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- 2026-04-26 22:01:34
- Policy
- Spray formulation of 'nicotine' wins nod in KOR as OTC
- by Lee, Tak-Sun Sep 16, 2025 06:10am
- Product photo of Nicorette QuickMist sold overseasA spray formulation containing nicotine, which is used as a smoking cessation aid, received its first approval in Korea. The nicotine spray was previously discussed for classification as a prescription drug in 2019, but this time it obtained approval as an over-the-counter (OTC) drug that is exempt from safety and efficacy review. Spray formulations are widely used as OTC products overseas. On September 15, the Ministry of Food and Drug Safety (MFDS) approved Johnson & Johnson Korea's 'Nicorette QuickMist Mouthspray (nicotine).' This drug is an adjunct therapy for smoking cessation and is used to relieve nicotine cravings and withdrawal symptoms. As a nicotine replacement therapy (NRT), it reduces cravings and withdrawal symptoms by allowing nicotine to be absorbed through the oral mucosa. This drug is used in three stages: In Stage 1 (weeks 1-6), one spray is used when a craving to smoke arises. In Stage 2 (weeks 7-9), the daily usage is gradually reduced, with the goal of using half the average number of sprays used during Stage 1 by week 9. In Stage 3 (weeks 10-12), if the usage has been reduced to 2-4 times a day, the use of this drug should be discontinued. Complete smoking cessation is required while using the oral spray. The method of use is to open the mouth, bring the spray nozzle as close to the mouth as possible, and press firmly on the top of the spray to dispense it, avoiding the lips. J&J's Nicorette is a leading brand of smoking cessation aids sold in pharmacies. In Korea, three formulations are currently sold: Nicorette Gum, Nicorette Lozenges Coolmint, and Nicorette Invisi Patch. While the spray formulation is sold overseas, it had not been launched in Korea due to concerns over potential misuse and abuse. It has reportedly been sold as an OTC product in the UK for nearly 20 years. In 2019, the MFDS Central Pharmaceutical Affairs Advisory Committee (CPAC), while discussing approval for the nicotine spray formulation, had shared the opinion that classifying it as a prescription drug was appropriate. At that time, 5 out of 7 committee members favored a prescription drug classification due to concerns about misuse by adolescents. Subsequently, the nicotine spray formulation was not approved. Six years later, with MFDS granting approval for this drug as an OTC drug, which offers good consumer accessibility, it is gaining attention whether this market will become more active. The approval process also excluded a safety and efficacy review.
- Policy
- US pressures MFNs to cut drug prices
- by Lee, Jeong-Hwan Sep 16, 2025 06:09am
- As the US Trump administration pushes hard for Most Favored Nation (MFN) drug pricing policies, voices are growing within the industry that Korea should mitigate trade pressure by expanding the “risk-sharing agreement (RSA),” the key tool used during drug pricing negotiations in the reimbursement process. Industry representatives are arguing that non-innovative pharmaceutical companies’ new drugs developed for export, as well as anticancer and orphan drugs introduced through open innovation, should also be included in the refund-type RSA scheme. The industry insisted that the dual pricing system—currently applied only to exported drugs to allow higher external list prices—should also be extended to imported drugs. This would increase Korea’s freedom from U.S. pharmaceutical trade pressure while improving patient access. The Ministry of Health and Welfare acknowledged that Korea’s current drug price disclosure system is excessively transparent, creating disadvantages in international trade and exports, and promised to actively consider reforms such as refund-type RSAs and the dual pricing system. This signals a green light for system improvements in line with industry demands. On the 15th, Democratic Party of Korea lawmakers Yoon Kim and Youngseok Seo co-hosted a National Assembly debate on “Future Directions for the RSA System.” Professor Jeonghoon Ahn (Ewha Womans University, Department of Convergence Health Policy) who presented at the debate, explained that Korea’s drug prices significantly affect global markets. Initially, Korean drug prices were unofficially referenced by Asian countries. In 2013, Saudi Arabia formally included Korea as a reference country, followed by Canada in 2019, which greatly expanded Korea’s global pricing influence. Given that the US. MFN drug pricing policy under the Trump administration undermines the profitability of Korean drug exports, Prof. Ahn stressed that RSA expansion is necessary to address the issue. Ahn said, “Limiting RSAs only to anticancer and orphan drugs is far too restrictive compared to many advanced countries. If export-bound Korean drugs were also eligible for RSA, they could benefit when entering the US market. It is time to consider RSA expansion given the changing external environment.” “Refund-type RSA should also be applied to non-innovative pharmaceutical company’s anticancer drugs and rare disease drugs” Hee-Sung Kang, Head