cost savings ▲Inconsistency with systems in major overseas countries that only apply such measures to new drugs.
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- Pharmaceutical exports to Venezuela account for 0.02%
- by Kim, Jin-Gu Jan 07, 2026 08:46am
- Korea’s pharmaceutical exports to Venezuela totaled USD 1.53 million (approximately KRW 2.2 billion) last year, leading to projections that the impact of the recent U.S. military operation in Venezuela on Korean drug exports will be limited.According to the Korea Customs Service, on January 6, Korean pharmaceutical exports to Venezuela through November last year amounted to USD 1.526 million. This represents just 0.02% of Korea’s total pharmaceutical exports (USD 7.92788 billion) over the same period.Domestic pharmaceutical exports to Venezuela have fluctuated significantly over the past decade. Export volumes stood at USD 3.25 million in 2016, plummeted to USD 130,000 in 2017, rebounded sharply to USD 5.13 million in 2023, and then fell again to USD 650,000 the following year.Despite these fluctuations, Venezuela’s share of Korea’s total pharmaceutical exports has consistently remained below 0.1%. This is why the impact of the U.S. military operation in Venezuela is expected to be minimal on Korea’s pharmaceutical exports.The assessment is that the geopolitical variables affecting neighboring Latin American countries are also unlikely to have significant ripple effects. Domestic pharmaceutical companies primarily sign bundled regional contracts to supply medicines, covering multiple nearby markets like Colombia, Ecuador, and Peru, rather than exporting to Venezuela on a standalone basis. Under this structure, shortfalls in one country can often be offset by volumes in others, mitigating overall contract risk.However, given that Venezuela was mentioned as a competitive export region for domestic P-CAB class gastroesophageal reflux disease (GERD) treatments alongside neighboring Latin American countries, the possibility that it could act as a mid-to-long-term variable has been raised. Relevant companies are closely monitoring developments.HK Inno.N is aiming to expand its flagship GERD drug K-CAB into 18 Latin American countries, including Venezuela. In 2018, the company signed a finished-product export and distribution agreement with major Latin American pharmaceutical company Laboratorios Carnot, covering Mexico, Venezuela, Colombia, Peru, Chile, Ecuador, Uruguay, Paraguay, Bolivia, the Dominican Republic, Guatemala, Honduras, Nicaragua, Costa Rica, Panama, and El Salvador. Subsequently, in 2022, it added a technology transfer agreement with Eurofarma for Brazil.Onconic Therapeutics has also established a supply structure for its GERD drug Jaqbo, following a technology export agreement with Mexican pharmaceutical company Laboratorios Senosiain, covering 19 Latin American countries, including Venezuela.Daewoong Pharmaceutical is actively pursuing Latin American expansion for its P-CAB drug Fexuclue, aiming for global expansion into 100 countries. The product has already been launched in Mexico, Ecuador, and Chile, with regulatory applications submitted in Brazil and Peru. While no official entry into Venezuela has been announced, a regional strategy encompassing neighboring countries is being considered. Daewoong previously employed a bundled contract strategy with local partners for its botulinum toxin product ‘Nabota’ in Latin America. An industry official stated, “Exports of pharmaceuticals to Venezuela were already limited in scale, and the contract structure was mostly regional agreements. It seems unlikely that this situation will have a direct impact. However, considering the geopolitical risks surrounding the Latin American pharmaceutical market in the mid to long term, companies should review export routes and contract structures.”The United States launched military operations on Venezuela's capital, Caracas, and other locations in the early hours of the 3rd (local time). President Donald Trump announced via Truth Social that they had successfully captured Nicolas Maduro. Regarding the reason for the operation, President Trump stated, “Maduro committed narco-terrorism crimes against Americans, and he will face justice. The United States will govern Venezuela until the regime change, and Maduro will face U.S. judicial proceedings.”
