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- 2025-12-17 14:30:15
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- Gov't-Pharma meet for drug pricing system reform
- by Kim, Jin-Gu Nov 21, 2025 06:11am
- The Ministry of Health and Welfare (MOHW) and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KBPMA) Board of Directors have shared the direction for the upcoming reform of the drug pricing system. This initial meeting between the government and the pharmaceutical industry is expected to accelerate future discussions regarding the reform. According to the pharmaceutical industry on November 19, MOHW officials, including Lee Joong-kyu, Director-General of the Health Insurance Policy Bureau, attended the KBPMA Board of Directors meeting on the afternoon of November 18. It was the first meeting discussing the drug pricing system reform. During the meeting, the fundamental objectives and broad direction of the reform were shared. The government explained its policy to actively incentivize R&D investment by pharmaceutical and biotech companies and enhance access to new drugs. It was also mentioned that an adjustment to the generic drug price criteria must be made. Additionally, details on measures to stabilize the supply of essential medicines and to reorganize the post-market management system were shared. With the reform's general direction now shared with the industry, there is anticipation that discussions regarding the drug pricing system overhaul will gain momentum. The MOHW plans to finalize the draft reform plan based on the content shared at the meeting. The relevant agenda is expected to be reported to the Health Insurance Policy Review Committee scheduled for November 28. The discussions are expected to proceed after the Health Insurance Policy Review Committee report. While the report will outline the overall direction of the reform, subsequent discussions regarding detailed aspects, such as the generic drug pricing calculation rate, are expected to continue with the pharmaceutical industry's working-level consultative body. Considering the necessary procedures, a concrete outline of the drug pricing system reform is anticipated to emerge by the end of this year or early next year. The government is reportedly contemplating several changes, including adjusting the generic drug pricing calculation rate, reforming the tiered drug pricing system, merging post-market management systems, expanding the Risk-Sharing Agreement (RSA) and Dual Pricing systems, and implementing drug price bonuses linked to R&D investment ratios. First, there is a review to lower the generic drug calculation rate from the current 53.55% to below 50%. Under the current system, the price of a generic drug is set at 59.5% of the original drug's maximum price for the first year of listing, and this price is lowered to 53.55% thereafter. To receive the 53.55% rate, companies must meet both conditions: conduct their own 'bioequivalence test' and use a 'registered Active Pharmaceutical Ingredient (DMF)'. If only one condition is met, the price is reduced by an additional 15% (to 45.52% of the original price). If neither condition is met, it is reduced by another 15% (to 38.69% of the original). The government judges that the current 53.55% calculation rate is too high. Although the specific adjustment range has not been disclosed, industry forecasts suggest the rate could drop to around 40%. The tiered drug pricing structure is also an item for reform. Currently, the 53.55% rate applies to the first 20 generics listed, after which the price is reduced by 15% sequentially. Regarding this, there is discussion about narrowing the listing bracket from the current 20th generic to around the 10th, while simultaneously easing the drug price reduction rate to below 15%. The post-market management systems are expected to be merged and reorganized. This addresses criticism that various systems, such as the Actual Transaction Price-Based Drug Price Reduction, the Drug Reimbursement Appropriateness Re-evaluation, and the Price-Volume Agreement, operate in a complicated manner, reducing predictability. Discussions about integrated systems are expected to begin soon after the 'Research on a Integrated Mechanism for Post-market Drug Price Management' results are released. The drug price incentive system is likely to be reorganized to link preferential treatment to each pharmaceutical and biotech company's R&D investment ratio. An official from the pharmaceutical industry stated, "The government is clearly communicating that the market centered solely on generics has limitations for growth," and added, "I understand that discussions are proceeding toward simplifying the system and ensuring compensation for corporate innovation."
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- Topical JAK inhibitor 'Anzupgo cream' submitted for reimb
- by Eo, Yun-Ho Nov 20, 2025 06:16am
- Product photo of Topical JAK inhibitor 'Anzupgo cream' has been submitted for insurance reimbursement listing. According to industry sources, LEO Pharma Korea recently submitted a reimbursement application for Anzupgo (delgocitinib), a new drug for Chronic Hand Eczema (CHE). Attention is drawn to whether this first and only cream-formulation JAK inhibitor option will gain reimbursement option. Anzuupgo is the only non-steroidal topical cream formulation approved for the treatment of moderate-to-severe CHE in adult patients who have not responded to, or for whom topical corticosteroids are not advisable. Anzupgo does not contain parabens or steroids. It works by suppressing the JAK-STAT signaling pathway, which is involved in various inflammatory reactions, by inhibiting the activity of JAK1, JAK2, JAK3, and TYK2, thereby helping to alleviate skin inflammation and pruritus. Until now, treatment options for CHE have been limited, with strong topical corticosteroids primarily being used. However, prolonged use of these agents can carry various risks, including skin barrier damage, skin atrophy, and dilated blood vessels. For cases where treatment effects did not appear in a short period, Korean treatment guidelines also recommended combining them with topical calcineurin inhibitors or systemic steroids. GSK's 'Alitoc (alitretinoin)', currently the only approved oral treatment for severe CHE, is used in patients who have not responded to at least 4 weeks of potent topical corticosteroid therapy. It improves symptoms through its skin-regulatory, anti-inflammatory, and immunomodulatory actions. It is known to be effective for the long-term management of chronic, severe hand eczema with a high risk of relapse. However, its continued use has been limited by concerns over various side effects, including hepatotoxicity, hypothyroidism, dyslipidemia, and fetal malformation. Anzuupgo's efficacy was proven through the DELTA FORCE and DELTA 2 clinical studies, which included a direct comparison with GSK's Alitoc (alitretinoin). In the DELTA FORCE study, the primary objective was met, showing superiority over alitretinoin capsules when delgocitinib was evaluated at baseline and at Week 12 using the Hand Eczema Severity Index (HECSI) score. The DELTA 2 study enrolled 473 patients with moderate-to-severe CHE. Participants were randomized to either the delgocitinib cream or placebo cream application group, receiving treatment twice daily for 16 weeks. The primary endpoint was an Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) score of 0/1 measured at Week 16. Key secondary endpoints included the IGA-CHE score and the Hand Eczema Symptom Diary (HESD) score, both evaluated at Weeks 4 and 8. The results showed that the delgocitinib group significantly improved chronic hand eczema at Week 16 compared to the placebo group, meeting the primary and key secondary endpoints.
