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- 2026-04-21 15:18:31
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- Obesity·COVID-19 drugs change multinational pharma performance
- by Son, Hyung Min Apr 14, 2026 08:53am
- There was no outstanding player. The performance of multinational pharmaceutical companies' Korean subsidiaries last year diverged sharply by product portfolio.While some companies recorded high growth driven by expanded obesity treatments, those that saw sales boosts from COVID-19 showed a clear downward trend in growth following the transition to the endemic phase.According to the Financial Supervisory Service on the 14th, sales by the Korean subsidiaries of 30 major multinational pharmaceutical companies increased by 8.0% from KRW 8.7417 trillion in 2024 to KRW 9.4453 trillion last year. Among the 30 Korean subsidiaries, revenue increased for 24 companies, including Novartis Korea, Novo Nordisk, Sanofi-Aventis Korea, and AstraZeneca Korea.Novartis Korea recorded the highest sales among the Korean subsidiaries of multinational pharmaceutical companies. The company's sales last year amounted to KRW 721.3 billion, up 6.3% from the previous year.In terms of operating profit, Otsuka Korea was the highest. Otsuka Korea recorded an operating profit of KRW 49.9 billion last year, a 6.2% increase from KRW 47.0 billion in 2024.Janssen Vaccine recorded sales of KRW 78.4 billion last year, a sharp 52.7% increase from KRW 51.3 billion in the previous year.However, the company faced changes in terms of business continuity. According to the public disclosure, the management of the parent company of Janssen Vaccine decided to cease business activities in November 2025, and last year's financial statements were prepared on a liquidation basis without applying the going-concern assumption.Accordingly, despite the increase in sales, Janssen Vaccine continues to reflect uncertainty about the continuity of its future business.Sales Trend of Multinational Pharmaceutical Companies' Korean Subsidiaries: (from top) Novartis Korea, Novo Nordisk, Sanofi-Aventis Korea, AstraZeneca Korea, Pfizer, MSD Korea, Merck, Roche Korea, Eli Lilly Korea, Janssen Korea, GSK, Viatris Korea, AbbVie Korea, Boehringer Ingelheim Korea, Bayer Korea, Otsuka Korea, BMS Korea, Amgen Korea, Gilead Sciences Korea, Janssen Vaccine, Lundbeck Korea, Ferring Korea, UCB Korea, Menarini Korea, Ipsen Korea, BeOne Medicines, Teva Handok, Leo Pharma, and Kyowa Kirin Korea.Major shifts with obesity drugs… Explosive growth for Lilly and Novo NordiskCompanies selling obesity drugs posted the highest growth rates.Eli Lilly Korea's sales last year was KRW 482.1 billion, a 193.6% increase from the previous year. Operating profit also surged 259.2%, from KRW 10.3 billion to KRW 37.1 billion. Eli Lilly Korea showed the highest sales growth rate among major multinational companies.Previously, Lilly maintained stable sales with oncology drugs such as 'Verzenio (abemaciclicb)' and 'Cyramza (ramucirumab),' as well as the SGLT-2 inhibitor 'Jardiance (empagliflozin)' and the biological agent 'Taltz (ixekizumab),' but it showed a stagnant trend, recording approximately KRW 200 billion sales from 2021 to 2024.This structure changed completely after the launch of the obesity treatment 'Mounjaro (tirzepatide).' Mounjaro, launched in Korea last August, quickly settled in the market, becoming a core growth pillar in a short period.According to the market research firm IQVIA, Mounjaro surged from KRW 28.4 billion in the third quarter of last year to KRW 187.1 billion in the fourth quarter, surpassing KRW 100 billion in quarterly revenue for a single product. Market presence was expanded by overtaking the competing drug 'Wegovy (semaglutide).'This demand expansion was reflected directly in the financial indicators. Eli Lilly Korea's inventory assets increased by 279.3% from KRW 49.4 billion to KRW 187.3 billion, and cash and cash equivalents also increased by 88.6% from KRW 82.1 billion to KRW 154.8 billion. This reflects both the improvement in cash generation following the revenue expansion and a strategy to preemptively secure volume.Novo Nordisk gained effects from 'Wegovy (semaglutide).' The company's sales increased by 85.6% from KRW 308.5 billion to KRW 613.6 billion, and operating profit also increased by 77.1% from KRW 13.7 billion to KRW 24.2 billion.Novo Nordisk, which had maintained stable growth centered on insulin, hemophilia treatments, and Saxenda, saw its performance structure change completely after the launch of Wegovy.Last year, Wegovy's revenue was KRW 467.0 billion, accounting for more than 70% of the total, creating an unusual structure where a single product led the growth of the legal entity. Every quarter, it showed rapid market dominance, surpassing KRW 100 billion in revenue within one year of its launch.Companies with COVID-19 boost see sales decrease… Kyowa Kirin -80% following business saleCompanies that relied on the special boost from COVID-19 entered a clear phase of negative growth following the transition to the endemic phase.MSD Korea's sales decreased 14.2% from KRW 667.8 billion in 2024 to KRW 573.2 billion last year. During the same period, operating profit decreased 13.0% from KRW 24.9 billion to KRW 21.6 billion.The main reason for the sales decrease was the supply void of the COVID-19 treatment 'Lagevrio (molnupiravir).' MSD Korea explained that the absence of a supply contract with the Korea Disease Control and Prevention Agency last year affected the revenue decrease.In fact, MSD Korea's sales have been