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- 2026-07-22 03:12:21
- Company
- Biogen Korea appoints Chul Woong Kim as new GM
- by Eo, Yun-Ho Jul 08, 2026 08:54am
- The leadership vacancy at Biogen Korea, which had remained unfilled since the resignation of former GM Se-Eun Hwang, is finally set to be filled.According to industry sources, Biogen Korea has recently appointed Chul Woong Kim, Director of the Rare Disease Business Unit at AstraZeneca Korea, as its new General Manager. He is expected to officially join Biogen later this month.Biogen Korea has operated without a head for approximately four months following Hwang's sudden resignation in February. The former GM subsequently joined CSL Korea as its new head in March.Kim earned his bachelor's degree in International Trade from Dongguk University and completed an MBA at Yonsei University's Graduate School of Business. He is a seasoned rare disease expert with more than 20 years of experience across domestic and global pharmaceutical companies, spanning sales, marketing, brand strategy, and business unit management.Kim began his pharmaceutical career at Eli Lilly Korea before leading the hemophilia and rare disease business at Pfizer Korea. He later assumed a regional leadership role based in Hong Kong, overseeing rare disease strategy across Emerging Markets in Asia. Since 2022, he has served as Business Unit Director of AstraZeneca Korea's Rare Disease Business Unit, leading the company's rare disease operations in Korea.
- Policy
- Salt-modified Forxiga IMDs secure reimbursement in Korea
- by Jung, Heung-Jun Jul 08, 2026 08:54am
- Forxiga generics continue to enter the reimbursement market following the original product’s market withdrawal in 2024With generic versions of the original Forxiga (dapagliflozin) showing a continued rise in sales, companies continue to enter the Forxiga market.Among them, one product has secured pricing advantages by switching from contract manufacturing to in-house production, further intensifying competition.According to industry sources on the 6th, Withus Pharmaceutical's Posijin Tab (dapagliflozin citrate) 5 mg and 10 mg were added to the National Health Insurance reimbursement list this month. Having satisfied all pricing criteria, the products were listed at KRW 262 and KRW 393, respectively.Posijin carries the same brand name as a dapagliflozin product that Withus originally obtained marketing approval for in 2020. At that time, the product was manufactured under contract by Sam Chun Dangg Pharm, but its approval was voluntarily withdrawn in October 2024.The newly listed ‘Posijin Tab,’ despite sharing the same brand name, differs from its predecessor in that it uses a modified salt form. In addition, it was developed through the company's own bioequivalence study rather than contract manufacturing, allowing it to satisfy all pricing requirements. It obtained regulatory approval in April this year and secured reimbursement just four months later.Although it retains the same product name as the previously withdrawn version, the new Posijin differs in that it now fulfills all requirements for pricing advantages. It also expands the reimbursed product lineup by offering an additional 5 mg strength, which was not available in the previous version.A Withus Pharmaceutical official said, "We pursued this strategy because in-house manufacturing offers pricing advantages. There was no other special reason," expressing expectations that the product will contribute to sales growth following the company’s full-scale marketing activities.Sales of Forxiga generics have continued to increase following AstraZeneca Korea's voluntary withdrawal of the original product from the domestic market in 2024, with generic manufacturers benefiting from the resulting market opportunity.Among generic manufacturers, HK inno.N, Boryung, Daewoong Bio, and Hanmi Pharmaceutical have emerged as the leading competitors in sales.According to pharmaceutical market research firm UBIST, HK inno.N's Dapa N recorded sales of KRW 10.5 billion, representing 341% growth from KRW 2.4 billion the previous year. Boryung's Truedapa posted KRW 5.6 billion, up 19% year over year. Sales of Daewoong Bio's Forxidapa increased from KRW 2.3 billion to KRW 6.0 billion, a 157% increase, while Hanmi Pharmaceutical's product grew from KRW 4.0 billion to KRW 5.8 billion, representing 45% growth.However, competition among SGLT-2 inhibitor monotherapy generics has become even more complex after a large number of Jardiance (empagliflozin) generics entered the market following patent expiration in the fourth quarter of last year.
- Policy
- Medical cannabis restricted under outdated narcotics regulations
- by Lee, Jeong-Hwan Jul 08, 2026 08:53am
- Product photo of EpidiolexBoth the ruling and the opposition parties in South Korea are introducing bills to permit the domestic commercialization and marketing authorization of medical cannabis that offers validated clinical efficacy without psychoactive or addictive risks, such as cannabidiol (CBD). This would increase the likelihood of bypassing long-standing regulatory bottlenecks for treatment access for patients, such as those with epilepsyIf enacted, the legislation will improve South Korea's outdated Narcotics Control Act, which previously failed to distinguish non-psychoactive CBD from psychoactive tetrahydrocannabinol (THC). This regulatory reclassification is anticipated to bring a regulatory shift within the conservative Ministry of Food and Drug Safety (MFDS).On the 6th, Rep. Hyungdong Kim of the People Power Party submitted a bill that reclassifies medically viable cannabis derivatives as psychotropic substances. By clarifying the definition of cannabis, the amendment enables pharmaceutical companies to apply for domestic manufacturing and marketing authorizations.Earlier in March, Rep. Mihwa Seo of the Democratic Party of Korea introduced a separate amendment to the Narcotics Control Act with a similar regulatory intent.Globally, regulatory bodies have increasingly removed CBD-based therapeutics from restricted narcotics schedules, facilitating commercial product development and expanding patient care. In contrast, the South Korean MFDS has restricted access solely to personal-use imports handled via the Korea Orphan & Essential Drug Center (KODC), under the rationale that full commercial legalization could precipitate widespread substance abuse. Consequently, patients with intractable epilepsy continue to face severe therapeutic limitations. At present, Epidiolex, an orphan therapeutic indicated for rare pediatric-onset epilepsies, remains the only medical cannabis-derived pharmaceutical authorized for use in South Korea.Although Epidiolex relies entirely on imports, its reimbursement status has significantly reduced out-of-pocket expenses for patients. However, the remaining premium cost is borne entirely by national health insurance fiscal reserves, impacting state healthcare expenditure.Ultimately, the current law must be amended before the patent expiration of Epidiolex. Aligning domestic CBD regulations