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- ‘4-drug regimen essential for treating heart failure’
- by Son, Hyung Min Nov 20, 2025 06:15am
- Heart failure remains one of the most dangerous cardiovascular diseases. Rather than simply causing fatigue or shortness of breath, it is a systemic disorder in which structural and functional impairment of the heart leads to reduced blood flow and multi-organ decline. In rapidly aging countries like Korea, prevalence is rising at an even faster pace. The prevalence of heart failure in Korea has increased by approximately 4.5-fold over the past 20 years, exceeding 26% among those aged 80 and older. More notably, the 5-year survival rate for heart failure is lower than that for major cancers like breast or prostate cancer. This demonstrates that it is no longer merely a chronic condition but a severe disease directly linked to survival. Amidst this shift towards heart failure becoming a severe disease, DailyPharm met with Professor Michael Böhm, Chair of the ESC Scientific Program Committee and Professor of Internal Medicine at Saarland University Hospital, and Professor Byung-Su Yoo, President of of the Korean Heart Failure Society and Professor of Cardiology at Yonsei University Wonju College Hospital to discuss the the current state of heart failure and the challenges in the Korean treatment environment. (from the left) Prof Michael Boehm, Prof Byung-Su YooBoth experts highlighted the particularly rapid disease progression and high readmission risk associated with heart failure with reduced ejection fraction (HFrEF), emphasizing that “early treatment determines survival.” Among heart failure types, HFrEF is known for its rapid worsening, with more than 20% of patients readmitted within one year after discharge. Rehospitalization not only signifies worsening prognosis but also directly leads to increased mortality. Consequently, global guidelines explicitly state that ‘the success of HFrEF treatment hinges on the initial treatment strategy.’ This means that the only evidence-based strategy to improve survival rates is to promptly initiate the four pillars of heart failure therapy (ACE inhibitors or angiotensin receptor neprilysin inhibitors, beta-blockers, mineralocorticoid antagonists, and SGLT-2 inhibitors) upon diagnosis and uptitrated to target doses as quickly as possible. Among these, Entresto (sacubitril/valsartan), a representative ARNI therapy, is the most crucial pillar in HFrEF treatment. In the landmark PARADIGM-HF study, Entresto reduced cardiovascular death and heart failure hospitalization by 20% compared to the conventional ACE inhibitor enalapril, completely shifting the HFrEF treatment paradigm. Consistent results showing reduced risks of sudden death and emergency room visits provided the rationale for transitioning from the RAAS monotherapy era to a new standard of care centered on ARNIs. Germany is a prime example of a country where this shift was swiftly implemented in clinical practice. Standard therapy, including Entresto, is applied early on to most HFrEF patients, and a standardized heart failure care pathway, prioritizing achieving target doses, is already firmly established in the country. By contrast, Korea continues to face criticism for a low four-drug application rate and inadequate dose titration. Experts emphasize that such gaps ultimately translate into survival disparities, stressing the need for early treatment optimization. Q. What is the proportion of HFrEF patients, and what are the key clinical characteristics of the disease? eb Prof Byung-Su YooProf. Yoo: While data varies, the Korean Heart Failure III Registry, which focuses on tertiary hospital patients, shows approximately 55% or more cases are HFrEF. This reflects the patient population characteristics of tertiary hospitals, which treat a high proportion of severe cases. In actual clinical practice, with preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF) would be more common. This distribution is becoming more pronounced due to the recent increase in elderly and obese patients. HFrEF is characterized by significantly impaired systolic function, faster progression, and more severe symptoms such as dyspnea, edema, and fatigue. Prof. Michael: In Europe, HFrEF is also estimated at around 50%, but the actual proportion may be higher. Women with hypertension, atrial fibrillation, stroke, or diabetes were often classified as HFpEF in the past. Under the latest criteria, they may now be reclassified as HFrEF or HFmrEF. This shift suggests that heart failure classification based on ejection fraction may be revised in the future. Q. What is the evidence supporting the establishment of the four-drug regimen as the standard treatment for heart failure? Prof. Yoo: The standard treatment for heart failure is a therapeutic strategy established based on decades of accumulated clinical research. The effects of existing medications—beta-blockers, ACE inhibitors, ARBs, and MRAs—in reducing mortality and rehospitalization have been consistently demonstrated through large trials. The addition of SGLT2 inhibitors completed the four foundational pillars, and RAAS inhibitors are now shifting toward ARNI class drugs. Crucially, evidence shows that applying all four drugs together can reduce the risk of death or hospitalization by over 70%. Therefore, unless there are specific contraindications, actively using this regimen from the outset is key to improving prognosis. It is established as standard therapy that must be adhered to unless there are specific reasons not to, due to its clear efficacy in improving major events (hard outcomes). The standard therapy mentioned has already been proven effective in numerous studies. Specifically, using these four standard drugs can reduce mortality and hospitalization rates by approximately 70% or more, with this benefit observed in one out of every four patients. Prof. Michael: Heart failure pharmacotherapy has long evolved toward regulating the neuroendocrine axis. ACE inhibitors and MRAs were developed first, and major large-scale clinical trials established the current treatment foundation. As these studies accumulated, mortality rates in heart failure patients gradually decreased. Indeed, meta-analyses show that mortality and hospitalization rates decrease by approximately 65% when initiating all four agents together. Q. Why is Entresto preferred over other RAAS inhibitors? Prof. Yoo:The rationale for prioritizing Entresto (ARNI) is clearly demonstrated in the PARADIGM-HF study. In this study, Entresto reduced major hard outcomes, including death and hospitalization, by approximately 20% compared to the existing ACE inhibitor enalapril. This study is particularly significant because it demonstrated superiority not against a placebo, but directly against the then-standard of care, an ACE inhibitor. Mechanistically, the ARB (valsartan) is combined with