highly volatile, driven by demand for COVID-19 treatments. Revenue peaked at KRW 820.4 billion in 2022 when demand reached its peak, but subsequently decreased to KRW 760.9 billion in 2023 and KRW 667.8 billion in 2024 following the endemic transition. Compared with last year's revenue of KRW 573.2 billion, revenue has shrunk by 30.1% over the past three years.While performance decreased due to the revenue shortfall from COVID-19 treatments, MSD Korea is seeking a rebound by reorganizing its portfolio around oncology, vaccines, and rare diseases.Pfizer Korea showed a similar trend. The company's sales decreased 25.2% from KRW 783.7 billion in 2024 to KRW 586.1 billion last year.The company's overall performance shrank as demand for the COVID-19 vaccine 'Comirnaty' and the treatment 'Paxlovid' plummeted. This is the result of reflecting the base effect from the significant decrease in public supply volume, which had surged during the pandemic.Gilead also saw sales decrease 26.8% from KRW 319.8 billion in 2024 to KRW 234.0 billion last year due to the supply void of the COVID-19 treatment 'Veklury.'For Kyowa Kirin Korea, the sales decline continued due to the sale of its business. The company's sales last year amounted to KRW 13.8 billion, a sharp 79.9% decrease from the previous year.Kyowa Kirin Korea sold its Asia-Pacific business unit after conducting a restructuring in Korea in 2024. The company sold its China business to Hong Kong's Winhealth Pharma Group. Kyowa Kirin Korea transferred its promotion and distribution units in major Asian countries, such as Korea and Taiwan, to the pharmaceutical distributor DKSH.In addition, sales decreased slightly for Amgen Korea (-6.2%) and Teva Handok (-3.9%).
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- Final Zemiglo use patent invalidated in Korea
- by Kim, Jin-Gu Apr 13, 2026 09:11am
- The dispute surrounding the use patent for LG Chem’s diabetes treatment Zemiglo (gemigliptin) has ended with a final victory for generic companies. With this ruling, generic companies will be able to launch generic versions of Zemiglo after the substance patent expires in January 2030.Supreme Court issues discontinuance of trial on LG Chem’s appeal… use patent finally invalidatedAccording to the industry sources on the 10th, the Supreme Court issued a discontinuance of trial in the final appeal of the Zemiglo use-patent invalidation case filed by LG Chem against Celltrion Pharm, Dongkoo Bio & Pharma, Daehwa Pharmaceuticals, Jeil Pharmaceutical, and Boryung.A discontinuance of trial means that the Supreme Court affirms a lower court’s ruling without reviewing the merits of the case, having determined that the grounds for the appeal do not meet legal requirements. Consequently, the second-instance ruling, in which LG Chem lost, has been finalized. The use patent for Zemiglo has therefore been invalidated.LG Chem and generic drug companies had been in dispute over the use patent, which expires in October 2039. This patent covers the combined administration of gemigliptin and insulin. Celltrion Pharm and others filed a petition for invalidation in 2023, arguing that the patent lacked inventive step.The Intellectual Property Trial and Appeal Board (first instance) and the Intellectual Property Court (second instance) both ruled in favor of the generic companies. The Supreme Court then reached the same conclusion, putting an end to a legal battle that had lasted nearly 3 years.Impact of the final invalidation ruling… scope-confirmation litigation previously won by LG Chem also heading toward closureThis ruling is expected to influence a separate litigation regarding the scope of rights currently underway concerning the same use patent.Until now, disputes over Zemiglo’s use patent had proceeded along two separate tracks - the ‘invalidity lawsuit’ and the ‘scope of rights confirmation lawsuit.’ While the generic company won both disputes in the first instance, the rulings diverged in the second instance. While the generic drug companies prevailed in the invalidity suit regarding the use patent, the original manufacturer, LG Chem, won the dispute over the scope of rights.Because of those conflicting second-instance rulings, uncertainty grew over the timing of the early generic launch. At the time, there were concerns that if LG Chem ultimately succeeded in defending the patent, a generic launch could be delayed until after 2039.However, the situation has now reversed with the Supreme Court ruling. Legally, once a patent is definitively invalidated, the rights associated with it are deemed to have never existed from the outset. That means the favorable ruling LG Chem obtained in the scope-confirmation litigation loses legal effect, because the patent in question, which served as the basis for comparison, is now interpreted as “non-existent.”From the perspective of generic drug companies, this ruling effectively allows them to bring forward the launch of Zemiglo generics by 9 years, to a date after January 2030, when the substance patent expires. Although Zemiglo has a salt and hydrate patent set to expire in October 2031, generic drug companies have already successfully circumvented it.Zemiglo is LG Chem’s flagship drug. According to market research firm UBIST, the combined prescription sales of the ‘Zemiglo family’, which includes Zemiglo, Zemimet, Zemidapa, and Zemiro, totaled KRW 159.1 billion last year, a 4% increase from the previous year. Among these, Zemiglo alone recorded KRW 41.4 billion in prescription sales, accounting for 26% of the total family product prescriptions.