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- Rare cancer drug 'Welireg' faces another reimb hurdle
- by Eo, Yun-Ho Jan 07, 2026 08:46am
- The rare anti-cancer drug 'Welireg' has once again failed to be added to the insurance reimbursement list. This is the third round.MSD Korea submitted a reimbursement application for its Welireg (belzutifan), an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in June of last year. However, the company received a decision of 'reimbursement criteria have not been set' from the final review of the Cancer Drug Review Committee (CDRC), held at the end of 2025.This is the third report of Welireg failing to pass the CDRC review following previous failures in August 2025 and March of last year. Since its domestic approval in May 2023, the drug has remained non-reimbursed for over 2.5 years. Attention is now focused on whether Welireg will be summitted again for listing in 2026.Welireg was designated as an orphan drug in Korea in 2023 for the rare disease indication of von Hippel-Lindau (VHL) disease and received final approval in May of the same year.The specific indications include the treatment of adult patients with VHL disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), where immediate surgery is not required.Welireg works by reducing the transcription and expression of HIF-2α target genes involved in cell proliferation, angiogenesis, and tumor growth.The efficacy of Welireg was demonstrated in the open-label Study 004, which enrolled 61 patients with VHL-associated RCC who had at least one measurable solid tumor localized to the kidney.Enrolled patients also had other VHL-associated tumors, including CNS hemangioblastomas and pancreatic neuroendocrine tumors.The primary efficacy endpoint of the clinical trial was the objective response rate (ORR), measured by radiological assessment using RECIST v1.1 evaluated by an independent review committee. Additional efficacy endpoints included duration of response (DoR) and time to response (TTR).The results showed that Welireg achieved an ORR of 49% in patients with VHL-associated RCC. All responses were partial responses. The median DoR has not yet been reached, and 56% of patients had response persistence for at least 12 months. The median TTR was 8 months.Furthermore, in 24 patients with VHL-associated CNS hemangioblastomas, the ORR was 63%. Within this group, the complete response (CR) rate was 4%, and the partial response (PR) rate was 58%.
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- BD Korea revenue exceeds KRW 300B…record high
- by Hwang, byoung woo Jan 06, 2026 08:25am
- In the first fiscal year following the spin-off of its diabetes business unit, BD (Becton, Dickinson and Company) Korea recorded revenue exceeding KRW 300 billion, rewriting its highest performance to date.Despite selling off a business unit that generated approximately KRW 15 billion in annual revenue, the company continued its expansion, demonstrating the success of its business reorganization through numbers. Analysts believe aggressive M&A activity and the targeting of new markets directly drove this performance.Exceeding revenue of KRW 313.5 billion…record growth gains attentionBased on an analysis of audit reports for the 43rd to 46th fiscal years, BD Korea achieved revenue of KRW 313.5 billion in the 2025 fiscal year (October 1, 2024, to September 30, 2025).This figure represents a 25.1% increase compared to the KRW 250.6 billion recorded in the previous fiscal year (October 1, 2023, to September 30, 2024).Profitability indicators, including operating profit and net income, also showed significant improvement during this period.Operating profit for 2025 reached KRW 13.8 billion, an increase of approximately 41% from the KRW 9.8 billion recorded the previous year. Net income also grew by 25.4% to 10.6 billion KRW, demonstrating the company's qualitative and quantitative growth.In particular, this growth is considered highly significant, as it was achieved after the sale of the diabetes business unit, now called Embecta Korea, in March 2024.BD, founded in the United States in 1897, maintains a broad portfolio that spans traditional medical consumables, such as syringes, to advanced diagnostics, life science research equipment, and drug delivery devices.The Korean subsidiary, BD Korea, has built a robust business structure encompassing not only the hospital and