of the External Affairs Team at Daewoong Pharmaceutical, who participated as a panelist, expressed the opinion that expanding the scope of drugs eligible for the refund-type RSA would benefit domestic pharmaceutical companies pursuing export-focused strategies. When included as price reference countries in China, Southeast Asia, and BRICS nations, refund-type RSAs would allow higher list prices to be maintained while controlling domestic budget impact. This strategy would improve both domestic and global access to new medicines. “The March 2023 revision of the Drug Decision and Adjustment Criteria limited refund-type RSAs to innovative drugs developed by innovative pharmaceutical companies. But considering the reality of Korea’s pharmaceutical industry, new drugs from non-innovative pharmaceutical companies developed for export, as well as anticancer and orphan drugs introduced through open innovation, should also be eligible.” He added: “This would help maintain high list prices at the time of local reimbursement, reduce concerns about reference pricing by overseas developers, and ultimately expand treatment options for domestic patients. Even in cases of post-marketing price cuts, if companies can choose refund-type RSAs, companies can preserve list prices while securing market trust.” “Applying dual pricing system to imported drugs could resolve U.S. trade issues” In-Hwa Choi, Director of the Korean Research-based Pharmaceutical Industry Association (KRPIA), stated that the Trump administration's push for MFN drug pricing and the increased likelihood of high tariffs should not be viewed merely as external pressure. Instead, she urged using this as an opportunity to supplement and innovate the structural weaknesses of the domestic drug pricing system. Most importantly, Choi called for revising the refund-type RSA system, which distinguishes between list price and actual price. She noted that Korea’s drug price disclosure system is highly transparent, which is advantageous in some respects but creates structural disadvantages in international negotiations. As a solution, she proposed extending the dual pricing system—currently applied only to exported drugs—to imported drugs as well. “Korea introduced the dual pricing system in March to allow higher list prices for exported drugs to prevent the risk of unfavorable, low drug pricing abroad. If we extend this system to imported drugs as well, we can partially resolve supply stability risks that may arise under the MFN trade environment.” Choi also suggested rebranding the dual pricing scheme under a new name, such as “Korean-style refund system,” to avoid misunderstandings associated with the term. “Other countries also use alternative terms like MEA or claw-back system,” she said. She concluded: “The K-refund system could become a strategic innovation model that helps Korea manage trade uncertainties while improving both patient access and industrial competitiveness. Patients would benefit from timely and stable treatment; the government would gain fiscal efficiency; and the industry would strengthen global competitiveness—a true win-win solution.” MOHW “RSA, U.S. MFN, and other external changes in addition to industry demands necessitate improvements and development” Yeon-Sook Kim, Director of the Division of Pharmaceutical Benefits at MOHW, emphasized that the ministry's principle for national health insurance reimbursement of pharmaceuticals is ‘timely reimbursement of effective drugs’. Kim acknowledged that the RSA system is at a point where development is needed in response to changes in the external environment and the pharmaceutical industry's demands. She also agreed on the need to closely monitor and respond swiftly to the significant domestic impact of the Trump administration's trade pressure regarding most-favored-nation (MFN) drug pricing. Yeon-Sook Kim, Director of the Division of Pharmaceutical Benefits at MOHW She admitted that Korea’s single-payer national insurance system, with its fixed patient co-payment model, has limited flexibility. This, combined with high transparency in drug pricing, has sometimes caused “unintended disadvantages” for pharmaceutical companies. Regarding whether South Korea's new drug prices are truly low, Kim mentioned there is much debate among experts and responded with the intention to partially improve the transparent drug price disclosure system. Kim said, “Operating within a robust public health insurance system inevitably leads to a lack of flexibility. Consequently, while a highly transparent system has been established, we understand that pharmaceutical companies experience unintended harm and unfairness. AS a result, the current drug price disclosure system is transparent, but it must be improved to address the inherent risk of being unreasonably disadvantaged.” Kim added, “While there was much initial debate about RSA, it is now making a significant contribution to Korea’s national health insurance. However, it is time for it to evolve in response to changes in the external environment. Various terms like RSA or dual drug pricing systems are being discussed, and the government will actively and promptly review the drug pricing system.”