- Company
- MSD Korea sales 30%↓ in three years
- by Son, Hyung Min Apr 13, 2026 09:11am
- MSD Korea's performance continued to decline due to lower demand for COVID-19 treatments. As sales from treatments that drove performance during the pandemic have rapidly shrunk, existing core products have failed to offset the loss.According to the Financial Supervisory Service's electronic disclosure system on the 13th, MSD Korea's sales decreased by 14.2%, from KRW 667.8 billion in 2024 to KRW 573.2 billion last year. During the same period, operating profit dropped 13.0%, from KRW 24.9 billion to KRW 21.6 billion.MSD Korea Sales Trend by Year (unit: KRW 100 million). MSD Korea's sales decreased by 14.2%, from KRW 667.8 billion in 2024 to KRW 573.2 billion in 2025.The primary reason for the sales decline is the lack of supply of the COVID-19 treatment 'Lagevrio (molnupiravir).' MSD Korea explained that the absence of a supply contract with the Korea Disease Control and Prevention Agency (KDCA) last year affected the sales decrease.In fact, MSD Korea's sales have shown significant volatility, reflecting demand for COVID-19 treatments. Revenue peaked at KRW 820.4 billion in 2022 when demand was the highest, but subsequently decreased to KRW 760.9 billion in 2023 and KRW 667.8 billion in 2024 following the transition to the endemic phase. Compared with last year's sales of KRW 573.2 billion, revenue has shrunk by 30.1% over the past three years.Despite having a strong lineup of major products, including the immunotherapy 'Keytruda (pembrolizumab),' the cervical cancer vaccine 'Gardasil,' and the pneumococcal vaccines 'Vaxneuvance' and 'Capvaxive,' it was not enough to fill the void left by the end of the COVID-19 sales.However, the company continued investing in its Research and Development (R&D).According to data released by MSD Korea, the company invested 78 billion KRW in R&D last year, accounting for approximately 14% of its revenue, and has consistently invested over KRW 70 billion annually for the past five years. Despite the short-term performance decline, the company appears to be continuing its strategic investments to secure a foundation for medium- to long-term growth.New Indications·Pipeline Additions…Seeking a Rebound in PerformanceWhile performance has declined due to the sales void from COVID-19 treatments, MSD Korea is seeking a rebound opportunity by reorganizing its portfolio around oncology, vaccines, and rare diseases.The scope of Keytruda was rapidly expanded this year, with 11 additional indications, including triple-negative breast cancer and endometrial cancer, added to the reimbursement list. Furthermore, reimbursement for combination therapy with 'Padcev (enfortumab vedotin)' in urothelial carcinoma is also imminent.RSV preventive antibody injection 'Enfloncia (clesrovimab)' Keytruda has become a pillar of treatment with expanded reimbursement scope as a standard of care (SOC) across major solid tumors. This treatment has the most indications among drugs authorized in Korea.At the same time, efforts to develop new growth engines for infectious diseases are underway. MSD Korea has applied for the authorization of 'Enfloncia (clesrovimab),' an RSV preventive antibody injection for neonates and infants, and there is talk of possible approval in the second half of this year.Enfloncia is a long-acting monoclonal antibody that, in Phase 2b/3 clinical studies, demonstrated reductions of 60.5% in the occurrence of RSV-related lower respiratory tract infections and 84.3% in the risk of hospitalization.In addition, the reimbursement process for 'Winrevair (sotatercept),' a treatment for pulmonary arterial hypertension (PAH), is accelerating following its inclusion in the pilot project for concurrent authorization, evaluation, and negotiation.Winrevair is the first approved activin signaling inhibitor (ASI) in pulmonary arterial hypertension and offers a new mechanism of action after 20 years. This treatment works by blocking excessive activin signaling. This protein complex promotes cell proliferation in pulmonary arterial vessels, and restores the balance with anti-proliferation signals to induce reverse remodeling, normalizing altered vascular structures.As the impact from the termination of the COVID-19 special demand is being reflected, the expanded reimbursement for major products and the introduction of new drugs are expected to be key drivers of a future performance rebound.