with international standards would enable domestic generic drug manufacturers to initiate bioequivalent CBD generics, thereby conserving national health insurance resources. This strategic commercial and fiscal implication explains why the pharmaceutical sector is closely tracking the legislative proposals introduced by Representatives Kim and Seo. Rep. Kim’s proposed bill classifies medically viable cannabis derivatives as psychotropic medicines. It also expands the statutory definition of a cannabis cultivator to allow cultivation intended for supplying raw materials to licensed narcotics manufacturers for pharmaceutical production, moving beyond traditional fiber or seed harvesting constraints, subject to explicit authorization from the Minister of the MFDS.Rep. Kim’s proposed bill strictly prohibits the handling or distribution of cannabis-derived psychotropics that deviate from supply chain compliance standards mandated by Presidential Decree, establishing stringent penalties for non-compliance. Furthermore, cultivators producing cannabis for pharmaceutical manufacturing are required to report total acreage, operational status, and harvest yields to the MFDS Minister under Prime Ministerial Decrees, with a mandatory clause dictating that any crop volume exceeding predefined supply contracts must be destroyed and formally documented.Additionally, the bill mandates the creation of a specialized institute, the "Medical Narcotics Raw Material Management Center", to secure active pharmaceutical ingredients (APIs) and oversee safety compliance. This center will monitor designated cultivation zones and manage annual cultivation supply agreements with licensed growers for downstream pharmaceutical formulation.The legislative objective is to establish a highly regulated, government-controlled supply chain tracking everything from raw crop cultivation through extraction, purification, active ingredient manufacturing, and raw material volume allocation.An official from the National Assembly's Health and Welfare Committee note, "The swift passage of the Narcotics Control Act amendment, along with supportive government initiatives to localize CBD oil production, would effectively prevent fiscal loss from national health insurance resources while significantly expanding therapeutic options for patients with intractable conditions like epilepsy," and added, "The bill encompasses both the clinical optimization and national health security."Meanwhile, following the introduction of this bill, Rep. Kim plans to host a policy forum on the 7th at the National Assembly Representatives Office Building to continue discussions under the theme "Strategies for Introducing Cannabis-Derived Pharmaceuticals to Expand Therapeutic Options for Rare·Intractable Disease Patients and Secure Essential Medicine Supply Chains".
- Company
- Samsung Bioepis gains edge in Keytruda biosimilar race
- by Hwang, byoung woo Jul 08, 2026 08:53am
- Samsung Bioepis’ headquartersSamsung Bioepis has taken the lead in the race to develop a biosimilar to the blockbuster immuno-oncology drug Keytruda, becoming the first company to disclose Phase III clinical data.With the patent expiration of Keytruda, which has exceeded $30 billion in global sales, approaching, it is assessed that Samsung Bioepis has established the foundation for a follow-up approval strategy targeting the large-scale immuno-oncology biosimilar market by leveraging its extensive clinical data.Secures ‘Phase III data… differentiates regulatory positioningSamsung Bioepis recently announced that SB27, its Keytruda biosimilar candidate, met the primary efficacy endpoints in both global Phase I and Phase III clinical studies, demonstrating equivalence to the original product.The Phase I trial enrolled 163 participants across four countries, including South Korea. The company reported that pharmacokinetic analyses of the area under the plasma level-time curve (AUC) met the predefined equivalence criteria.The Phase III trial enrolled 555 patients in 14 countries. In patients with non-small cell lung cancer (NSCLC), SB27 demonstrated efficacy equivalent to the reference product based on the objective response rate (ORR) at Week 24, the study's primary endpoint. Comparable safety and immunogenicity profiles were also observed.The significance of these findings lies in Samsung Bioepis becoming the first developer to present topline results from a global Phase III study in the Keytruda biosimilar race, thereby securing clinical evidence that could strengthen its regulatory competitiveness. By completing both global Phase I and Phase III studies, the company has assembled a comprehensive clinical package expected to enhance its position during future regulatory review and commercialization.According to the company, both clinical studies are scheduled to be fully completed within this year. However, completion of the trials does not necessarily mean regulatory submissions or product launch will occur within the same timeframe.Even after clinical completion, biosimilar approval requires additional steps, including data collection and analysis, preparation of regulatory data, and development of country-specific submission strategies.USD 31.7 billion market fuels intensifying competitionThe fierce competition surrounding Keytruda biosimilars reflects the enormous size of the original’s market. According to MSD's 2025 financial results, combined annual sales of Keytruda and the subcutaneous formulation Keytruda Qlex reached USD 31.7 billion (approximately KRW 46 trillion), making it one of the world's highest-selling pharmaceutical products.Keytruda is a PD-1 immuno-oncology drug indicated for a wide range of cancers, including non-small cell lung cancer, melanoma, and head and neck cancer, giving it a broad treatment base and substantial prescribing volume.Given the product's commercial value, multiple developers are racing to develop biosimilars. The compound patent is scheduled to expire sequentially beginning in 2028 in Korea, 2029 in the United States, and 2031 in Europe, intensifying global competition to secure early market entry.Celltrion is conducting a global Phase III trial of its Keytruda biosimilar CT-P51, while China's Bio-Thera Solutions has initiated an integrated Phase I/III study of BAT3306. Other global biosimilar developers, including Formycon and Sandoz, are also pursuing pembrolizumab biosimilars.Samsung Bioepis' key advantage lies in having completed both global Phase I and Phase III studies, providing a robust clinical evidence package that goes beyond the minimum regulatory requirements and is expected to strengthen physician trust.MSD’s KeytrudaThis is particularly meaningful because large immuno-oncology biosimilars require complex trial designs and extensive patient recruitment. Demonstrating success in both Phase I and Phase III studies is expected to carry significance in future regulatory submissions and partnership discussions.Another noteworthy development is the evolving regulatory strategy among competitors. As the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) move