- Company
- Sanofi-MTPK sign exclusive sales agreement for Aubagio
- by Son, Hyung Min Sep 16, 2025 06:09am
- (From left), MI Youn Lee, Head of EP & Portfolio at Sanofi Korea and Australia/New Zealand; Won Kyu Lee, CEO of Mitsubishi Tanabe Pharma Korea) Mitsubishi Tanabe Pharma Korea (CEO Wonkyu Lee, MTPK) announced that it has entered into an exclusive domestic promotion and distribution agreement with the global biopharmaceutical company Sanofi Korea (General Manager Kyung Eun Bae), for the multiple sclerosis (MS) treatment Aubagio. The agreement officially took effect on September 1, 2025. Both companies aim to ensure stable product supply and patient-focused service through close collaboration. Through this partnership, MTPK has secured exclusive sales rights for Aubagio in Korea and will be responsible for local sales and marketing activities. Sanofi will continue to handle product importation, supply, regulatory affairs, and overall product management. Aubagio has demonstrated efficacy in reducing relapses and slowing disease progression in patients with relapsing multiple sclerosis. It is a once-daily oral therapy, offering convenience that is being used widely both in Korea and abroad. MI Youn Lee, Head of EP & Portfolio at Sanofi Korea and Australia/New Zealand, stated, “With this agreement, we expect that more Korean MS patients will gain stable access to the therapeutic benefits of Aubagio. Sanofi will continue to strive to build a sustainable treatment environment that allows patients to maintain better treatment and improve their quality of life.” Won Kyu Lee, CEO of MTBK also said, “Drawing on our extensive experience in the field of neurological diseases, we will do our utmost to ensure Aubagio reaches Korean MS patients more effectively. In line with our corporate philosophy, we will continue to enhance corporate value through the introduction of innovative new drugs and contribute to patients and society through ongoing activities.”
- Policy
- "Gov't actively supports the development of new drugs"
- by Lee, Jeong-Hwan Sep 16, 2025 06:08am
- Ministry of Health and Welfare (MOHW) The Ministry of Health and Welfare (MOHW) explained that its establishment of a first-ever 'Phase 3 Specialized Fund' as one of its budget projects for next year is the result of government's commitment to creating innovative new drugs in Korea. The MOHW also announced that it would first design a specific business model for the 'Loan System for New Drugs Based on Success' by next year through a research project, and then begin selecting pharmaceutical and bio companies to receive benefits from 2027. A MOHW official, in a recent meeting with the Korea Special Press Association, explained, "The establishment of a specialized fund by the government to support pharmaceutical companies with the will and capability to develop new drugs in Phase 3 is the first of its kind, and it holds significant meaning." The MOHW has allocated KRW 60 billion in new costs for the establishment of the Phase 3 specialized fund next year. The goal is to establish a total fund of KRW 150 billion by combining the MOHW's contribution and investment from a fund of funds. This fund will then be used to select and support pharmaceutical and bio companies that have innovative new drug and Bio-Better pipelines and the intention to pursue Phase 3 clinical trials. Once the fund is established, the MOHW will not be directly involved in the selection of pharmaceutical companies or new drug candidates, entrusting that responsibility to investment firms. The MOHW also allocated KRW 500 million for a research service budget to design a Korea model for the 'Loan System for New Drugs Based on Success.' Given that it is rare to invest such a large amount, such as millions of KRW, into a research budget, it demonstrates a strong will to design a proper loan model for Korea. The Loan System is a policy that exempts or partially reduces the loan repayment responsibility for pharmaceutical companies that receive government investment and support for new drug development, even if the new drug ultimately fails to be created. If next year's budget is approved by the National Assembly, the MOHW plans to do its utmost to ensure that domestically developed new drug and bio companies can receive tangible benefits. A MOHW official said, "The Phase 3 specialized fund requires consultation with policy banks and other institutions. It's difficult to proceed with just government contributions, so we need to raise external investment." He stressed that, "While a KRW 150 billion fund may not be large when you consider the costs required for Phase 3, the fact that this is the first time the government is establishing a specialized fund to provide customized support for Phase 3 clinical trials is what makes it meaningful." The official added, "This is a demonstration of the government's strong will to discover new drugs." He continued, "The fact that this