- Company
- AZ launches Tezspire in Korea with expanded indication
- by Son, Hyung Min Apr 10, 2026 08:27am
- AstraZeneca Korea (CEO Eldana Sauran) announced on the 8th the domestic launch of Tezspire (tezepelumab) as an add-on maintenance treatment for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).With this domestic launch, Tezspire has simultaneously expanded its indication to include its use as an add-on maintenance treatment for adults with inadequately controlled CRSwNP, broadening its use as an anti-TSLP (Thymic Stromal Lymphopoietin) treatment option for severe asthma to CRSwNP.TSLP is a driver of multiple inflammatory responses and is expressed at higher levels in CRSwNP patients than in patients without polyps. Tezspire is an anti-TSLP monoclonal antibody that blocks TSLP activity at the upstream level of inflammatory pathways. Tezspire’s clinical efficacy and safety profile were confirmed in the global Phase III WAYPOINT trial.The WAYPOINT study was a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial conducted in 10 countries involving 408 patients aged 18 years and older with CRSwNP who had severe, uncontrolled symptoms.Results showed that at Week 52, the Tezspire treatment group demonstrated statistically significant improvements compared to the placebo group, with a decrease of -2.07 in the Nasal Polyps Score (NPS), which assesses the size and extent of nasal polyps, and a decrease of -1.03 in the Nasal Congestion Score (NCS), which assesses the degree of nasal congestion. Furthermore, these improvements were observed as early as week 4 and week 2 of treatment, respectively, and were sustained through week 52.Ji-young Kim, Executive Director of AstraZeneca Korea’s Respiratory Division, said, “We are pleased that we were able to expand Tezspire’s indication in Korea following FDA approval in October last year for CRSwNP. Clinical trials confirm Tezspire can be an effective treatment option not only for asthma but also for patients with CRSwNP, and we expect it to help patients manage their respiratory conditions.”Rhinosinusitis is characterized by two or more symptoms, including nasal congestion, nasal obstruction, or a runny nose, and becomes chronic when these symptoms persist for 12 weeks or longer. Additionally, when accompanied by nasal polyps, it is classified as CRSwNP.
- Company
- Boston Scientific Korea’s sales surpass ₩200 billion
- by Hwang, byoung woo Apr 10, 2026 08:26am
- Boston Scientific Korea has surpassed KRW 200 billion in sales following portfolio restructuring.Analysts attribute this revenue expansion to the robust growth of the Pulse Field Ablation (PFA) system, coupled with concurrent growth across all major therapeutic areas.According to a recent audit report, Boston Scientific Korea posted KRW 218.5 billion in sales in 2025, up 18.4% from KRW 184.6 billion the previous year.This marks the first time the company has surpassed KRW 200 billion in revenue since entering the Korean market, continuing its four-year growth streak from KRW 151.6 billion in 2022, KRW 175.3 billion in 2023, and KRW 184.6 billion in 2024.Operating profit also grew in tandem with topline growth, from KRW 9 billion in 2022, KRW 10.5 billion in 2023, KRW 11 billion in 2024, to KRW 13 billion in 2025.Increased PFA procedures for arrhythmia drive growthThe key driver behind the company’s growth lies in changes to the business portfolio. The product lines currently supplied by the company to domestic medical institutions span the cardiovascular, oncology, and urology fields. After previously attempting to enter the structural heart disease segment with TAVI before discontinuing the business, the company restructured its portfolio.Representative products include the AVIGO Plus coronary ultrasound imaging device, the TheraSphere liver tumor embolization device, and the Rezum system for benign prostatic hyperplasia.Among these various products, the PFA system had the greatest impact on growth last year.Unlike conventional radiofrequency ablation or cryoballoon ablation, PFA selectively destroys myocardial cells only, reducing procedure time by more than half and lowering complication risks, thereby expanding its influence in major domestic general hospitals.The Korean PFA market is currently contested by Boston Scientific, Medtronic, and Johnson & Johnson (J&J).Boston Scientific was the fastest to enter the Korean market, securing catheter certification for its FARAPULSE platform in April 2024 and generator approval in September.Analysts attribute this growth to the expanding market for electrophysiological procedures, driven by an increase in atrial fibrillation patients amid an aging population, with a recurring revenue model centered on related catheters and systems serving as the foundation for growth.In a Korea Health Industry Development Institute report on PFA, Professor Bo-young Joung of the Department of Cardiology at Severance Hospital stated, “PFA cuts procedure time by half compared with conventional methods and lowers complication risk, leading to high satisfaction among both physicians and patients. Currently, 35% of atrial fibrillation ablation procedures at Severance are performed using PFA, and this trend is expected to continue.”Given this, Boston Scientific Korea’s growth momentum is expected to strengthen further.Rezūm expansion and global M&A broaden business scopeAnother factor contributing to growth is the continued expansion of the Rezūm System, a medical device introduced in 2023 for benign prostatic hyperplasia, which has now surpassed 6,000 cumulative procedures in Korea.The Rezūm System received approval from the U.S. Food and Drug Administration (FDA) in 2015, obtained authorization from the Ministry of Food and Drug Safety in 2022, and was designated as a new health technology by the Ministry of Health and Welfare in 2023. Currently, Rezūm procedures are expanding their scope of application in clinical settings as a treatment option that can be considered even for patients unsuitable for medication or surgery.Regarding this, Boston Scientific Korea Country Manager Ae Ri Jung said, “Achieving 6,000 Rezūm procedures is a meaningful milestone demonstrating its establishment as a treatment option for BPH in Korea. We will continue contributing to expanding treatment options that improve patients’ quality of life.”As the portfolio expands, the company appears to be strengthening its field sales capabilities. Looking at the sales and administrative expenses, promotional expenses rose from KRW 6.3 billion in 2024 to KRW 7.1 billion in 2025.In particular, as Boston Scientific is pursuing mergers and acquisitions (M&A) on a global scale involving tens of trillions of won, its influence in the domestic medical market is expected to continue to grow in the future.The company acquired Axonics in 2024 to strengthen its urology portfolio, and in January, decided to acquire neurovascular treatment company Penumbra.In addition, it has also recently fully integrated Valencia Technologies, a urinary incontinence treatment company, rapidly expanding its portfolio.As the company expands its business scope to include new disease areas in addition to those that generate synergies with existing businesses, its business scale in the Korean market is also expected to grow.