toward streamlining biosimilar approval requirements, companies such as Sandoz and Formycon have discontinued Phase III trials and are instead pursuing regulatory approval based solely on Phase I data.While Samsung Bioepis benefits from having completed conventional global Phase I and Phase III studies, some competitors may seek approval through these alternative regulatory pathways under the evolving framework.Nevertheless, because Samsung Bioepis adopted an overlapping strategy by initiating Phase I and Phase III studies simultaneously, its extensive efficacy and safety data from a large-scale Phase III trial are expected to serve as a major competitive advantage in the prescription conservative oncology market, building physician trust and supporting future market penetration.Another challenge will be overcoming MSD's evergreen strategy aimed at extending the commercial life of Keytruda. To defend against biosimilar competition, MSD is actively transitioning patients from the intravenous (IV) formulation to a more convenient subcutaneous (SC) formulation, pursuing regulatory approvals in major markets in an effort to contain as many patients as possible before biosimilars become available.For Samsung Bioepis, successful commercialization will depend not only on regulatory approval timelines but also on product differentiation, manufacturing and supply capabilities, reimbursement and tender strategies in individual markets, and commercial partnership capabilities.The company stated that it is still too early to disclose specific launch plans or commercialization strategies for SB27.However, because patent expiry is expected earlier in Korea than in many other markets, industry observers believe the product could potentially be launched first in Korea in 2028. However, the actual launch timing will ultimately depend on regulatory review, patent litigation, and market conditions in each country.Dong-hoon Shin, Executive Vice President of Clinical Science at Samsung Bioepis, said, "Demonstrating equivalence between SB27 and the reference product represents a meaningful achievement that showcases Samsung Bioepis' global biosimilar development capabilities. Building on our rigorous quality management system, we will continue to strive to improve patient access to immuno-oncology therapies through biosimilars."
- Company
- Lynparza secures long-term survival evidence in ovarian cancer
- by Son, Hyung Min Jul 08, 2026 08:53am
- PARP inhibitor 'Lynparza (olaparib)' The evaluation criteria for first-line maintenance therapy in ovarian cancer is shifting.Delaying disease recurrence, progression-free survival (PFS), and overall survival (OS) improvements are now included as primary endpoints for assessing therapeutic efficacy, underscoring the growing importance of initiating early-stage treatment strategies optimized for long-term prognosis.According to biopharmaceutical industry sources, recent global clinical guidelines are increasingly prioritizing biomarker-based personalized medicine for the ovarian cancer therapy.As treatment strategies become increasingly subdivided, targeting patients with BRCA mutations to those with homologous recombination deficiency (HRD), the clinical value of first-line maintenance therapies backed by long-term survival data has increased. Consequently, the therapeutic strategy is shifting toward subdividing treatment pathways based on patient-specific biomarker profiles to maximize the likelihood of modifying long-term prognosis from the initial maintenance therapy. Amid these clinical shifts, the PARP inhibitor 'Lynparza (olaparib)' is being assessed as a therapeutic option with long-term follow-up data across both BRCA-mutated and HRD-positive patients from the SOLO-1 and PAOLA-1 trials, respectively.Ovarian cancer has the highest mortality rate among all gynecological malignancies. A significant majority of patients are diagnosed at an advanced stage. Despite high initial response rates to frontline interventions, the clinical course is characterized by frequent recurrences, followed by sequential rounds of subsequent lines of therapy. Given these clinical challenges, real-world oncology practice is rapidly shifting toward maintenance strategies that prioritize overall survival (OS) outcomes alongside progression-free survival. The SOLO-1 study has proved Lynparza's effectiveness as a first-line maintenance therapy for BRCA-mutated ovarian cancer. At the 3-year follow-up analysis, the progression-free survival rate was 60% in the Lynparza group, compared with 27% in the placebo arm, demonstrating a 70% reduction in the risk of disease progression or death. Subsequent 7-year follow-up data provided evidence of long-term survival. The overall survival rate in the Lynparza group was confirmed at 67%, a 45% reduction in the risk of death compared to the placebo control (mOS: NR vs. 75.2 months). This indicates that 2 of 3 patients survived to the 7-year mark, validating that the survival benefit of frontline Lynparza maintenance therapy is sustained over extended follow-up. In addition to the BRCA-positive patients, Lynparza demonstrated a consistent overall survival benefit in patients with HRD-positive status.In the 5-year follow-up analysis of the PAOLA-1 clinical trial, the 5-year overall survival rate among HRD-positive patients was 65.5% in the Lynparza + bevacizumab combination therapy group versus 48.4% in the bevacizumab monotherapy group, translating to a 38% reduction in the risk of death. Within the same analysis, the median progression-free survival reached 46.8 months and 17.6 months, respectively, representing a 59% reduction in the risk of disease progression or death. The significance of the PAOLA-1 5-year data extends beyond merely securing additional long-term tracking points. Demonstrating a statistically significant overall survival benefit in the first-line maintenance setting is difficult in ovarian cancer clinical trials, as the data are highly susceptible to confounding by multiple sequential lines of subsequent therapies administered after recurrence. This trial demonstrated that the Lynparza + bevacizumab combination therapy maintains a highly consistent clinical benefit for HRD-positive patients over an extended long-term follow-up period, consistent with the efficacy seen in the initial primary analyses.Notably, the long-term follow-up study results of sustained PFS, alongside enhanced 5-year survival rates and reduced mortality risk, provides significant evidence supporting the clinical value proposition of this therapeutic strategy. This outcome confirms that frontline maintenance product selection directly correlates with downstream long-term prognostic outcomes. Homologous recombination deficiency represents a critical biomarker detected in approximately half of all patients with high-grade serous ovarian cancer, the primary histological subtype of the disease. As the ovarian cancer treatment paradigm transitions into biomarker-based precision oncology, the clinical weight of mature long-term survival evidence generated within the HRD-positive