is the first time we are providing such support is impressive, and if the project is successful, we can increase its size, which makes it a crucial budget." And added, "For the Loan System, we will only be conducting research next year. We've allocated KRW 500 million, which is a significant amount for a research budget." He added, "We will design a specific implementation plan and a practical loan model for new drugs. After completing the research next year, we plan to reflect the actual project support budget in the 2027 budget plan." Finally, He said, "The Loan System requires collecting many opinions from the pharmaceutical and biotech industry during the research process," and added, "We need to discuss details, including pharmaceutical companies willing to support, the number of new drugs, and the criteria for success. We decided that we need such a system to encourage challenging investments in new drug development, which has a high probability of failure, and the Ministry of Economy and Finance agreed to include it in the budget plan."
- Company
- Active treatment needed for childhood·adolescent obesity
- by Eo, Yun-Ho Sep 15, 2025 06:03am
- With interest in obesity management becoming higher than ever with the introduction of Mounjaro and Wegovy, attention is also gathering to neglected areas. In particular, the rising prevalence of childhood obesity and the limited treatment options have raised the need for improved treatment environments. Globally, obesity has become the most common nutritional disorder among children, leading to physical problems such as growth hormone deficiency, precocious puberty, and polycystic ovary syndrome, as well as psychosocial issues including low self-esteem, depression, and anxiety. Since children and adolescents are continuously growing in height and weight, obesity is diagnosed using body mass index (BMI) percentiles based on sex and age. According to the Korean Society for the Study of Obesity’s Clinical Practice Guidelines (2022, 8th edition), children aged two years and older should be assessed using the 2017 growth chart: BMI at or above the 85th percentile is considered overweight, and at or above the 95th percentile is considered obese. ◆Childhood and adolescent obesity is on a continuous rise...Korea is also at risk The problem is the sharp increase in the childhood and adolescent obesity population. According to a pooled analysis by the World Health Organization (WHO) and Imperial College London, the number of obese children and adolescents has increased by more than tenfold over the past 40 years. By analyzing BMI and obesity prevalence trends from height and weight measurements in populations aged 5 and older across 200 countries between 1975 and 2016, the prevalence of childhood obesity rose from less than 1% in 1975 to 6% among girls and 8% among boys in 2016. This indicates a steady global rise in both the number and proportion of children affected by obesity, with particularly sharp increases in regions such as the Middle East and North Africa, South Asia, East Asia, and high-income English-speaking countries. Prevalence of Pediatric and Adolescent Obesity in Korea In line with global trends, obesity prevalence among Korean children and adolescents has also been on the rise. According to the “2021 National Health Statistics” published by the Korea Disease Control and Prevention Agency, obesity prevalence among boys aged 6–18 increased to 19.5% in the 8th survey period from 11.1% in the 5th (a 1.76-fold increase), while among girls it rose to 12.7% from 9.2%, which is a 1.38-fold increase. Also, a sample survey of elementary, middle, and high school students released by the Ministry of Education in April showed that 29.3% of students fell into the overweight or obese category last year—which is roughly one in three. ◆Academic community aligns with clinical guidelines...recommends drug therapy Given this situation, clinical guidelines for childhood and adolescent obesity are also evolving. Notably, the necessity for more direct treatment approaches, including previously conservative drug therapy, is increasingly being raised. According to the guidelines released on January 9, 2023, by the American Academy of Pediatrics (AAP) for the evaluation and treatment of childhood obesity, pharmacological therapy is recommended for children aged two and older, and surgical interventions are permitted from age 13 onward—emphasizing active intervention from the early stages of diagnosis. The recommended medications include Saxenda (liraglutide), Wegovy (semaglutide), Xenical (orlistat), and Qsymia (phentermine/topiramate). This has sparked debate by overturning the tendency to prioritize traditional dietary and behavioral therapies in children and adolescents, but it also underscores the urgent need for obesity management in severely obese children and adolescents. Korea has also recognized the need for pharmacotherapy. In 2022, the Korean