- Company
- Will Verzenio’s reimbursement be extended to early breast cancer?
- by Eo, Yun-Ho Apr 10, 2026 08:25am
- Hope has been rekindled once again for expanded reimbursement of Verzenio in early breast cancer after three failed attempts.According to industry sources, the Breast Cancer Division of the Korean Society of Medical Oncology submitted an application to expand insurance reimbursement for Verzenio (abemaciclib), Eli Lilly Korea’s CDK4/6 inhibitor, in February. This marks the first time a medical society, rather than a pharmaceutical company, has taken the initiative to seek reimbursement coverage of a drug for early-stage breast cancer.Additionally, the society recently submitted a petition urging the Health Insurance Review and Assessment Service (HIRA) to expedite the review schedule for Verzenio’s listing, including the results of a signature campaign organized by the Union of Breast Cancer Patients.Accordingly, there is growing speculation that Verzenio could be brought before the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service in May, alongside Kisqali (ribociclib), another breast cancer treatment with the same mechanism that is currently undergoing the reimbursement process.Furthermore, Verzenio has secured data demonstrating an improvement in overall survival (OS), which was the biggest obstacle in the coverage expansion process last October.According to results from the monarchE study presented at the ESMO 2025 Annual Congress, at a median follow-up of 6.3 years, Verzenio combination therapy reduced the risk of death by 15.8% compared with endocrine therapy alone. The 7-year survival rates were 86.8% for Verzenio combination therapy and 85.0% for endocrine monotherapy, with an absolute difference of 1.8%.Verzenio faced difficulties in being reviewed by CDDC from its first attempt for early breast cancer. After a long wait of 6 months after submitting the reimbursement application, it was finally reviewed by CDDC in May 2023, but the result was “reimbursement criteria not set.” Five months later, in October, Lilly resubmitted the reimbursement application to HIRA, and in March and July last year, it was submitted to CDDC for review, to face the same results.Keun Seok Lee, Professor of the Center for Breast Cancer at the National Cancer Center, said, “The Verzenio+endocrine therapy combination is recommended with a high level of evidence in major national and international practice guidelines as adjuvant therapy for patients at high risk of recurrence. With various clinical studies and major academic society reviews confirming its clinical utility, we need to enable rapid access to the treatment through prompt reimbursement to improve the survival of patients at high risk of recurrence.”Meanwhile, a considerable number of drugs in the breast cancer field are still struggling to obtain expanded reimbursement. Perjeta (pertuzumab), which has become a standard of care in the postoperative adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence, has been approved in Korea for eight years but has yet to clear the hurdle for coverage.Unlike neoadjuvant chemotherapy (preoperative adjuvant therapy), which is covered under selective reimbursement at 30%, the postoperative adjuvant indication failed to obtain during the 2019 review because the drug lacked high-level recommendations in global guidelines and long-term follow-up data.However, the 10-year follow-up results from the global Phase III APHINITY study, released last year, are expected to fill this gap. According to the study, adjuvant therapy with Perjeta plus Herceptin (trastuzumab) demonstrated clear improvement, including a 21% reduction in the risk of death compared with trastuzumab alone in lymph node-positive patients at high risk of recurrence.