population has risen substantially.This clinical evidence is firmly reflected in international therapeutic standards. The National Comprehensive Cancer Network (NCCN) Guidelines recommend Lynparza following platinum-based chemotherapy in both BRCA-mutated and HRD-positive cohorts. Notably, within the HRD-positive population, the Lynparza plus bevacizumab combination therapy is the only PARP inhibitor-based therapy designated as a Category 1 recommendation.Despite strong clinical evidence and inclusion in standard global guidelines, patient market access bottlenecks persist in South Korea. While health insurance coverage is active for the BRCA-mutated cohort, the Lynparza-bevacizumab combination based on the PAOLA-1 trial for HRD-positive patients remains non-reimbursed. Although the therapy cleared the initial regulatory hurdle at the Cancer Disease Review Committee (CDRC) in September of last year, final implementation of the expanded reimbursement criteria has been delayed for nearly a year. Consequently, oncologists emphasize that even when companion diagnostic HRD screening identifies patients who would derive clinical benefit, financial barriers prevent the deployment of this optimized first-line maintenance strategy in real-world clinical practice.Discussions about the need to expand reimbursement for Lynparza have intensified recently. "The 2nd National Health Insurance Comprehensive Plan," finalized in March, includes provisions to review expanded reimbursement criteria for oncology therapeutics utilized in ovarian cancer care. Simultaneously, calls for improving patient access continue to gain traction across regulatory policy forums and academic symposia. Professor Se Ik Kim of the Department of Obstetrics and Gynecology at Seoul National University Hospital said, "Given that ovarian cancer carries a high recurrence rate requiring repetitive lines of sequential therapy, it is imperative to establish frontline strategies focused on maximizing long-term survival probability from the outset. Rather than simply delaying time-to-recurrence, clinical management must increasingly prioritize therapeutic strategies that optimize long-term prognosis by integrating patient-specific biomarker characteristics."Professor Kim added that Lynparza is a PARP inhibitor with mature, long-term survival data across both BRCA-mutated and HRD-positive populations from the SOLO-1 and PAOLA-1 trials. He emphasized that it is highly clinically meaningful because it demonstrates that frontline maintenance product selection in the HRD-positive population can significantly dictate downstream, long-term therapeutic outcomes. Professor Kim concluded by emphasizing that "While clinicians can now screen and identify patients expected to benefit clinically via companion HRD testing, patient access to treatment remains restricted. We expect that discussions on patient access advance rapidly so that clinically validated therapeutic strategies can be applied to real-world patient care. "
- Opinion
- "We must discuss the protective efficacy of flu shots for seniors"
- by Son, Hyung Min Jul 07, 2026 08:58am
- "Given that the current policy's strength lies in expanding vaccination rates, the future challenge is to enhance protective efficacy. It is now time to discuss not only vaccination coverage but also focus on which vaccines can provide more substantial protection for the elderly; in other words, discussing the 'quality of protection'."Professor Min Joo Choi of the Division of Infectious Diseases at Korea University Guro Hospital Professor Min Joo Choi of the Division of Infectious Diseases at Korea University Guro Hospital proposed this direction for influenza immunization policies for the elderly.Influenza is a major respiratory infectious disease, causing 3 to 5 million cases of severe illness and up to 650,000 deaths globally each year. In particular, older adults aged 65 and above are classified as a high-risk group facing the highest jeopardy of hospitalization, severe complications, and mortality. In South Korea, approximately 70% of influenza-related hospitalizations and over 80% of associated deaths are concentrated among the elderly, whose healthcare expenditure burden also ranks as the highest across all age demographics.Despite high vaccination rates, the disease burden among older adults remains significant. Due to immunosenescence, the antibody-producing capacity of the elderly post-vaccination is known to range from 40% to 80% of that seen in healthy adults. This implies that conventional standard-dose vaccines may fail to elicit a sufficient immune response in this cohort.Major developed countries, including the United States, the United Kingdom, and Australia, already preferentially recommend adjuvanted or high-dose influenza vaccines over standard-dose formulations for individuals aged 65 and older. The Korean Society of Infectious Diseases (KSID) also aligned with this direction in its 2023 adult immunization guidelines.Related to this issue, Professor Choi conducted a comparative study evaluating the cost-effectiveness of an MF59-adjuvanted quadrivalent influenza vaccine (aQIV) among older adults aged 65 and older in South Korea and Taiwan. The findings were recently published in the international peer-reviewed journal Vaccine. The study carries significant clinical and economic weight as a domestic research study concurrently evaluating the clinical efficacy and pharmaco-economic profiles of advanced senior vaccine strategies. Cost-effectiveness and health benefits…what's the significance of this economic analysis?Regarding the implications of the economic analysis spanning cost-effectiveness and health utilities, the study revealed that although the adjuvanted vaccine incurs higher upfront acquisition and administration costs than standard-dose options, it represents a highly cost-effective intervention when accounting for downstream medical cost savings from reductions in influenza-related hospitalizations, complications, and mortality.Notably, transitioning from standard-dose to adjuvanted vaccines yielded an Incremental Cost-Effectiveness Ratio (ICER) of $2,200 per Quality-Adjusted Life-Year (QALY). This figure sits vastly below the standard domestic willingness-to-pay (WTP) threshold, which is typically tied to South Korea's per capita Gross Domestic Product (GDP) of approximately $36,130. This demonstrates that the derived health utilities significantly outweigh the incremental vaccination expenditures."Our analysis indicates that while acquisition costs increase compared to standard-dose vaccines, a substantial portion of this incremental cost is offset by the mitigation of downstream expenses associated with hospitalizations, complications, and deaths," Professor Choi stated. "We have confirmed that the health benefits gained relative to the added expenditure are highly substantial." Cost-effectiveness analysis does not simply compare acquisition prices across vaccine products; rather, it is a health economics methodology that evaluates the holistic value of an immunization strategy by incorporating