diagnostic markets but also the research and pharmaceutical industries, including flow cytometry, single-cell analysis, and drug delivery devices for biopharmaceuticals.The most direct cause of the revenue jump in 2025 is attributed to aggressive M&A.In early October 2024, BD Korea acquired the 'Advanced Patient Monitoring (APM)' business unit from Edwards Lifesciences Korea for KRW 17.6 billion.According to the audit report, BD Korea recognized approximately KRW 9.8 billion in goodwill through this acquisition. It secured KRW 7.1 billion in inventory assets, significantly strengthening its critical care and operating room solution portfolio.As the APM business unit's revenue in the 2025 fiscal year was fully reflected, it served as a primary driver of overall growth.Expansion of the GLP-1 obesity treatment market and demands for deviseThe strong performance of the Medication Delivery Solutions (MDS) division also contributed positively. The expansion of the GLP-1 obesity treatment market, currently a major topic in the pharmaceutical and biotech industry, is cited as a key contributor.BD Korea's booth at COPHEX 2025Last year, the company showcased the BD Vystra, a disposable pen device optimized for the administration of obesity treatments, and the BD Hylok, a pre-filled syringe for high-viscosity drugs, at major exhibitions such as COPHEX 2025.As the obesity treatment market shifts toward combination products in self-injection formats, the increased adoption of BD’s drug delivery solutions, which meet global standards, has been a key driver of the rising performance.Analysis suggests that the distribution of diagnostic equipment within the Life Sciences (BDB) division also contributed to the revenue increase.The next-generation flow cytometer, BD FACSLyric, achieved 200 units in domestic sales as of June 2025, demonstrating an overwhelming market share in the precision immune analysis market.Furthermore, the company solidified its leadership in the high-value equipment market by installing the 'BD FACSDiscover A8', which integrates real-time single-cell imaging technology, at major research institutions such as Yonsei University and Hallym University.This indicates a sustained increase not only in equipment sales revenue but also in future revenue from reagents and maintenance services.BD Korea plans to strengthen its 'End-to-End' integrated services, supporting the entire process from the early stages of biosimilar development to production, in line with the upcoming large-scale patent expirations of major biopharmaceuticals over the next decade.An industry official stated, "BD Korea has successfully transformed its business structure toward high-growth areas like patient monitoring and obesity treatment devices following the diabetes unit spin-off," and added, "Based on its strengths in the global supply chain and strategic partnerships with domestic pharmaceutical companies, the company's growth trend is expected to persist."
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- 3 new K-biosimilar approvals last year…second-highest
- by Chon, Seung-Hyun Jan 06, 2026 08:25am
- Last year, South Korean biopharmaceutical companies received approval of three new biosimilar products. It was the second-highest annual output following the record-breaking eight approvals in 2024. Samsung Bioepis and Celltrion have seen their follow-up pipelines reach the commercialization stage one after another, while Sam Chun Dang Pharm successfully entered the market with its first biosimilar, expanding the number of domestic biosimilar players to five. Currently, Celltrion and Samsung Bioepis received 11 approved biosimilars each.According to industry sources on the 5th, domestic firms obtained approval from the Ministry of Food and Drug Safety (MFDS) for four new biosimilar products last year. Samsung Bioepis secured two of these approvals, while Sam Chun Dang Pharm obtained one. Samsung Bioepis received approval for Obodence (a biosimilar to Prolia) in April 2025, followed by Xbryk (a biosimilar to Xgeva) in May. Both Prolia and Xgeva were initially developed by Amgen, using the same active ingredient, denosumab, but with different dosing schedules and administration cycles. Prolia is used for treating osteoporosis, whereas Xbryk is indicated for preventing skeletal-related events in patients with bone metastases and for treating giant cell tumors of bone.In