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- K-biosimilars gain influence in domestic market
- by Chon, Seung-Hyun Apr 08, 2026 07:46am
- Domestically developed biosimilars have gradually expanded their influence in the domestic market. Celltrion’s Remsima and Samsung Bioepis’s Onbevezi competed for the top spot by a narrow margin, both recording sales in the KRW 40 billion range. Celltrion’s Prolia biosimilar, joined by Daewoong Pharmaceutical, surpassed KRW 10 billion in sales in its first year of release. This trend reflects the increasing involvement of traditional pharmaceutical companies in biosimilar sales, which has strengthened market penetration.According to the Financial Supervisory Service on the 7th, Celltrion’s Remsima recorded KRW 45.5 billion in sales last year, up 3.4% year-on-year, securing the top spot among domestically developed biosimilars. In 2024, Samsung Bioepis’s Onbevzi took the lead with KRW 45.2 billion, but last year Remsima overtook it by KRW 5.5 billion. The figures are based on sales disclosed by Celltrion Pharm and Boryung, which handle domestic sales for Celltrion and Samsung Bioepis biosimilars, respectively.Remsima is a biosimilar of the autoimmune treatment Remicade. It was approved in 2012 as Korea’s first domestically developed antibody biosimilar. It is used to treat Crohn’s disease, ankylosing spondylitis, ulcerative colitis, and rheumatoid arthritis.Onbevzi is a biosimilar version of the oncology drug Avastin. It is an anticancer drug used to treat metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer.Being the first biosimilar product introduced to the domestic market, Remsima had long led sales, but the rapid growth of Onbevzi since its introduction shifted the market into a duopoly structure.In 2023, Remsima maintained a narrow lead of KRW 0.8 billion, but in 2024, Onbevzi overtook it for the first time by KRW 1.2 billion. However, Onbevzi’s sales declined 11.5% year-on-year to KRW 40 billion last year, allowing Remsima to regain the top position.The domestic biosimilar market is drawing attention as a battleground driven by traditional pharmaceutical companies’ sales capabilities.In the Avastin market, Samsung Bioepis launched Onbevzi in September 2021, followed by entries from Celltrion and Alvogen Korea. As the first entrant, Onbevzi maximized its advantage by leveraging tailored sales strategies. Samsung Bioepis also secured an exclusive domestic sales agreement with Boryung immediately after approval. Boryung is known for its strong presence in oncology sales.Celltrion’s biosimilars are marketed domestically through Celltrion Pharm. Celltrion’s Herzuma, a biosimilar version of Herceptin, recorded KRW 21.9 billion in sales last year, up 2.8%, ranking behind Onbevzi and Remsima. Truxima, a biosimilar version of MabThera, recorded KRW 12.3 billion in sales, up 7.9%.While domestically developed biosimilars are still far from achieving commercial success in the global market, they appear to be gradually expanding their influence with the support of traditional pharmaceutical companies.Last year, 8 of Celltrion’s 12 biosimilar product lines sold in the global market exceeded KRW 100 billion in sales. Remsima recorded sales of KRW 1.0495 trillion last year, surpassing the KRW 1 trillion mark for the second consecutive year.Remsima SC generated KRW 717.2 billion in sales, up 27.1% year-on-year. Zymfentra grew from KRW 36.6 billion in 2024 to KRW 122.2 billion last year, more than tripling and surpassing KRW 100 billion. Remsima SC is a subcutaneous formulation developed from the original intravenous Remsima, and it has been approved in the U.S. as a new drug under the name Zymfentra. Truxima and Herzuma generated sales of KRW 526.3 billion and KRW 217.1 billion, respectively, in the global market last year.Recently, sales competition has been intensifying with traditional pharmaceutical companies joining the biosimilar market en masse.Samsung Bioepis has established disease-specific sales capabilities tailored to biosimilars.It initially partnered with Daewoong Pharmaceutical for its Herceptin biosimilar in 2017 but switched to Boryung in 2021. Immediately after receiving domestic approval for Onbevzi, a biosimilar of Avastin, in 2021, the company signed an exclusive domestic sales agreement with Boryung. Samsung Bioepis selected Samil Pharmaceutical as the sales partner for biosimilars of Lucentis and Eylea, treatments for ophthalmic diseases.Last year, Samsung Bioepis selected Hanmi Pharmaceutical as its domestic sales partner for its Prolia biosimilar Obodence. Samsung Bioepis handles production and supply, while both companies jointly manage marketing and sales. Its original version, Prolia, which was developed by Amgen, works by inhibiting the activity of osteoclasts that break down bone, thereby preventing bone resorption and increasing bone density. It prevents bone loss in postmenopausal women and reduces the risk of fractures, while in cancer patients, it inhibits bone metastasis and protects bone structure to reduce complications.Daewoong Pharmaceutical signed a joint sales and distribution agreement with Celltrion Pharm last year and began domestic sales of Celltrion’s Prolia biosimilar, Stoboclo. Daewoong Pharmaceutical is conducting joint sales of Stoboclo with Celltrion Pharm at general hospitals and clinics nationwide. Celltrion has sold biosimilars in the domestic market through its affiliate, Celltrion Pharm. Stoboclo is the first Celltrion biosimilar to be sold by a pharmaceutical company other than Celltrion Pharm. Stoboclo generated sales of KRW 11.8 billion last year.Daewoong Pharm’s strategy is to expand prescriptions at major general and university hospitals nationwide to grow Stoboclo into a ‘mega blockbuster’ with annual sales exceeding KRW 100 billion. Currently, Stoboclo has been introduced to more than 50 major general and university hospitals nationwide, rapidly expanding its prescription base. Daewoong has also joined the sales efforts for LG Chem’s Humira biosimilar Xelenka.