a novel mechanism—a neprilysin inhibitor (sacubitril)—which synergistically enhances sodium excretion, vasodilation, and myocardial protection. These biological effects translated into actual clinical outcomes, establishing ARNI as the new standard that replaces existing RAAS inhibitors. Prof Michael Boehm#Prof. Michael: PARADIGM-HF can be regarded as a study that changed the treatment paradigm for heart failure. It presented a new mechanism capable of replacing ACE inhibitors, the existing standard therapy, and as a large-scale randomized study, it secured long-term data, demonstrating high stability and reliability. Recruiting a control group of this scale again would be practically difficult, making it unlikely that a comparable study could be replicated. Entresto demonstrated significant improvements not only in the primary endpoint but also in patients' quality of life (QoL). Survey-based assessments showed substantial relief in patients' overall well-being and symptom burden, carrying profound clinical significance for heart failure patients, particularly those with HFrEF. Furthermore, it demonstrated superior renal function preservation compared to ACE inhibitors and even confirmed the long-term benefit of reducing the risk of developing diabetes. These additional benefits can be seen as a result of the complementary properties of the sacubitril and valsartan combination, holding great significance in that it can provide patients with a better clinical experience across the entire spectrum of heart failure treatment. Why must all four therapies as standard therapy be initiated “as early as possible”? Prof. Yoo: HFrEF is a disease with a particularly poor prognosis at diagnosis, with many patients experiencing a rapid deterioration within the first 3 months. Since this is the period with the highest risk of death and rehospitalization, the four-drug standard therapy regimen must be introduced as quickly as possible. The effect of these medications is not merely symptom relief; they rapidly reduce mortality and hospitalization rates. Delaying treatment means immediately forfeiting these benefits. Numerous studies have accumulated showing that the earlier these medications are applied in HFrEF patients, the greater the improvement in prognosis. Consequently, both domestic and international guidelines emphasize early intervention. Prof. Michael: The reason early intensive therapy is crucial is that there exists a clinical golden time for heart failure. From the moment of initial diagnosis, myocardial stress in HFrEF patients increases rapidly, and structural and functional damage progress quickly during this process. Therefore, the four drugs must be initiated as soon as possible before the benefits of treatment accumulate. Furthermore, a sequential, delayed introduction of medications can result in leaving the patient's clinical risk unaddressed. Large-scale patient data also consistently show that rapid initiation of combination therapy improves survival rates and reduces hospitalization risk compared to monotherapy or delayed initiation. For these reasons, Europe also operates treatment strategies aiming for early completion of the four-drug regimen whenever possible. Q. South Korea still has a low initial adoption rate for the four-drug regimen. What tasks are necessary for improvement? Professor Yoo: The reasons for suboptimal initial treatment optimization in Korea involve a complex interplay of factors: time and environmental constraints on healthcare providers, patient concerns about polypharmacy, and staffing burdens in clinical settings. However, given the substantial clinical benefits of the four-drug regimen, establishing it as the common clinical pathway is necessary. Strengthening the role of heart failure centers and specialized clinics, establishing integrated treatment algorithms applicable from the initial visit stage, and creating structures that facilitate active dose titration in clinical practice are crucial. This should be accompanied by patient education to improve medication adherence and policy support to ensure consistent treatment standards across regional healthcare institutions. In terms of clinical inertia, a particularly unique situation in Korea is that healthcare providers have very limited time when seeing outpatients and must manage a large volume of patients. This makes it extremely difficult to carry out standard treatment or personalized therapy for patients. To summarize, the target level for standard treatment in Korea has significantly improved. However, it can be said that there is still room for improvement for many practitioners, excluding specialists who specifically treat heart failure patients. Prof. Michael: As seen in Germany, a ‘standardized clinical pathway’ is key to increasing early treatment initiation rates. We need a system that allows any doctor to design treatment based on the same criteria, rather than relying on the experience and skill level of individual clinicians. Furthermore, in the process of managing patients to reach the maximum tolerated dose of medication, it is crucial to establish time flexibility and a continuous monitoring system in the clinical setting. Indeed, the standard four-drug regimen that includes Entresto achieves optimal efficacy only when doses are sufficiently titrated. Therefore, expanding outpatient, nursing, and educational systems for this purpose is absolutely essential. A national-level management model would ultimately narrow Korea’s treatment gap and improve outcomes for many patients.
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- RED Period Campaign successfully concludes to end HIV stigma
- by Son, Hyung Min Nov 20, 2025 06:14am
- Participants in the RED Preiod Campaign The RED Period Council (RED Council), a joint initiative among academia, patient advocacy groups, and industry aimed at ending stigma and discrimination against HIV, announced that it successfully held the “Red Period Campaign – Citizen Participation Event” at Cheonggye Plaza in Seoul on the 17th. Since the first reported cases over 40 years ago, HIV (Human Immunodeficiency Virus) treatment has progressed dramatically. Today, with consistent medication adherence and regular care, HIV can be managed like other chronic conditions, such as diabetes or hypertension. However, despite these scientific advances in treatment and prevention, people living with HIV and key populations still face significant barriers due to persistent misconceptions, social stigma, and discrimination. To mark World AIDS Day (December 1), the council hosted this public event to deliver accurate information and break down prejudices surrounding the disease. During the event, representatives of the council, including Prof. Beom-Sik Chin (Infectious Diseases, National Medical Center), Seok-Soo Son (President, KNP+), Seung-Hwan Kim (Executive Director, Sinanun Center), Jong-Hyuk