September 2025, Sam Chun Dang Pharm's Vgenfli, a biosimilar to Eylea (aflibercept), cleared its final regulatory hurdle. This product is indicated for ophthalmic conditions such as wet age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic macular edema. This marks Sam Chun Dang Pharm's first domestic biosimilar approval, entering a competitive field where Samsung Bioepis and Celltrion had already secured approvals for their respective Eylea biosimilars in 2024.The number of biosimilar approvals received by South Korean pharmaceutical and biotech companies by year (unit: number, source: MFDS)The three biosimilar approvals in 2025 were the second-highest in record. It recorded 9 in 2024, and the previous high was 3 in 2015 and 2022. Beyond new product entries, domestic firms are continuously strengthening their market competitiveness through supplemental formulation approvals.Celltrion obtained approval for an Auto-Injector (AI) formulation of Omlyclo in December 2025. This followed the June 2024 approval of the pre-filled syringe (PFS) version. Omlyclo is a biosimilar to Xolair (omalizumab), used for chronic idiopathic urticaria and asthma. The AI formulation is a unique option not currently offered by the original manufacturer in Korea, designed to enhance treatment accessibility for patients who find it challenging to visit medical institutions.Similarly, Celltrion added two new types of Avtozma (an Actemra biosimilar) in February 2025.Samsung Bioepis received approval for its Eylea biosimilar, Afilivu, in 2024, and introduced a pre-filled syringe version last year.To date, South Korean biopharmaceutical companies have successfully commercialized 27 products across 15 therapeutic areas.Celltrion pioneered this space in 2012 with Remsima and has since secured approvals for biosimilars referencing Herceptin, MabThera, Humira, Avastin, Eylea, Stelara, Xolair, Prolia, Xgeva, and Actemra.Samsung Bioepis began its journey in 2015 with Etoloce (Enbrel biosimilar) and has successfully expanded into areas referencing Remicade, Humira, Herceptin, Avastin, Lucentis, Soliris, Eylea, Stelara, Prolia, and Xgeva.LG Chem and Chong Kun Dang have also made notable entries into the Enbrel, Humira, Nesp, and Lucentis markets.Celltrion and Samsung Bioepis received approval for 11 biosimilars each. Celltrion and Samsung Bioepis account for 85% of the 26 approved products. Recently, traditional pharmaceutical companies have increasingly joined forces with these biosimilar developers for domestic distribution.While Samsung Bioepis initially partnered with MSD Korea, it later transferred rights to Yuhan Corp for several autoimmune treatments. However, in March 2024, Samsung Bioepis established its own internal sales organization for direct distribution. It currently maintains partnerships with Boryung for its oncology portfolio (Samfenet and Onbevzi) and Samils Pharmaceutical for its ophthalmology products. For Obodence, Samsung Bioepis selected Hanmi Pharmaceutical as its marketing partner, sharing domestic sales responsibilities.In 2017, Samsung Bioepis initially selected Daewoong Pharmaceutical as the sales partner for Samfenet but switched the distributor to Boryung in 2021. Immediately following the domestic approval of the Avastin biosimilar Onbevzi in 2021, the company signed an exclusive domestic sales agreement with Boryung. For its ophthalmic disease treatments, Samsung Bioepis chose Samil Pharmaceutical as the sales partner for its Lucentis and Eylea biosimilars.Samsung Bioepis recently selected Hanmi Pharmaceutical as the sales partner for Obodence. Samsung Bioepis acts as the developer responsible for production and supply, while both companies jointly manage domestic marketing and sales activities.Daewoong Pharmaceutical entered into a joint sales and distribution agreement with Celltrion Pharm to begin domestic sales of Celltrion's Prolia biosimilar, Stoboclo. Daewoong Pharmaceutical is conducting joint sales of Stoboclo across general hospitals and clinics nationwide alongside Celltrion Pharm. While Celltrion previously sold its biosimilars in the domestic market exclusively through its affiliate, Celltrion Pharm, Stoboclo is the first product from a pharmaceutical company other than Celltrion Pharm to be distributed in the domestic market. Additionally, Daewoong Pharmaceutical has joined LG Chem's sales efforts for its Humira biosimilar, Xelenka.