Society for the Study of Obesity recommended considering drug therapy under the supervision of experienced specialists if intensive diet, exercise, and behavioral therapy fail to control ongoing weight gain and obesity-related comorbidities in children Furthermore, the first guidelines on childhood obesity that was published in Asia, which was in 2019, covered the ▲definition and diagnosis of overweight and obesity in children, ▲treatment principles of pediatric obesity, ▲behavioral therapy (including diet, exercise, lifestyle, and mental health), ▲pharmacological treatment, and ▲surgical treatment. For each area, they established recommendations and their respective levels of evidence (Level A–D). Professor Hye-Woon Jung of Kyung Hee University Hospital’s Department of Pediatrics said, “Lifestyle intervention is important for severely obese children and adolescents, but it may not be enough. In such cases, active pharmacological treatment should be considered. Although some medications are approved for severe pediatric obesity, treatment options remain limited in Korea.”
- Policy
- Jardaince patent expires Oct 23…over 400 generics expected
- by Lee, Tak-Sun Sep 15, 2025 06:02am
- Product photo of Jardiance As the substance patent for Jardiance (empagliflozin, Boehringer), an SGLT2 inhibitor for the treatment of diabetes, is expiring next month (October 23), over 400 generic drugs are expected to be introduced to the market. Notably, domestic pharmaceutical companies in Korea have developed empagliflozin + metformin extended-release tablets and are launching the first type of combination therapies, such as empagliflozin + sitagliptin. They are expected to revitalize the sales market. According to industry sources on September 14, Korean pharmaceutical companies announced the launch of Jardiance generic drugs next month and began pre-marketing. Along with Forxiga, which was withdrawn from the Korean market, Jardiance is among the top two SGLT inhibitors for the treatment of diabetes. Based on last year's UBSIT, outpatient prescription sales for Jardiance monotherapy amounted to KRW 66.3 billion and for Jardiance Duo (empagliflozin + metformin) recorded KRW 41.8 billion, accounting for a market exceeding KRW 100 billion. Esgliteo, a combination of empagliflozin and linagliptin, also recorded KRW 12.1 billion and became a blockbuster drug. Domestic pharmaceutical companies that seized the opportunity for the Forxiga patent expiration in April 2023 are also entering the Jardiance market, which is a KRW 100 billion market, with their generic drugs. A total of 412 empagliflozin monotherapy and combination products have been approved so far. Pharmaceutical companies like Hanmi Pharmaceutical and Daewon Pharmaceutical are expected to receive higher prices by entering the generic drug market with their independently developed data-submission drugs. Several generic products were developed before the implementation of the joint bioequivalence test regulation, which meant they could not meet the self-developed bioequivalence test conditions. Among the generic monotherapies, only Dongkoo Bio & Pharma and Huons have met the requirements. Consequently, Dongkoo Bio & Pharma, which contract-manufactures generic drugs for over 20 pharmaceutical companies, is expected to receive the highest price among generics due to the innovative pharmaceutical company premium. With this premium, a cost of KRW 396 for the 10mg dose and KRW 518 for the 25mg dose is set, which corresponds to a 68% markup of the highest-priced drug. Among the generic drugs for the empagliflozin + metformin combination, there is also an extended-release film-coated tablet formulation that is taken once daily. The original product does not have an extended-release formulation. Additionally, Chong Kun Dang and Daewon Pharmaceutical have developed combination therapies that combine empagliflozin with the DPP-4 inhibitor sitagliptin, which they will be the first to introduce to the Korean market. An unprecedented level of competition is expected due to the entry of these generic drugs, which circumvented the joint bioequivalence test regulation. In addition, there are also drugs from pharmaceutical companies like Hanmi Pharmaceutical and Daewon Pharmaceutical, which have developed their products using in-house technology and new extended-release formulations. Related to this, a fierce competition is anticipated to create new prescriptions, with pharmaceutical companies pursuing independent sales and numerous CSOs joining in, offering high commission rates. In response, Boehringer Ingelheim, which holds the original Jardiance that recently succeeded in obtaining expanded reimbursement to cover chronic kidney disease, is expected to defend its existing accounts while also actively expanding into new ones for a year, during which it will be granted a 70% premium on the highest price. Jardiance is co-promoted in Korea with Yuhan Corporation.