Lee (Director, Public Communication Research Institute), and Jae Yeon Choi (General Manager, Gilead Sciences Korea), took the stage to reaffirm their commitment to eliminating HIV-related stigma and discrimination. Participants also read aloud messages of encouragement submitted through the Naver Happy Bean Good Action campaign page, which has been active since October, and urged continued public participation in the RED Period Campaign The event featured several programs, including ▲a calligraphy performance by artist So-Young Kim interpreting the campaign’s core messages, ▲a video highlighting the campaign’s meaning from the perspectives of people living with HIV, supportive video messages from actors, and ▲a celebratory performance by singer Seung Yeon Son delivering messages of hope and comfort. TV personality Seok-Cheon Hong, long recognized for his advocacy on LGBTQ+ and HIV-related human rights issues, hosted the event. Ambassador Philippe Lafortune of the Embassy of Canada to the Republic of Korea, Seung-kwan Im (Commissioner, Korea Disease Control and Prevention Agency), Sun-Hee Lee (President, The Korean Society for AIDS), and Jae Yeon Choi (GM, Gilead Korea) also offered welcome remarks in support of the campaign. Many citizens are participating in various participatory programs held at Cheonggye Plaza to end HIV discrimination and prejudice. Additionally, the ‘HIV Stigma and Bias Elimination Experience Zone’ set up throughout Cheonggye Plaza offered various programs to help citizens improve their accurate understanding and awareness of the disease. Citizens learned accurate disease information by physically breaking apart and reassembling a large puzzle featuring discriminatory and prejudiced statements about HIV. Additionally, they participated in activities like taking photos, pledging support for the RED Period Campaign, writing messages of encouragement, and joining together to place full stops, contributing to the movement for improved HIV awareness and solidarity. Prof. Beom-Sik Chin of the Department of Infectious Diseases at National Medical Center said, HIV is no longer a fatal acute infection but a manageable chronic disease. As treatment has advanced, eliminating stigma-driven declines in quality of life among people living with HIV must be addressed urgently. The medical community will continue to play an active role in ending HIV-related discrimination and prejudice.” Jae Yeon Choi, General Manager of Gilead Sciences Korea, said, “Gilead is leading scientific innovation and improving access to care in the treatment of HIV, one of the world's most deadly diseases. The RED Period Campaign will be a crucial turning point in reducing new infections and ultimately ending HIV transmission. Gilead Korea will spare no effort in supporting this journey.” Includes the Korean Society for AIDS, Hamkke-Seo-Bom Foundation, KNP+, Love for One, Shinnaneun Center, Public Communication Research Institute, and Gilead Sciences Korea. Since its launch in September, the council has focused on improving awareness, strengthening treatment and prevention environments, and driving institutional and policy advancement with the long-term goal of reducing new HIV infections by 50%.
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- Remsima-Onbevzi compete for No.1 rank in the biosimilar mkt
- by Chon, Seung-Hyun Nov 19, 2025 06:10am
- Celltrion's Remsima and Samsung Bioepis' Onbevzi are fiercely competing for the top spot in the Korean biosimilar market. Remsima has now surpassed Onbevzi's sales after nine quarters, following its previous lead in Q4 of last year. Both Remsima and Onbevzi generate quarterly revenues exceeding KRW 10 billion, proving the commercial viability of domestically developed biosimilars. The entry of traditional pharmaceutical companies into the sales of these biosimilars is attributed to the stable market growth. According to the Financial Supervisory Service on November 17, Celltrion's Remsima recorded sales of KRW 12.5 billion in the third quarter, up 11.5% year on year. Remsima surpassed Onbevzi's sales of KRW 10.5 billion by KRW 2 billion, marking the highest domestic revenue among domestically developed biosimilars. This record is based on sales figures disclosed by Celltrion Pharm and Boryung, the companies selling biosimilars from Celltrion and Samsung Bioepis, respectively. Quarterly sales of major domestically-developed biosimilars. ORANGE-Remsima, BLUE-Onbevzi, GREEN-Herzuma (unit: KRW 1 million, source: Financial Supervisory Service) Remsima is a biosimilar of Remicade, the treatment for autoimmune diseases. It was approved in 2012 as the first domestically developed antibody biosimilar and is used to treat Crohn's disease, ankylosing spondylitis, ulcerative colitis, and rheumatoid arthritis. Onbevzi is a biosimilar of the anti-cancer drug Avastin. It is used for 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. This is the first time in three quarters, since Q4 of last year, that Remsima has surpassed Onbevzi's sales. Remsima led Onbevzi by KRW 1.6 billion in Q4 of last year, with KRW 12.1 billion in sales. However, Onbevzi took the lead in Q1 of this year with KRW 10.9 billion, surpassing Remsima by KRW 1.7 billion. Q2 sales of Onbevzi exceeded those of Remsima by KRW 700 million. Remsima had maintained the sales lead among domestically developed biosimilars for 10 years after its launch. Onbevz first surpassed Remsima in Q1 2023 with KRW 9.2 billion in sales, leading by KRW 1 billion. Remsima retook the lead in Q2 2023 with KRW 13.4 billion, surpassing Onbevz by KRW 3.3 billion, but then conceded the lead to Onbevz from Q3 2023 to Q3 of last year, with sales between KRW 8 billion and KRW 9 billion. Since then, Remsima and Onbevz have repeatedly traded the lead. Sales have reversed a total of five times between Remsima and Onbevz over the past three years since 2023. Onbevzi became a stable cash cow, recording sales of over KRW 10 billion for 10 consecutive quarters since first crossing the KRW 10 billion mark in Q2 2023. However, Onbevzi's growth has slowed slightly since recording KRW 11.7 billion in sales in Q2 of last year. After declining to KRW 11.5 billion in Q3 and KRW 10.6 billion in Q4 of last year, it rebounded to KRW 10.9 billion in Q1 of this year, but its sales in Q2 and Q3 slightly decreased from the previous quarter. In the Avastin market, Samsung Bioepis launched Onbevzi in September 2021, followed by Celltrion and Alvogen Korea. Onbevzi, the first biosimilar to enter the market, was equipped with a customized sales force, thereby maximizing its synergy. Samsung Bioepis signed an exclusive domestic sales agreement with Boryung immediately after Onbevzi's approval in South Korea. Boryung is a domestic company with strengths in oncology. Onbevzi's cumulative sales for the first three quarters were KRW 31.7 billion, a 8.4% year-on-year decrease, but it still led