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- Chinese API importers outnumber domestic manufacturers in Korea
- by Chon, Seung-Hyun Jan 05, 2026 10:39am
- The number of Chinese active pharmaceutical ingredient (API) suppliers importing APIs into Korea continues to rise. Compared to six years ago, nearly 100 more Chinese companies are now supplying APIs to the Korean market, significantly outnumbering domestic producers. The scale of Chinese API imports has also steadily grown, indicating an expanding influence of Chinese products in the domestic market. In addition, as pharmaceutical companies face price pressure and seek lower-cost APIs, the number of Indian suppliers has also grown substantially.According to the Ministry of Food and Drug Safety on the 3rd, the total number of Chinese API importers in 2024 was recorded at 350. This represents an increase of 19 companies from the 331 recorded in 2023, within just one year.Number of Chinese and Indian API importers and domestic API manufacturers by year (Unit: No. of companies; Source: MFDS)The number of Chinese API importers has shown an upward trend year after year. In 2018, APIs were imported from a total of 254 Chinese companies, meaning 96 new importers have been added over the past six years. Although the number declined from 342 in 2021 to 333 in 2022 and 331 in 2023, it rose again in 2024.As the scale of Chinese API imports continues to grow, the number of newly identified importers is also increasing.The value of Chinese API imports rose from USD 678.09 million in 2018 to USD 816.32 million in 2024, representing a 20.4% increase over six years.Domestic pharmaceutical companies prefer inexpensive imported APIs to reduce costs, leading to a sustained increase in imports from China and diversification of import sources. In 2014, China ranked 6th among domestic drug import sources, but by 2024, it had jumped to 3rd place.The number of Chinese importers now exceeds that of domestic API manufacturers. In 2024, there were 315 domestic API producers, 35 fewer than Chinese importers. While domestic producers were 12 fewer than Chinese importers in 2018 (242 domestic vs. 256 Chinese), the gap widened to 23 in 2024.The volume of Chinese APIs used in the domestic market is comparable to that of domestically produced APIs.In 2024, total API production amounted to KRW 4.4007 trillion. Excluding exports worth USD 2.17314 billion, APIs valued at KRW 1.43 trillion were used in the domestic market, calculated using an average 2024 exchange rate of KRW 1,367 per USD.This calculation indicates that Chinese API used domestically last year amounted to KRW 1.1159 trillion. Considering that Chinese API is cheaper than domestic products, this suggests that domestic companies actually use more Chinese API than domestic API.The number of companies importing active pharmaceutical ingredients from India is also steadily increasing. In 2018, 192 companies imported Indian API, but by 2024, this number had risen to 241, an increase of 49 companies over six years. In 2024, the gap between the number of companies importing Indian API and those producing domestically was only 74.Concerns are spreading that if generic drug prices fall further, the avoidance of relatively expensive domestic APIs will intensify.Under the revised drug pricing system scheduled to take effect this July, the pricing benchmark for generics will drop from 53.55% of the price of the original drug before patent expiration to the 40% range. A setting between 40% and 45% is regarded as most likely. Arithmetically, lowering the maximum generic price from 53.55% to 40% implies a 25% deterioration in profitability.An industry insider stated, “Ongoing drug price-cut policies have significantly expanded efforts to source low-cost APIs from import suppliers in China and India. If the price of generics, a core revenue source for domestic pharmaceutical companies, drops sharply, they will inevitably have to further reduce API costs to cut expenses.”