medical cost offsets alongside quality-of-life improvements derived from a lower burden of preventable infections, clinical complications, hospitalizations, and deaths.This study included the specific demographic structures, vaccine coverage rates, and healthcare utilization patterns of the elderly cohorts in both South Korea and Taiwan, confirming the stability and robustness of the outcomes through exhaustive sensitivity and scenario analyses. The parameters exerting the greatest influence on the final health economic outcomes were relative vaccine effectiveness (rVE) and vaccine pricing."Even within our sensitivity analyses, relative vaccine effectiveness emerged as the most critical variable, while vaccine cost also exerted a major influence on the overall economic outcomes," Professor Choi explained.However, Professor Choi urged caution when interpreting comparisons against high-dose influenza formulations."Although our current study reports the adjuvanted vaccine as a cost-saving strategy, evidence directly comparing the two enhanced formulations remains limited," Professor Choi noted. "Any comparative projections against the high-dose vaccine should be viewed as purely exploratory. The significance of this research lies in validating the distinct clinical and economic value proposition of the adjuvanted vaccine over standard-dose options."Analysis expands beyond disease burden to economic viabilityThis analysis serves as a sequential follow-up expanding upon the senior influenza immunization strategy research published by Professor Choi in 2022.In that preceding study, the clinical burden of disease, including total infections, complications, hospitalizations, and deaths, was compared across standard-dose quadrivalent, high-dose quadrivalent, and adjuvanted quadrivalent vaccine strategies targeting the domestic elderly population aged 65 and above. Historical data demonstrate that immunization strategies using enhanced-immunogenicity formulations can substantially reduce the clinical burden of disease in older adults.To discuss an actionable immunization policy, evidence that extends beyond isolated clinical efficacy is required. To integrate an advanced vaccine strategy into national public health frameworks such as the National Immunization Program (NIP), a robust pharmaco-economic evaluation is concurrently mandatory to substantiate the health utilities generated relative to the incremental fiscal investment."At the time of our 2022 study, real-world clinical experience with adjuvanted and high-dose vaccines within South Korea was highly constrained, and there was significant uncertainty surrounding product pricing, which is a critical variable in any health economic assessment," Professor Choi stated. "As a result, executing a highly reliable cost-effectiveness analysis was technically challenging back then."Professor Choi added, "As these advanced formulations subsequently became commercially accessible in South Korea, we were able to establish highly realistic pricing assumptions, which ultimately provided the foundation for this comprehensive study."The study's distinguishing feature is conducting parallel analyses of both South Korea and Taiwan. While historical economic models have predominantly focused on Western populations across North America and Europe, this research actively incorporates the specific demographic architecture and healthcare realities of two prominent Asian nations transitioning into super-aged societies."Although South Korea and Taiwan present distinct variations in senior demographics, influenza epidemiology, and healthcare utilization patterns, both nations share the critical commonality of being super-aged societies," Professor Choi evaluated. "This study bridges the gap in Western-centric data, providing concrete evidence to guide immunization policies that reflect the unique epidemiological characteristics and healthcare environments of the Asian region." The need to expand immunization strategies centering around elderlyProfessor Choi clarified that, because the research evaluated the general senior population aged 65 and older, the outcomes are not limited to narrow sub-segments of ultra-high-risk patients. However, she noted that these baseline analytical insights for the broader elderly cohort can serve as a foundational benchmark for future discussions regarding risk-stratified or risk-based vaccination paradigms."The strategic center of gravity for public health policies must transition from merely boosting raw coverage rates toward preventative strategies that actively minimize hospitalizations and severe clinical complications," she emphasized. "Over the long term, we require immunization frameworks that evaluate chronological age in tandem with individual patient risk profiles."She further noted, "If the defining achievement of our current policy is vaccination expansion, our upcoming project must be the optimization of protective efficacy. We have reached a critical junction where public health discussion should extend past quantitative uptake metrics to focus on qualitative clinical protection; specifically, identifying which vaccine platforms offer sufficient protection for our aging population." To date, South Korea’s elderly influenza immunization policy has achieved significant operational success in terms of quantitative coverage. Driven by the National Immunization Program (NIP), vaccine accessibility for older adults aged 65 and above has been significantly enhanced, maintaining high population-wide uptake rates.However, elevated coverage rates do not automatically eliminate the clinical burden of disease among seniors. Due to immunosenescence, older individuals frequently exhibit suboptimal immune responses following vaccination, leaving them vulnerable to post-vaccination breakthrough infections, influenza-related hospitalizations, and secondary complications. Public health experts confirm that despite robust clinical uptake, the burden of severe morbidity and hospitalization within the senior demographic remains a critical public health challenge. Professor Choi suggested that policymakers could explore a phased expansion of the prioritized immunization cohort to include adults aged 50 to 64. This specific demographic represents a lifecycle phase in which the prevalence of chronic underlying comorbidities begins to climb, making early reinforcement of preventive strategies prior to advanced age a highly rational policy consideration.In addition, Professor Choi proposed integrating adult vaccinations within the formal National Health Insurance (NHI) reimbursement as a key long-term project.Professor Choi noted, "Currently, systematically tracking adult vaccination rates alongside real-world effectiveness remains challenging. We must establish a tracking infrastructure utilizing national health insurance claims databases to evaluate immunization status and clinical real-world outcomes continuously." Professor Choi concluded by suggesting that "We need to design precision-targeted adult immunization policies based on accumulated real-world data."