Remsima's sales of KRW 31.3 billion by KRW 400 million. Remsima's cumulative sales for the first three quarters decreased by 1.5% from the previous year. Celltrion's Herzuma, a biosimilar of the anti-cancer drug Herceptin, followed Onbevz and Remsima, recording KRW 4.3 billion in Q3 sales, a 21.0% decrease year-on-year. Herzuma's cumulative sales for the first three quarters totaled KRW 15.7 billion, a 1.6% year-on-year decrease. Recently, traditional pharmaceutical companies have entered the biosimilar market. Domestic biotech companies have successfully commercialized 26 biosimilar products across 15 markets. Domestic companies began actively entering the biosimilar market when Celltrion received approval for Remsima in 2012. Celltrion has received MFDS approval for biosimilars targeting Herceptin, MabThera, Humira, Avastin, Eylea, Stelara, Xolair, Prolia, Xgeva, and Actemra. Samsung Bioepis received approval for Etoloce, its first biosimilar product, in 2015. The original drug for Etoloce is Enbrel. Samsung Bioepis has successfully commercialized biosimilars targeting Remicade, Humira, Herceptin, Avastin, Lucentis, Soliris, Eylea, Stelara, Prolia, and Xgeva. LG Chem received approval for Eucept, an Enbrel biosimilar, in 2018 and a Humira biosimilar in 2023. Chong Kun Dang launched biosimilars in the Nesp and Lucentis markets. Samsung Bioepis initially launched the Enbrel biosimilar Etoloce in 2015 and the Remicade biosimilar Remaloce in 2016 through MSD Korea, but transferred the domestic rights for both products to Yuhan in 2017. Yuhan also secured the rights for Samsung Bioepis' Humira biosimilar, Adaloce, in 2021. However, since March of last year, Samsung Bioepis newly established its own sales organization and began direct sales of three autoimmune disease treatments. Samsung Bioepis selected Daewoong Pharmaceutical as its sales partner for Samfenet in 2017, but replaced the partnering company with Boryung in 2021. In 2021, it signed an exclusive domestic sales agreement with Boryung immediately after the domestic approval of the Avastin biosimilar, Onbevzi. Samsung Bioepis chose Samil Pharm as its sales partner for the ophthalmology treatments Lucentis and Eylea biosimilars. Samsung Bioepis selected Hanmi Pharmaceutical as its sales partner for the Prolia biosimilar, Obodence. Prolia, developed by Amgen, works by inhibiting bone resorption and increasing bone density by suppressing osteoclast activity (cells that break down bone). It prevents bone loss and reduces fracture risk in postmenopausal women, suppresses bone metastasis, and protects bone structure, reducing complications in cancer patients. Samsung Bioepis, as the developer of the Prolia biosimilar, is responsible for product production and supply, while both companies jointly handle marketing and sales activities. Daewoong Pharmaceutical entered a co-promotion and distribution agreement with Celltrion Pharm and began domestic sales of Celltrion's Prolia biosimilar, Stoboclo. Daewoong Pharmaceutical jointly sells Stoboclo with Celltrion Pharm in general hospitals and clinics nationwide. Celltrion previously sold its biosimilars in the domestic market through its affiliate, Celltrion Pharm. Stoboclo is the first Celltrion biosimilar sold by a pharmaceutical company other than Celltrion Pharm. Daewoong Pharmaceutical also joined LG Chem's sales effort for its Humira biosimilar, Xelenka.
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- Leqvio may reshape the mkt for statin-intolerant patients
- by Eo, Yun-Ho Nov 19, 2025 06:09am
- Leqvio, the dyslipidemia treatment administered once every six months, is rapidly expanding its presence by targeting niche patient segments. The treatment is gaining traction, particularly among patients with statin intolerance, those with a family history of dyslipidemia, and those who prefer a biannual, physician-administered injection schedule. Novartis Korea’s Leqvio (inclisiran) is the first-in-class siRNA therapy approved in Korea. It received domestic approval in June 2024 as an adjunct to diet for patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidemia. Leveraging naturally occurring siRNA mechanisms, Leqvio inhibits the production of PCSK9, a protein that increases LDL cholesterol, thereby reducing circulating LDL-C levels. A key advantage is its twice-yearly administration by healthcare professionals, which removes the burden and fear associated with self-injection. Experts note that Leqvio’s introduction brings more than just improved convenience. Professor Young Bin Song of the Department of Cardiology at Samsung Medical Center said, "Leqvio effectively lowers LDL-C with just two injections per year, fundamentally changing the strategy of lipid-lowering therapy (LLT). Maintaining lowered LDL-C levels over the long term plays a crucial role in reducing cardiovascular disease risk. Therefore, the 6-month dosing interval offers value that goes beyond convenience.” Leqvio specifically targets patients with statin intolerance, addressing the unmet need in the existing dyslipidemia treatment market dominated by statins. Currently, 39% of Korean patients with high cholesterol levels do not use lipid-lowering drugs, which inevitably increases their risk of cardiovascular disease. Professor Song said, “High-intensity statins, the first-line LLT, require daily administration. Unfortunately, patient adherence rates are not high. Discontinuation often occurs due to adverse reactions like liver or kidney function impairment, muscle pain, or daily inconvenience from muscle pain, creating challenges in lipid management.” Meanwhile, the results of the V-DIFFERENCE study, a Phase 4 clinical trial evaluating the LDL-C target achievement rate in patients with hypercholesterolemia who received either LLT optimized for individual patients plus Leqvio or LLT plus placebo, were recently presented at the European Society of Cardiology Congress (ESC 2025). This study holds significance as the first to evaluate Leqvio’s effect on muscle symptoms and pain commonly observed in patients receiving statins and other LLT treatments. Secondary endpoints included the proportion of patients experiencing at least one muscle-related adverse event (MRAE) after 360 days of treatment and the proportion reporting self-reported pain. Results showed that the Leqvio treatment group achieved significantly higher rates of individual LDL-C target attainment compared to the placebo group. Furthermore, the likelihood of muscle-related adverse events (MRAEs) was 43% lower in the Leqvio group than in the placebo group, and numeric improvements were also observed in pain-related quality of life (QoL) scores. Professor Song stated, “Given that some patients undergoing statin therapy suffer from side effects like muscle pain, this study reaffirms that Leqvio can serve as a viable treatment option that can address the unmet needs of existing LLT strategies.”