- Company
- Upcoming JPM 2026…K-bio focuses on 'global big deals'
- by Hwang, byoung woo Jan 05, 2026 10:39am
- The '44th Annual J.P. Morgan Healthcare Conference (JPMHC 2026)', the world's largest investment event, will be held from January 12 to 15 (local time), with major domestic pharmaceutical and biotech companies participating to target the global market.This year's event is expected to focus on the reorganization of global supply chains following the implementation of the U.S. Biosecure Act and innovation in drug development based on Artificial Intelligence (AI).Korea's domestic companies plan to strengthen their status through main track presentations while aiming to derive future technology export results through business meetings.JPMHC 2026 is a place where approximately 500 major global pharmaceutical companies, as well as domestic firms, share new R&D achievements and discuss the future direction of the pharmaceutical and biotech industries. For domestic companies, JPMHC 2026 serves as an opportunity to achieve the major goals of 'technology export' and 'partnership formation'.Samsung Biologics and Celltrion to give main track presentations…focus on CDMO strategiesThe most notable participant is Samsung Biologics. The company has received an official invitation for the 10th consecutive year since 2017 and will take the stage in the Grand Ballroom, where only 25 top-tier companies selected by the hosts are featured.CEO John Rim, serving as the speaker, is expected to officially declare the new CMO brand 'ExellenS'.This branding represents Samsung Biologics' core value '4E (Excellence)' and will emphasize company's outstanding competitiveness in the contract manufacturing (CMO) field.Notably, the presentation is likely to highlight the achievement of exceeding $20 billion (approx. KRW 26 trillion) in cumulative orders last year, the expansion of North American bases through the acquisition of the Rockville, Maryland plant, and the 'Super-Gap' strategy to absorb demand shifting away from Chinese CDMOs following the Biosecure Act.Celltrion will also give a main track presentation to demonstrate the synergies of the integrated entity.CEO Jinseok Seo, the eldest son of Chairman Jungjin Seo, is expected to step forward to announce a digital transformation roadmap that introduces AI platforms into areas of drug development to clinical trials and sales.Furthermore, the company is expected to specify plans for a full-scale entry into the new CDMO business based on its recently secured production facilities in the U.S., declaring its leap from a biosimilar firm to a 'Total Healthcare Company'.[Stock Photos] Samsung Biologics CEO John Rim delivers presentation at the 2025 Annual J.P. Morgan Healthcare Conference.APAC track official invitations…scheduled to participate in JPM week meetingsOfficial invitations for presentations on the Asia-Pacific (APAC) track will include presentations of domestic firms.Alteogen, invited as a presenting company, plans to explore additional export possibilities for its human hyaluronidase (ALT-B4) technology, which converts intravenous (IV) injections into subcutaneous (SC) formulations.D&D Pharmatech also announced its selection as an APAC track presenter, unveiling its goal to expand contact with global investors and pharmaceutical companies.D&D Pharmatech is expected to broaden its reach with multinational firms by emphasizing differentiated convenience during the 'New Obesity Drug' rush, presenting clinical progress and oral formulation technology for GLP-1 class obesity and metabolic disease treatments.Hugel is also known to be planning a presentation on its strategy to expand North American market share for its FDA-approved botulinum toxin 'Letybo' and the synergy of its filler business.Beyond the presentation tracks, the activities of biotechs seeking substantive licensing-out (L/O) contracts through unofficial meetings and showcases during JPM Week are also specified.Onconic Therapeutics stated it will participate after receiving an official invitation for the second consecutive year and plans to hold serial meetings with global pharmaceutical companies, biotechs, and investment institutions.ABL Bio will engage in follow-up discussions regarding its blood-brain barrier (BBB) shuttle platform 'Grabody-B', which previously led to large-scale contracts with GSK (approx. KRW 4.1 trillion) and Eli Lilly (approx. KRW 3.8 trillion). Notably, the company plans to share plans for entering Phase 1 clinical trials for its bispecific antibody ADC pipelines (ABL206, ABL209) currently under development through its independent U.S. firm, 'NEOK Bio'.STCube will put forward encouraging clinical data for its immune checkpoint inhibitor 'Nelmastobart'. Based on data proving the biomarker potential of the target protein BTN1A1, STCube is reportedly planning to discuss detailed business structures with global big pharma predicated on actual adoption.ROKIT Healthcare plans to participate in the 'Biotech Showcase 2026' held during JPM Week to present its AI hyper-personalized organ regeneration platform.STCube CSO Seung-han Yu stated, "Nelmastobart has great potential to become a new immune axis that supplements the limitations of existing immune checkpoint inhibitors," and added, "STCube will continue discussions with global companies centered on the mechanism and clinical data at this year's J.P. Morgan Healthcare Conference."An anonymous domestic industry official stated, "J.P. Morgan Healthcare Conference has become an event for South Korean companies to move beyond simple participation to becoming key partners for business discussions on innovative new drugs. As it is a major event at the start of the year, we expect achievements through active meetings during the event."