- Company
- KCSOA makes a 3rd attempt to secure incorporation
- by Kim, Jin-Gu Jul 07, 2026 08:57am
- Korea Contract Sales Organization Association (KCSOA)The Korea Contract Sales Organization Association (KCSOA) is attempting a third time to secure official incorporation from regulatory authorities. Industry insiders indicate that the primary hurdle to obtaining approval will depend on the association's ability to recruit "solo-operator CSOs", individual entrepreneurs, and freelancers who currently represent more than 70% of all registered Contract Sales Organizations (CSOs) in South Korea.According to biopharmaceutical industry sources on the 6th, KCSOA is actively preparing to apply for official corporate body status. The association is reportedly refining its articles of incorporation and strategic business plans, which the Ministry of Health and Welfare (MOHW) cited as deficiencies in two prior rejections. KCSOA aims to finalize its organizational restructuring, including the appointment of a new executive board, within this month before resubmitting its formal application for incorporation to the MOHW in the second half of this year.This round of attempt is largely attributed to a shifting regulatory stance within the MOHW. The ministry recently acknowledged the need to establish an official communication channel with the CSO sector, expressing alignment with the fundamental need for a formalized association. However, the regulatory body also maintained a strict stance on statutory compliance, clarifying that it will evaluate any resubmission in strict accordance with relevant administrative regulations once the previously insufficient documentation is completely rectified.Industry analysts note that securing corporate body status is a foundational step toward expanding KCSOA’s official mandate. Once recognized as a legal entity by the MOHW, the association can serve as an accredited counterparty for government consultations. This would enable the organization to systematically drive industry-wide continuing education, regulatory policy initiatives, and self-regulatory compliance programs on behalf of the sector. Both the ministry and the industry share a consensus on the urgency of an official representative body as administrative demands rise, driven by mandatory compliance workflows such as annual 8-hour continuing education requirements, spend transparency reporting, and the oversight of multi-tier consignment and re-consignment contracts. 'Industry representativeness' is a critical benchmark for achieving official incorporation. During the administrative review process for non-profit organizations, a pivotal evaluation factor is whether the applicant represents the broader sector comprehensively, rather than disproportionately favoring a specific sub-segment or a select group of corporate entities.In particular, bringing solo-operator CSOs is considered the decisive variable in establishing true industry-wide representation. Since the implementation of the mandatory CSO Registration System in October 2024, approximately 15,000 entities have secured registration certificates from local municipal governments. Both state regulators and market insiders estimate that roughly 70% of these registrations (equivalent to nearly 10,000 operators) comprise individual business owners or freelancers acting as solo CSOs.However, significant practical barriers remain, as the association's current membership architecture is heavily weighted toward larger corporate CSOs. In standard pharmaceutical promotion models, a drug manufacturer enters into a primary consignment contract with a corporate CSO, which subsequently subcontracts operational volume to independent solo CSOs through reconsignment agreements. Because solo operators rely directly on corporate CSOs for their project pipelines, market analysts suggest that these independent freelancers see little tangible commercial incentive to join the association. The perception that membership yields minimal practical advantages while increasing administrative burdens also impedes the recruitment of individual members. A biopharmaceutical industry source noted that individual freelancers often display aversion to formalizing their status or exposing their identities through association registries. The source added that concerns over membership fees, coupled with apprehensions that individual voices might be marginalized within a corporate-dominated governance structure, further exacerbate this resistance.Despite these hurdles, voices within the CSO sector consistently maintain that establishing an official, recognized association is essential to the industry’s long-term evolution. The CEO of another prominent CSO noted, "The MOHW's shifting stance on the necessity of a formalized association is a highly welcome development. An official incorporation will empower the organization to fulfill its intended institutional mandates," and added, "There is strong consensus within the CSO community to cultivate a clean, compliant distribution ecosystem."The CEO further stated, "The outcome depends on how successfully the association can integrate solo CSOs into the institutional framework," and added, "A failure to encourage individual membership will inherently restrict both the legal representativeness and the association's self-regulatory capabilities."The CEO added, "To my knowledge, previous rejections were primarily affected by quantitative shortfalls such as total membership headcount and asset thresholds," and concluded, "MOHW should evaluate the association's qualitative operational capabilities and its institutional commitment to compliance alongside headcount and membership fee size."