- Company
- GC Biopharma's U.S. plasma centers are fully operational
- by Chon, Seung-Hyun Nov 19, 2025 06:08am
- ABO Plasma, GC Biopharma's recently acquired U.S. plasma center, is seeing rapid revenue growth, with third-quarter sales exceeding those of the first and second quarters combined. The plasma centers, acquired for KRW 138 billion, has started full operations as its locations received U.S. approvals, leading to expanded sales of GC's blood products in the U.S. market. According to the Financial Supervisory Service on November 19, ABO Plasma recorded sales of KRW 43.1 billion in the third quarter. This represents a fourfold increase from the previous quarter's KRW 9.1 billion. The cumulative revenue for the first three quarters totaled KRW 65.4 billion. ABO Plasma is a U.S.-based plasma center that GC Biopharma acquired in January of this year. Immediately following the acquisition, ABO Holdings was renamed ABO Plasma. GC Biopharma decided to acquire a 100% stake in ABO Plasma for KRW 138 billion in December of last year. ABO Plasma, located in California, operates plasma centers in New Jersey, Utah, and California. The purpose of the acquisition was to expand the business for the blood product Alyglo and secure a stable source of raw materials. Alyglo, which received U.S. Food and Drug Administration (FDA) approval in December 2023, is a liquid immunoglobulin preparation refined from plasma fractionation. It is used to treat primary immunodeficiency diseases, such as congenital immunodeficiency and immune thrombocytopenia. Alyglo was the first blood product developed by a Korean company to enter the U.S. market. GC Biopharma established a system in which it uses plasma supplied by ABO Plasma to manufacture Alyglo at its Ochang plant in Korea, and sells the finished product in the U.S. Previously, GC Biopharma purchased plasma from U.S. plasma centers before manufacturing Alyglo at its Ochang plant. ABO Plasma generated revenues of KRW 13.2 billion and KRW 9.1 billion in the first and second quarters, respectively, and then skyrocketed in the third quarter. The third-quarter revenue alone was about double the revenue of the first half. At the time of GC Biopharma's acquisition of ABO Plasma, three of the total six plasma centers had already received FDA approval. An additional three centers received FDA approval in the second quarter. U.S. plasma centers can collect plasma from donors after opening, but they can only sell the plasma once they receive FDA approval. Since ABO Plasma's centers received FDA approval in succession following the acquisition, plasma sales revenue has gradually expanded. U.S. sales of Alyglo are also gradually increasing. The company explained, "Alyglo has maintained growth every quarter this year, achieving 117% sales growth compared to the same period last year." GC Biopharma proactively secured local inventory by increasing Alyglo export volume in the first half of the year to respond preemptively to changes in U.S. tariff policy. GC Biopharma recorded KRW 133.6 billion in blood product sales in the third quarter. This is similar to the KRW 136.6 billion recorded in the same period last year, but represents a 33.7% increase compared to KRW 99.9 billion in Q3 2023. GC Biopharma began full-scale sales after completing the initial shipment of Alyglo in July of last year. Blood product sales recorded KRW 90.6 billion in Q2 last year, expanded by 50.8% to KRW 136.6 billion in Q3 with Alyglo's launch, and rose to KRW 161.7 billion in Q4. This year, Q1 and Q2 recorded KRW 127.2 billion and KRW 152.0 billion, respectively. ABO Plasma is accelerating its facility expansion. On November 16, ABO Plasma opened the Laredo Plasma Center in Texas. ABO Plasma plans to start recruiting plasma donors immediately upon the center's launch. Collected plasma can be stored for 24 months, and the company plans to begin sales as soon as FDA authorization is complete. The FDA approval process for a plasma center typically takes nine months, and ABO Plasma expects to complete approval by the first half of next year. The Laredo Plasma Center was initially scheduled for completion in 2026, but expansion was accelerated to keep pace with Alyglo's growth and the domestic plasma fractionation products. The Eagle Pass Plasma Center in Texas is also expected to open in 2026. ABO Plasma recorded a net loss of KRW 5.7 billion in the third quarter. The company's deficit slightly increased, following net losses of KRW 5.1 billion and KRW 5.5 billion in the first and second quarters, respectively. The increased deficit compared to the previous quarter is attributed to higher costs associated with the early opening of the Laredo Plasma Center in Texas and to the recognition of one-time investment costs to build a foundation for mid- to long-term growth. The cumulative net loss for the first three quarters is KRW 16.2 billion. GC Biopharma utilized its internally established investment vehicle to acquire ABO Plasma. The acquisition involved investing GC Biopharma's existing cash reserves of KRW 55.7 billion and disposing of its stake in of the private equity firm 'For Human Life Private Equity Joint Venture No. 1' for KRW 82.3 billion. GC Biopharma Holdings and GC Biopharma jointly established For Human Life in March 2021, each investing KRW 6.4 billion. For Human Life subsequently launched 'For Human Life Private Equity Joint Venture No. 1' after receiving an investment of KRW 67.0 billion from GC Biopharma.
- Company
- Will the 53.55% generic drug pricing system be overhauled?