- Company
- Reimb talks for GVHD drug Rezurock extend into the New Year
- by Eo, Yun-Ho Jan 05, 2026 10:39am
- The graft-versus-host disease (GVHD) treatment Rezurock has stalled at the final stage on its path toward reimbursement listing in Korea.Sanofi Korea and the National Health Insurance Service (NHIS) failed to conclude price negotiations for the ROCK2 inhibitor Rezurock (belumosudil) by the end-of-year deadline and have entered extended negotiations. As a result, reimbursement discussions have carried over into the beginning of this year.Accordingly, it remains to be seen whether Sanofi can complete the listing process in 2026.Rezurock, which was granted accelerated approval from the U.S. Food and Drug Administration (FDA), was approved in Korea in August 2024 and launched as a non-reimbursed product in November. Its key feature is the selective inhibition of ROCK2, a novel mechanism targeting the inflammatory response and fibrosis process in chronic graft-versus-host disease (cGVHD).Chronic GVHD is a complication that occurs in approximately half of patients who receive allogeneic hematopoietic stem cell transplantation. While the patient population may be small due to the disease's nature, it affects half of transplant recipients and is a severe, life-threatening condition requiring essential treatment.Graft-versus-host disease is the leading cause of death in hematologic malignancy patients, accounting for 37.8% of deaths excluding relapse. The problem is that as hematopoietic stem cell transplants increase annually in Korea (1,794 cases in 2023), treating chronic GVHD is becoming increasingly important. Among transplant patients, 42% experience chronic GVHD within an average of 3 years, and 66% have already experienced acute GVHD.However, a significant treatment gap remains. Steroids, recommended as first-line therapy in both domestic and international treatment guidelines, are not suitable for long-term use. Prolonged steroid therapy can cause Cushing’s syndrome, which causes various systemic side effects when used for extended periods, including osteoporosis, joint necrosis, organ failure, hyperlipidemia, gastrointestinal disorders, and growth retardation.While 96% of patients with chronic GVHD receive steroids as first-line therapy, 70% require second-line treatment, and as many as 50% ultimately need third-line therapy. When second-line therapy fails, patients are left to be treated with a combination of steroids and immunomodulators due to a lack of effective third-line options.Furthermore, 97% of GVHD patients treated with steroids experience at least one complication, with infection (79.5%) being the most common. Systemic, multiple symptoms significantly impair patients' quality of life, and host reactions occurring in the lungs or liver are particularly fatal.Against this backdrop, attention is focused on whether Rezurock, if granted reimbursement, can establish itself as a new treatment option.Meanwhile, in clinical trials involving patients who had failed two or more lines of systemic therapy, Rezurock demonstrated a high overall response rate (ORR) of 75%, confirming superior efficacy over existing treatments. Notably, it showed response rates of 71%, 39%, and 26% in the joints, liver, and lungs, respectively—areas where improvement is difficult with conventional therapies.Professor Hee Je Kim, Head of the Department of Hematology at Seoul St. Mary’s Hospital, said, “In 42% of patients with chronic graft-versus-host disease, symptoms occur at multiple sites throughout the body, significantly lowering quality of life. Host reactions occurring in the lungs and liver, in particular, can have a fatal impact on blood cancer patients, making effective management therapies urgently needed.”