- Company
- NIP inclusion of Beyfortus sparks discussion
- by Hwang, byoung woo Sep 15, 2025 06:02am
- The results of a study on the cost-effectiveness of Sanofi’s RSV preventive antibody injection for infants, Beyfortus (nirsevimab), have been published, sparking debate around including Beyfortus in Korea’s National Immunization Program (NIP). Pic of BeyfortusA research team led by Professor Hae-Sun Suh from Kyung Hee University College of Pharmacy recently published Beyfortus’s cost-effectiveness when introducing it to Korea. This study is the first in Korea to analyze the cost-effectiveness of Beyfortus and was published in the international journal ‘Human Vaccines & Immunotherapeutics’. The study compared two strategies: administering Beyfortus to all infants under 12 months and to high-risk children under 24 months, versus the current strategy of administering a preventive antibody injection (palivizumab) only to high-risk infants. Using claims data from the Health Insurance Review and Assessment Service (HIRA), the team conducted a cost-utility analysis (CUA) from a societal perspective. This included outpatient and inpatient treatment, management of complications, caregiver productivity loss, and socioeconomic costs from premature death. Results showed that using the Beyfortus strategy on all infants under 1 year of age and high-risk groups under 2 years of age reduces unnecessary medical costs associated with RSV infection and alleviates the burden of productivity loss for caregivers. In particular, it was confirmed that over 90% of the overall health improvement effect originated from the group of full-term infants under one year of age, supporting the validity of a universal RSV prevention strategy for all infants. Furthermore, the incremental cost-effectiveness ratio (ICER) for introducing the Beyfortus prevention strategy compared to the existing strategy was USD 33,071 per QALY (approximately KRW 43 million per QALY), demonstrating its cost-effectiveness. QALY, the cost-effectiveness indicator used in this study, is a health outcome measure that reflects health-related quality of life by applying a weight. It quantifies ‘how long and how healthily one can live’ through treatment and prevention. Although a cost-effectiveness threshold is not explicitly defined in Korea, analysis using commonly accepted standards—ranging from approximately USD 35,000 (per capita GDP) to USD 50,000 (1.5 times per capita GDP)—showed this study demonstrated cost-effectiveness within that range. Professor Suh said, “This study confirmed that a prevention strategy utilizing Beyfortus is not only effective for preventing RSV in infants and young children in Korea, but also provides a valid basis for its inclusion in a nationwide universal vaccination program. We hope these results will serve as key policy data for the future introduction of Beyfortus into the National Immunization Program, thereby contributing to protecting infant and young child health and reducing the social burden.” Beyfortus demonstrates cost-effectiveness …Will it synergize with the revised legislation? The published research on Beyfortus is expected to bolster future discussions regarding the National Immunization Program (NIP). Given the NIP's inherent goal of maximizing the vaccination effect through universal immunization, cost-effectiveness remains a critical consideration alongside efficacy. This aspect is included in the ‘Bill for the Partial Amendment to the Infectious Disease Prevention and Management Act’ proposed by Representative Yong-ki Jeon of the Democratic Party of Korea last August, which addresses RSV's inclusion in the NIP. While the legislative intent stated that it aims to contribute to public health improvement through infectious disease prevention by mandating essential vaccinations for acute respiratory infections, the inclusion of provisions regarding the submission of cost estimation requests implies that future submission of vaccine cost-effectiveness evaluation data is a prerequisite. Particularly, it is analyzed that the fact that the Korea Disease Control and Prevention Agency (KDCA) has not established clear guidelines for the preventive antibody Beyfortus within the NIP program, which has primarily focused on vaccines, could positively influence its potential inclusion in the universal vaccination program. Hee-kyung Park, Head of Sanofi’s Vaccine Division, said, “While 90% of infants under 2 years old are infected with RSV, there are no available treatments for RSV, making prevention crucial. Hospitalizations due to infant RSV infection place a significant burden on parents and families raising children. Therefore, establishing an effective prevention strategy accessible to all infants is paramount.” Park added, “Sanofi will continue to protect infant health and reduce the medical and economic burdens faced by families and society through innovative preventive solutions.”