- Company
- Tepmetko shifts MET-mutated lung cancer treatment paradigm
- by Son, Hyung Min Apr 08, 2026 07:46am
- The treatment landscape for non-small cell lung cancer (NSCLC) MET exon 14 skipping alterations is undergoing significant changes within one year of Tepmetko’s reimbursement introduction. In a rare mutation area where targeted treatment options were previously limited, both clinical efficacy and patient access have improved with the introduction of Tepmetko, prompting a redefinition of treatment strategies and highlighting the growing importance of biomarker-based precision medicine.On the 7th, Merck Korea held a press conference at the Fairmont Hotel in Yeouido, Seoul, to commemorate the first anniversary of the reimbursement of Tepmetko (tepotinib), a treatment for non-small cell lung cancer (NSCLC), and shared clinical outcomes and changes in the actual clinical setting.A view of the press conference marking the first anniversary of Tepmeco’s reimbursement coverage in KoreaTepmetko was approved in Korea in 2021 as a treatment for locally advanced or metastatic NSCLC with MET exon 14 skipping alterations and has been reimbursed since April last year. It works by selectively inhibiting MET phosphorylation and downstream signaling, thereby blocking tumor cell proliferation and migration.MET exon 14 skipping is a representative mutation that causes dysregulation of MET signaling and is known to promote tumor growth and metastasis. Although it is a rare mutation found in approximately 3–4% of metastatic NSCLC patients, it is associated with a poor prognosis and aggressive disease.Clinical evidence has also accumulated. In the global Phase II VISION study, Tepmetko demonstrated tumor reduction in over 90% of patients, with an objective response rate (ORR) of 58.6%, progression-free survival (PFS) of 15.9 months, and overall survival (OS) of 29.7 months. The duration of response was 46.4 months, confirming long-term treatment benefits.Subgroup analysis in Asian patients showed similar results, with an ORR of 56.6%, PFS of 13.8 months, and OS of 25.5 months, indicating consistent therapeutic benefits in patient populations including Koreans.Professor Ji-Youn Han of the Department of Hematology and Oncology at the National Cancer Center said, “Before Tepmetko’s introduction, there were no reimbursed treatment options targeting MET mutations, limiting patient access. Significant changes have emerged in the treatment landscape for rare lung cancers in the year since Tepmetko’s reimbursement.”Need grows for NGS-based testingProfessor Ji-Youn Han of the Department of Hematology and Oncology at the National Cancer Center\As targeted therapies for NSCLC continue to emerge, the need for next-generation sequencing (NGS) is also increasing.In NSCLC, multiple biomarkers exist, including MET, EGFR, ROS1, ALK, BRAF, KRAS, and RET. NGS offers the advantage of being able to test for these biomarkers all at once.While Professor Han positively noted that personalized treatment has become possible even for rare lung cancers such as those with MET mutations, she also pointed out the limitation of how access to NGS-based testing is limited for patients in practice.She explained, “In Korea, factors such as turnaround time (TAT), cost burden, and difficulty in obtaining adequate samples limit the broader adoption of NGS. While the current 50% patient co-insurance rate is acceptable, further efforts are needed to reduce cost burden and improve testing access to ensure accurate testing for more patients.” She added, “Tepmetko has demonstrated consistent response rates and durable treatment effects regardless of biopsy method (tissue or liquid biopsy) or line of therapy. NGS-based biomarker testing offers the advantage of proactively identifying patients who stand to benefit from treatment and providing concrete evidence for establishing treatment strategies and selecting medications.”