- by Kim, Jin-Gu Nov 18, 2025 06:12am
- The Korean government is moving toward a full-scale overhaul of the national drug pricing system Structural overhauls of the overall domestic drug pricing system are materializing, including adjustments to the generic drug pricing calculation rate, reform of the tiered pricing system, consolidation of post-marketing control systems, expansion of risk-sharing agreement and dual pricing systems, and introduction of R&D investment-linked drug pricing premiums. According to industry sources on the 18th, the Ministry of Health and Welfare is scheduled to attend the Korea Pharmaceutical and Bio-Pharma Manufacturers Association’s board meeting this afternoon to explain the direction of the drug pricing system reform. It is understood that Lee Jung-kyu, Director-General of the Bureau of Health Insurance Policy, will personally explain the reform's purpose and direction and request the pharmaceutical industry's participation. The Ministry has been continuously discussing the reform of the drug pricing system. Discussions have accelerated, particularly since the inauguration of the Lee Jae-myung administration. The outline has been shaped to simplify an overly complex system, making it more predictable, while simultaneously encouraging R&D investment by domestic pharmaceutical and biotech companies. A draft of the reform plan is reportedly already prepared. Following the ministry's briefing to the KPBMA, the discussions on drug pricing system reform, which have been progressing behind the scenes, are expected to move into the official phase. The focal point of interest is the generic drug price calculation rate. Lowering the current 53.55% rate is understood to be one of the core elements of the reform plan. Under the current system, the generic drug price is set at 59.5% of the original drug's highest price for the first year after initial listing. From the second year onward, the price is maintained at a reduced rate of 53.55%. To qualify for the 53.55% rate, both conditions must be met - ‘conducting its own bioequivalence test’ and ‘using a registered Drug Master File registered API.’ Meeting only one condition results in an additional 15% reduction (45.52% of the original price). Failing to meet both conditions leads to a further 15% reduction (38.69% of the original price). The government believes the current 53.55% benchmark is excessively high. Although the exact adjustment level has not been disclosed, industry insiders expect a considerably lower figure, potentially around 40%. An industry official stated, “If the discussion were merely about lowering the 53.55% calculation rate to 50%, the reform talks wouldn't have even started. The consensus is that the final figure will be below 50%.” The tiered generic pricing system is also expected to face revisions. Currently, the first 20 generic products maintain the 53.55% price level, and after the 20th, the price is reduced by 15% sequentially. The 21st generic is priced at 85% of the lowest price among the first 20 products, and the 22nd generic is priced at 85% of the 21st generic, and so on. In this regard, the Ministry of Health and Welfare considers the ‘20-product’ range as excessively broad. It is reported that a plan to reduce this to around 10 products is under review. However, it is understood that discussions are also underway to moderate the structure where prices drop by 15% after the 20th product, meaning fewer generics per tier, but smaller price drops per step. A major consolidation of post-management regulations is also underway. Current systems, including the ▲ Actual Transaction Price (ATP) reduction, ▲ reassessment of reimbursement adequacy, and ▲ the Price-Volume Agreement system, run simultaneously. The government has also previously considered introducing an external reference pricing-based reevaluation. The Ministry of Health and Welfare plans to consolidate these systems to enhance predictability. To this end, the Ministry commissioned a study titled “Integrated Framework for Post-Management of Drug Pricing” to the Daegu Catholic University Industry-Academic Cooperation Foundation in March this year. Once the results are released at the end of the year, related discussions are expected to accelerate. The drug price premium system is also likely to undergo a significant overhaul. Given persistent criticism that the current premium system is overly complex, the government is considering a method to determine drug price premiums and preferential treatment based on the R&D investment ratio of pharmaceutical and biotech companies. A pharmaceutical industry insider stated, “It is clear that the government intends to overhaul the multi-product, generic-centered market structure. Based on the judgment that the system has become excessively complex due to additions made as needed over time, discussions are proceeding toward streamlining it within a broad framework to enhance predictability. The government intends to strongly convey the message that growth is no longer feasible solely through a generic-centered market.” A government-ruling party official explained, “The focus of this reform is not on cutting healthcare spending. The goal is to create an environment where pharmaceutical innovation can function properly. We are reviewing options such as linking pricing premiums to the company’s R&D investment ratio. The intent is to make R&D investment a key determinant of reward.”
- Company
- 'True innovation requires guaranteed access to new drugs'
- by Son, Hyung Min Nov 18, 2025 06:09am
- A recent survey on perceptions of pharmaceutical innovation showed that the vast majority of Koreans believe innovation should be assessed not only by clinical efficacy but also by whether patients can realistically access and use the treatment. The survey, commissioned by global pharmaceutical company BeOne Medicines and conducted by research firm Embrain from August to October 2025, aimed to objectively understand public perceptions of new drug accessibility and the need for improvement. A total of 1,000 Korean adults aged 20 and older participated, including more than 200 cancer or severe-disease patients and caregivers. Among respondents, 69.5% believed they or a family member could face cancer or a severe disease, and a similar proportion, 69.7%, replied that “accessing new drugs would be difficult.” The biggest barriers were financial burden (54.2%) and lack of information (52.2%). Older respondents perceived the lack of information about new drugs as a greater problem. Among respondents who had personally experienced or had a family member with cancer or a serious illness, 47% considered treatment with new drugs, but 74% of those reported difficulties accessing such treatments. 84% of respondents stated that ensuring accessibility after new drug development is essential for innovation, and 82.7% agreed that if a drug is inaccessible due to cost, it cannot be considered innovative. This indicates that the majority of Koreans perceive pharmaceutical innovation not merely as scientific progress but also as encompassing broader social value. The government (89%) was identified as the most important entity for improving new drug accessibility, followed by healthcare professionals (83.5%) and pharmaceutical companies (64.2%). 70.8% of respondents felt that the role of certain stakeholders was being over-emphasized in the current system, while 87.2% agreed that collaboration among all stakeholders is necessary. Regarding the roles expected of each entity to improve new drug accessibility, the most common response (receiving positive responses from over 80% of respondents) was that the government should secure flexibility in new drug price evaluations and relax/expand reimbursement criteria to broaden coverage. Healthcare professionals needed to provide patients with information on new drugs and disease education, and to assist in selecting optimal treatments through sufficient communication with patients. Pharmaceutical companies needed to contribute to improved accessibility by expanding clinical trials and engaging in reasonable price negotiations. Patient groups needed to lead efforts to improve awareness through sharing patient experiences and advocating for healthcare policy improvements. In-depth interviews conducted to gain deeper insights from the quantitative survey results and derive practical improvement measures revealed that experts from various sectors, government, pharmaceutical industry, patient groups, and media, unanimously agreed that for the innovation of new drugs to truly reach patients, cooperation across systems, industry, and society as a whole must function together. The most urgent issue identified was structural reform of the pricing and reimbursement system. Experts noted that the system remains largely unchanged from 20 years ago and pointed to shortages of trained reviewers and delayed assessment timelines as major bottlenecks. There was broad consensus on the need for a shift toward a reimbursement structure prioritizing severe diseases, improved predictability in pricing evaluation procedures, and greater flexibility to accommodate patient-specific circumstances. Additionally, establishing a sustainable ecosystem for new drug supply was presented as a key task. Emphasis was placed on transparency of data during drug price negotiations, reasonable price negotiations, and responsible efforts by the pharmaceutical industry to prevent market withdrawal due to pricing issues. Lastly, patient-centered decision-making and strengthened public dialogue were deemed necessary. Experts pointed out that the rigid reimbursement criteria limit treatment choices for individual patients, proposing institutional mechanisms to bridge the gap between medical professionals' judgments and patient expectations. They also emphasized the importance of the media and civil society's role in consistently highlighting treatment access issues and fostering public discourse. Ji-yeon Lee, Team Leader of the Business Division at Embrain Research, who oversaw this survey, stated, “This survey confirmed that the public recognizes the innovation of new drugs not just as technological achievements, but as social value that actual patients can tangibly experience. It is time to ‘redefine innovation’ to include not only efficacy but also accessibility, and this public perception needs to be actively reflected in future policy and system improvement discussions.” Jihye Yang, CEO of BeOne Medicine Korea, remarked, “This survey confirms the public's recognition that innovation must be proven in patients' lives, not just in laboratories. The background enabling BeOne Medicine Korea to drive the rapid reimbursement introduction of Brukins and Tevimbra was internalizing clinical development and streamlining operational models. Innovation can reach patients when all stakeholders—the government, healthcare professionals, and patient groups—act and cooperate."