- Company
- Vadanem gains clinical evidence in renal anemia
- by Son, Hyung Min Jul 07, 2026 08:57am
- Treatment strategies for renal anemia in patients with chronic kidney disease (CKD) are expanding beyond conventional erythropoiesis-stimulating agents (ESAs) toward more individualized approaches based on patient characteristics.In particular, growing attention is being paid to the role of hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) in patients with ESA hyporesponsiveness or disordered iron metabolism, prompting active discussion on how these agents can be incorporated into clinical practice based on accumulating real-world clinical evidence.At the 46th Annual Meeting of the Korean society of Nephrology (KSN 2026) held by the Korean society of Nephrology in Seoul, a symposium highlighted the practical potential of Vadanem (vadadustat) based on the latest clinical evidence and real-world experience in the treatment of renal anemia.Speakers from Japan, Korea, Canada, and Taiwan shared the latest evidence on HIF-PHIs, evolving treatment paradigms, and country-specific clinical experience. The presentations focused on the clinical value of Vadanem and its use in practice.Renal anemia develops as CKD progresses, leading to a decrease in the production of endogenous erythropoietin (EPO) and is frequently accompanied by functional iron deficiency associated with inflammation. Consequently, some patients exhibit hyporesponsiveness, showing insufficient response to existing ESA therapy, which raises the need for new treatment strategies.Professor Masaomi Nangaku, The University of TokyoProfessor Masaomi Nangaku of The University of Tokyo presented results from a post hoc win statistics analysis of the INNO2VATE study, which enrolled patients receiving maintenance hemodialysis.The professor introduced results of the win statistics analysis comparing Vadanem with darbepoetin alfa. It used a hierarchical approach that prioritized clinically meaningful outcomes such as death and hospitalization. Results showed that Vadanem reduced the risk of death or hospitalization compared with darbepoetin alfa in analyses covering both the overall study period and the treatment period.Professor Nangaku said, “Vadanem demonstrated consistent non-inferiority to conventional ESA therapy with respect to major adverse cardiovascular events (MACE) regardless of patients' age, sex or geographic region.”He also suggested that the therapy may be particularly useful in patients with ESA hyporesponsiveness, elevated C-reactive protein (CRP) levels indicating inflammation, or reduced glomerular filtration rate (GFR).Prof. Sungjin Chung, Yeouido St. Mary's Hospital, who presented as a Korean expert, added that many dialysis patients in routine clinical practice still fail to achieve target hemoglobin (Hb) levels despite adequate ESA therapy or require repeated dose escalation in Korea."In these patients, treatment strategies should consider ESA hyporesponsiveness or resistance, creating a greater role and need for new therapeutic options.”Professor Chung added, “A meta-analysis of 10 randomized controlled trials (RCTs) demonstrated that Vadanem achieved comparable hemoglobin correction and maintenance to darbepoetin alfa, while maintaining a similar safety profile.Furthermore, based on its mechanism of regulating iron absorption, transport, and utilization through the HIF pathway, it is expected to improve iron utilization by reducing hepcidin. Also, its ability to induce physiological erythropoietic responses was presented as a clinical advantage.During the panel discussion, experts also discussed the long-term safety of HIF-PHIs and their potential role in future treatment strategies.The panel noted that concerns regarding malignancy and thromboembolic events reported with certain HIF-PHIs should not be generalized to the entire class. Instead, treatment decisions should consider the characteristics of individual agents and appropriate patient management.The experts further observed that although the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines currently recommend ESA therapy as the preferred initial treatment, continued accumulation of clinical evidence and long-term safety data could establish HIF-PHIs as an important therapeutic option in the future.They also suggested that HIF-PHIs are likely to expand treatment options by diversifying treatment strategies according to patient characteristics, rather than simply replacing ESA.Tanabe Pharma Korea said, "KSN 2026 is an important venue where the latest findings and innovative treatment methods in the field of nephrology from around the world are shared. Based on a solid partnership with the Korean Society of Nephrology, we will spare no effort for medical advancement and the promotion of human health.”
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- Prescription drug approvals hit 3-year high in 1H 2026
- by Chon, Seung-Hyun Jul 07, 2026 08:57am
- The number of prescription drug approvals in Korea reached a three-year high in the first half of 2026, reflecting pharmaceutical companies' active efforts to expand their product portfolios and enter new markets. There are also some analyses that many companies accelerated regulatory filings to secure reimbursement at higher prices before generic pricing reforms take effect in August. Although approvals rebounded during the first half of this year, the total remains more than 70% lower than 6 years ago following tighter pricing and regulatory policies introduced since 2020.According to the Ministry of Food and Drug Safety (MFDS), 499 prescription drugs were approved during the first half of 2026, representing a 58.4% increase from the same period last year. After reaching 585 approvals in the first half of 2023, the figure declined to 324 in 2024 and 315 in 2025 before rebounding this year to its highest level in 3 years.The increase suggests pharmaceutical companies have recently stepped up efforts to expand their product portfolios. June alone accounted for 118 approvals, while 106 products were approved in April, marking the second month this year in which monthly approvals exceeded 100.By comparison, only July recorded more than 100 prescription drug approvals last year. Also, no month exceeded that level in 2024. In 2023, only January surpassed the 100-approval mark.Average monthly approvals reached 83 products during the first half, the highest level since the 93 recorded in 2022. Although the annual monthly average had declined from 93 in 2023 to 76 in 2024 and 48 in 2025, approvals have rebounded to an upward curve this year.Among the products approved in June, 48 orally disintegrating tablet (ODT) fixed-dose combinations of ezetimibe and rosuvastatin received marketing authorization. Companies obtaining approvals included Theragen Etex, Il-Yang Pharm, Ilhwa, Celltrion Pharm, KS Pharm, Dongkook Pharmaceutical, Mother’s Pharmaceutical, Jin Yang Pharmaceutical, HanAll Biopharma, Daehan Nupharm, Unimed Pharm, Withus Pharmaceutical, GC Biopharma, CMG Pharmaceuticals, Samjin Pharmaceutical, and GL Pharma.Competition also intensified in the market for potassium-competitive acid blockers (P-CABs) containing vonoprazan. Vonoprazan, the active ingredient of Takeda's product Vocinti that has not yet been launched in Korea, attracted significant interest, with Korean pharmaceutical companies obtaining 58 approvals for generic vonoprazan products during the first half alone. Companies preparing to enter the vonoprazan market include CMG Pharmaceutical, Unimed