- Company
- Domestic approval of high-dose 'Spinraza' imminent
- by Son, Hyung Min Apr 08, 2026 07:46am
- SMA treatment 'Spinraza'Ahead of the introduction of 'Spinraza,' a high-dose regimen of the spinal muscular atrophy (SMA) treatment, to Korea following global approvals, the possibility of a shift in treatment strategy is being raised.The trend of improving effectiveness through dose optimization is evident, moving away from the existing low-dose (12mg) treatment.According to industry sources on the 8th, the domestic approval of Biogen Korea's Spinraza (nusinersen) high-dose formulations (50mg/5mL, 28mg/5mL) is imminent. An approval decision is expected within this month.Previously, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved the high-dose regimen. The strategy involves administering 50mg twice at 14-day intervals during the initial loading phase, followed by a 28mg maintenance therapy at 4-month intervals, thereby maximizing therapeutic effects by increasing the drug concentration compared to the existing regimen.Spinraza is an antisense oligonucleotide (ASO) that continuously increases SMN protein levels. To deliver treatment to the cause of the disease, it can be administered directly into the central nervous system, where motor neurons are located, via intrathecal injection. Since Spinraza allows multiple administrations, it can demonstrate differentiation in its administration method.Spinraza has confirmed a consistent effect and safety profile across all ages and types based on clinical research data and real-world evidence (RWE) accumulated over more than 8 years of treatment.The efficacy of the high-dose Spinraza was confirmed through the Phase 2/3 DEVOTE study. In the primary cohort analysis, the treatment-naïve symptomatic infant patient group showed a statistically significant improvement in motor function assessment (CHOP-INTEND).The treatment group recorded an average increase of +15.1 points, while the comparison group (untreated group) showed -11.1 points, resulting in a mean difference of 26.19 points. While motor function improved in the high-dose regimen group, it worsened in the untreated group, proving a distinct therapeutic effect compared to the natural course of the disease.Regarding safety, a profile similar to the existing low-dose regimen was confirmed. However, pneumonia, aspiration pneumonia, and malnutrition were reported as major adverse reactions in infant SMA patients.The high-dose drug can also be used in patients already receiving treatment. Patients who were maintaining low-dose treatment can continue maintenance therapy at the same 4-month intervals after a single high-dose loading, allowing for a dose increase while maintaining treatment continuity.This high-dose strategy is seen as a variable that can change the SMA treatment paradigm beyond simply adding an option. The approach to maximize treatment response is considered to have begun, given that dose optimization was pursued based on long-term (over 10 years) data from the existing treatment.In particular, as approvals have already been granted in major countries such as the U.S., Europe, and Japan, attention is focused on the timing of introduction and the reimbursement strategy in Korea. If the high-dose drug becomes a differentiated option compared to existing treatments, its impact on the overall SMA treatment landscape is expected to be significant.More treatment options…treatment choice based on mechanisms of action·administration methods·reimbursement The domestic SMA treatment includes Spinraza, Roche's 'Evrysdi (risdiplam)', and Novartis' 'Zolgensma (onasemnogene abeparvovec)'. All share the common goal of improving SMN protein deficiency but differ in their mechanisms of action and administration methods.Spinraza is an ASO-based treatment that acts on the central nervous system via direct intrathecal administration and has dominated the market based on long-term clinical data and prescribing experience. Evrysdi is an oral small-molecule treatment that regulates SMN2 splicing, characterized by its ability to cross the blood-brain barrier and act systemically.Zolgensma is a gene therapy that directly delivers the SMN1 gene, with therapeutic effects expected after a single administration.Recently, with the expansion of reimbursement criteria for Evrysdi, the flexibility of treatment strategies has greatly improved. The introduction of the tablet form, the extension of the prescription period (up to approximately 2 months), and the allowance of bidirectional switching with injections are evaluated as having made treatment choices based on patient conditions much more flexible.Ultimately, the SMA treatment trend is shifting away from a single, treatment-centered approach toward a customized strategy that considers the mechanism, administration method, and reimbursement criteria.
- Company
- Mounjaro reimb for diabetes remains uncertain in KOR
- by Eo, Yun-Ho Apr 08, 2026 07:46am
- Mounjaro, the star of the obesity treatment boom, has encountered a roadblock in its expansion of reimbursement for diabetes in Korea.According to industry sources, Eli Lilly Korea and the National Health Insurance Service (NHIS) failed to conclude pricing negotiations for Mounjaro (tirzepatide), a dual GIP/GLP-1 receptor agonist, within the deadline. A decision has now been made to extend the negotiation period.Whether Lilly and the NHIS will be able to reach an agreement and secure reimbursement listing for Mounjaro remains to be seen. Its competitor, Novo Nordisk’s Ozempic (semaglutide), which contains the same active ingredient as Wegovy, has been listed for reimbursement for diabetes since February.Mounjaro had previously passed the Drug Reimbursement Evaluation Committee (DREC) review under the Health Insurance Review and Assessment Service (HIRA) in December last year.Although it has generated exceptional sales as an obesity treatment, Mounjaro is also indicated in diabetes as an “adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (monotherapy or combination therapy) and for chronic weight management in adults with obesity (initial BMI ≥30 kg/m²) or overweight patients with at least one weight-related comorbidity (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease), in conjunction with a reduced-calorie diet and increased physical activity.”For both indications, the recommended starting dose is 2.5 mg once weekly (intended for treatment initiation, not for glycemic control or weight management). After four weeks, the dose is increased to 5 mg once weekly. If further dose adjustment is necessary, the dose may be increased by 2.5 mg increments after at least 4 weeks at the current dose, up to a maximum of 15 mg once weekly.Meanwhile, Mounjaro is drawing attention as the first treatment to suggest the possibility of “remission” in diabetes.In the Phase III SURPASS study, which became the basis for its approval, Mounjaro demonstrated its potential for diabetes remission by achieving statistically superior improvements in HbA1c and body weight compared to all control groups, including semaglutide (1 mg, brand name Ozempic), insulin degludec, and insulin glargine.Furthermore, at the European Association for the Study of Diabetes (EASD) meeting held last September, the company presented results from the Phase III SURPASS-CVOT clinical trial, which directly compared Mounjaro with Lilly’s GLP-1 receptor agonist Trulicity, thereby reinforcing data on cardiovascular prevention effects and improvements in overall survival.