- Company
- ABL Bio shows successful technology transfer…Lilly invests
- by Cha, Jihyun Nov 18, 2025 06:08am
- ABL Bio, a company specializing in bispecific antibodies, successfully secured both a large-scale technology transfer agreement and a strategic investment from Eli Lilly, a global pharmaceutical company. These deals instantly provided the company with over KRW 80 billion in cash reserves. The consecutive deals proved the company's global technological competitiveness, causing the stock price to surge. ABL Bio's market capitalization approximately doubled in just three days, from the KRW 5 trillion range to the KRW 10 trillion range. According to the Korea Exchange (KRX) on November 16, ABL Bio's stock price closed at KRW 174,200, a 6.5% increase from the previous trading day. Earlier that day, ABL Bio briefly broke its 52-week high of KRW 195,500. ABL Bio's stock price surged for three consecutive trading days from the 12th to the 14th. Compared to the closing price of KRW 97,500 on the 11th, ABL Bio's stock price jumped approximately 78.7%. The market capitalization increased from KRW 5.3747 trillion on November 11 to KRW 9.6028 trillion on November 14, based on closing prices. During the day, the market cap peaked at KRW 10.77 trillion. The company's valuation nearly doubled in just three days. ABL Bio climbed to the 4th position by market capitalization on the KOSDAQ as of the November 14 closing price. ABL Bio Analysis suggests that ABL Bio's stock price surge was driven by its consecutive technology-transfer and strategic-investment agreements with Eli Lilly. ABL Bio previously signed a technology transfer and joint research and development (R&D) agreement with Eli Lilly on November 12 for its Blood-Brain Barrier (BBB) shuttle platform, 'Grabody-B'. The deal grants Eli Lilly exclusive worldwide rights to develop and commercialize multiple undisclosed target candidates, applying ABL Bio's Grabody-B platform to various modalities. The total value of the agreement is $2.602 billion (approximately KRW 3.8072 trillion). The non-refundable upfront payment is $40 million (KRW 58.5 billion), representing 1.5% of the total contract value. ABL Bio will receive up to $2.562 billion (approximately KRW 3.7487 trillion) in milestone payments, contingent on clinical, regulatory, and commercialization achievements. Royalties on net sales, if commercialization is successful, are separate. Notably, their agreement is a 'platform deal,' transferring comprehensive rights to develop multi-target therapies using the Grabody-B platform across various modalities, rather than a single candidate molecule. Since a global top-tier pharmaceutical company chose a platform that can be expanded across multiple disease areas and development methods, it is considered significant. ABL Bio previously signed an R&D agreement in April with the global pharmaceutical company GlaxoSmithKline (GSK) to develop neurodegenerative disease treatments using Grabody-B. That agreement was valued at £2.1401 billion (approximately KRW 4.1104 trillion). At the time, ABL Bio also entered a platform agreement with GSK to develop multi-target therapies using various modalities, including siRNA, ASO, and antibodies. This is significant as two global top-tier pharmaceutical companies, GSK and Eli Lilly, have chosen the ABL Bio platform. Summary of ABL Bio Such a platform's competitiveness is further confirmed by Eli Lilly's decision to make a direct equity investment. Two days after the technology transfer announcement, on November 14, ABL Bio announced a capital increase of 3rd-party share allocation worth $15 million (approximately KRW 22 billion) to Eli Lilly, specifically issuing 175,079 common shares at KRW 125,900 per share. The common shares issued in this transaction will be held in escrow at the Korea Securities Depository for one year. ABL Bio plans to invest the secured funds in R&D, specifically advancing Grabody-B and developing bispecific antibody-drug conjugates (ADCs). ABL Bio also announced its goal to use this investment to strengthen its new drug development capabilities and explore diverse opportunities for collaboration with Lilly for new drug development from a long-term perspective. This investment is particularly noteworthy because it is a strategic investment made separately from the technology transfer agreement, suggesting that Eli Lilly highly values the commercial potential and long-term partnership value of the Grabody-B platform. The fact that the same partner decided to make a consecutive strategic equity investment immediately after a technology transfer agreement is a rare event in the Korean biotech industry. The market views this as evidence that ABL Bio's BBB shuttle platform has been recognized as competitive on the international stage. Consequently, ABL Bio has immediately secured over KRW 80 billion in cash reserves, combining the KRW 58.5 billion upfront payment from the Grabody-B technology transfer with Lilly and the KRW 22 billion from the capital increase. Including the KRW 73.9 billion upfront payment from the GSK platform technology transfer in April, ABL Bio has secured over KRW 150 billion in cash reserves from global big pharma companies this year alone. ABL Bio is establishing a virtuous cycle by reinvesting funds generated from successive strategic investments and technology-transfer revenues into R&D. ABL Bio recently officially launched its U.S. local subsidiary, Neok Bio, to strengthen its global clinical system. Neok Bio is a company dedicated to the clinical development of bispecific ADC candidates. It will serve as a worldwide clinical hub, responsible for communication with U.S. regulatory authorities, conducting bispecific ADC clinical trials, and formulating development strategies.