Pharmaceutical, Korea PMG Pharm, Medica Korea, DongKoo Bio & Pharma, Samjin Pharmaceutical, Eden Pharma, Celltrion Pharm, Alvogen Korea, BC World Pharmaceutical, KS Pharm, Yuhan Corporation, Dongkook Pharmaceutical, Genu Pharma, YooYoung Pharmaceutical, KyongDong Pharml, Vivozon Pharmaceutical, Hana Pharm, Korea Prime Pharm, GenuOne Sciences, Kolon Pharma, Korea Arlico Pharm, Ahn-Gook Pharm, Saehan Pharm, GC Biopharma, White Life Science, Samik Pharm, Mother’s Pharmaceutical, and Kyongbo Pharmaceutical.Industry observers believe another factor behind the increase is companies' efforts to secure as many reimbursements before the pricing reform takes effect in August.Under proposed revisions to the ‘Standards for the Determination and Adjustment of Drug Prices’ recently released by the Ministry of Health and Welfare (MOHW), the maximum reimbursement price for both off-patent originators and generic drugs will fall from 53.55% to 45% of the original branded drug price beginning in August, equivalent to a 16% reduction in generic reimbursement prices.Price reductions could become even steeper for products that fail to satisfy the requirements for receiving the highest reimbursement level, including conducting their own bioequivalence studies and using domestically registered active pharmaceutical ingredients (APIs).Under the revised system, the penalty for failing to satisfy the maximum-price requirements will increase from 15% to 20%. Since July 2020, generic manufacturers have been required to both conduct their own BE studies and use registered APIs to qualify for the maximum reimbursement price of 53.55%. Previously, the reimbursement ceiling fell by 15% for each unmet requirement, resulting in a total reduction of 27.75% if neither criterion was met. Under that system, reimbursement fell from 53.55% to 45.52% when one requirement was unmet and to 38.69% when neither requirement was satisfied.Under the revised framework, the new maximum reimbursement ratio of 45% will fall to 36% if one requirement is not met (20% cut) and to 28.8% if neither requirement is satisfied. Compared with the current system, these changes represent additional reimbursement reductions of 20.9% and 25.6%, respectively.From the industry's perspective, obtaining reimbursement before implementation of the new pricing rules allows products to receive relatively higher reimbursement prices, providing a strong incentive to accelerate approvals.Despite this year's rebound, prescription drug approvals remain well below historical levels. During the first half of 2019 and 2020, the MFDS approved 2,209 and 2,015 prescription drugs, respectively. The total fell to 1,073 in the first half of 2021 before declining further from 2022 onward. Compared with 2020, approvals in the first half of 2026 were 75.2% lower.Industry analysts attribute the sustained decline in generic market entry to changes in both the drug pricing and regulatory systems.Beginning in July 2020, Korea introduced a tiered reimbursement pricing system, under which reimbursement ceilings decline the longer the listing is delayed. Once 20 or more generic products are listed for a given ingredient, newly listed products are reimbursed at only 85% of the lowest existing reimbursement price. Because companies that do not independently develop generics or conduct their own bioequivalence studies receive substantially lower reimbursement, approvals for fully consigned generics have declined sharply.Regulatory barriers have also become more stringent. Since July 2021, amendments to the Pharmaceutical Affairs Act introduced the so-called "1+3 rule," limiting the number of generic and incrementally modified drugs that can rely on a single bioequivalence study.Under the regulation, if a generic is manufactured at the same facility using the same formulation and manufacturing process as the product for which the bioequivalence study was conducted, the bioequivalence data may be referenced by only three additional products. In other words, one bioequivalence study can support approval of only four generic products. Likewise, clinical data may be shared only with the original contract research organization’s product and up to three additional products.Previously, once one manufacturer obtained approval based on a bioequivalence study, dozens of other companies frequently obtained approvals for outsourced generics using the same data. The introduction of restrictions on joint development effectively ended the practice of unlimited generic replication.The surge in approvals during 2019 and 2020 was itself driven by anticipation of tighter government regulation. In 2018, sales of 175 valsartan-containing antihypertensive products were suspended after excessive levels of impurities were detected. In response, the MOHW and MFDS established a consultative body to develop measures aimed at curbing the excessive proliferation of generic drugs.As the government signaled stricter regulation, pharmaceutical companies rushed to secure generic approvals before the new rules took effect. Since implementation of the reforms, however, new market entry has slowed considerably.
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- Pfizer set to join RSV vaccine competition with Abrysvo
- by Eo, Yun-Ho Jul 07, 2026 08:57am
- Pfizer is set to officially enter the Korean respiratory syncytial virus (RSV) vaccine market.According to industry sources, the Ministry of Food and Drug Safety (MFDS) has entered the final stage of its review for ‘Abrysvo,’ Pfizer Korea's RSV vaccine. With its approval imminent, commercial launch is expected in the third quarter this year.Abrysvo’s initial indications are expected to include routine immunisation for infants, as well as indications for ▲ Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy, ▲ prevention of RSV-associated LRTD in adults aged 60 years and older.Abrysvo targets the fusion (F) protein, the major surface protein of RSV. It is specifically designed using the prefusion form of the F protein (pre-F), which the virus uses to enter host cells.The pre-F protein represents the structural form immediately before viral fusion with host cells and is recognized as the antigenic configuration that most effectively induces neutralizing antibodies. Abrysvo induces an immune response using a stabilized version of this prefusion protein.Abrysvo is a bivalent vaccine designed to provide protection against both major RSV subtypes, RSV-A and RSV-B. Its maternal immunization strategy relies on antibodies transferred across the placenta to protect infants during the first months of life.RSV is a prominent respiratory virus responsible for pneumonia and bronchiolitis. While it can infect people of all ages, the infection rate is particularly high among infants. It is known that approximately 90% of infants worldwide are infected with RSV before the age of two. In some cases, it can progress to serious lower respiratory tract diseases such as pneumonia or bronchiolitis, making RSV one of the leading causes of infant hospital admissions.Clinical evidence supporting Abrysvo comes from the Phase III MATISSE study. The trial demonstrated that vaccination in late pregnancy significantly reduced the risk of severe RSV-associated lower respiratory tract infection in infants in the first 6 months after birth through maternal antibody transfer.The anticipated approval and entry of Abrysvo is expected to further intensify competition in Korea's infant RSV prevention market, which is already occupied by Sanofi's ‘Beyfortus’ and MSD's ‘Enflonsia.’