- Policy
- Reimbursement review is underway for 'Ozempic'
- by Lee, Tak-Sun Sep 15, 2025 06:02am
- Ozempic 'Ozempic (semaglutide, Novo Nordisk),' a diabetes treatment with the same active ingredient as the injectable Wegovy, has been reapplied for National Health Insurance reimbursement. Novo Nordisk submitted a reimbursement application for Ozempic to the Health Insurance Review & Assessment Service (HIRA) in the first half of this year, and the review is reportedly now underway. Ozempic is garnering attention regarding whether it will be successfully added to the reimbursement list this time, as its previous attempt in 2023 was halted just before it could be listed. According to industry sources on September 11, Novo Nordisk recently submitted supplementary documents related to Ozempic's reimbursement to HIRA. A review of Ozempic's reimbursement appropriateness is reportedly underway, and it is expected to be considered by the Drug Reimbursement Evaluation Committee (DREC) within the year. Ozempic had already passed the DREC in February 2023. At that time, the DREC recognized the appropriateness of sOzempic's reimbursement on the condition that the company accept a price below the evaluated amount, which the company agreed to. The Korean Diabetes Association and the Korean Endocrine Society had submitted their opinion to the PBEC, stating that it was appropriate for Ozempic, a long-acting GLP-1 receptor agonist, to have a reimbursement scope similar to that of Trulicity, which is in the same class and has also been the subject of a comparative clinical study. Subsequently, it entered drug price negotiation with the National Health Insurance Service (NHIS), but the reimbursement application was withdrawn due to the company's internal circumstances. Industry sources report that the company halted the reimbursement process at the time because the explosive demand for semaglutide products, such as Wegovy, in the global market made it difficult to supply the drug in Korea. The company's decision to re-pursue reimbursement this time is analyzed as being influenced by the full-scale entry of Mounjaro (tirzepatide, Lilly), Wegovy's competitor, into the Korean market. Mounjaro received domestic approval as an obesity treatment last September, and a reimbursement application for its diabetes indication was submitted in July. The Korean academic community also views the reimbursement of Ozempic and Mounjaro positively. This year's '2025 Diabetes Clinical Practice Guidelines' present both drugs as having a significant blood sugar-lowering effect. Currently, the only reimbursed product among drugs that bind to GLP-1 (Glucagon-like Peptide-1) receptors to lower blood sugar, like these two drugs, is Lilly's Trulicity (dulaglutide).
- Opinion
- [Reporter’s View] Real test begins for K-CDMOs
- by Son, Hyung Min Sep 15, 2025 06:01am
- In the midst of global supply chain restructuring, Korea’s CMO (Contract Manufacturing Organization) and CDMO (Contract Development and Manufacturing Organization) industries are emerging as new growth drivers for the biopharmaceutical sector. The shift away from China is acting as an opportunity factor, while independent achievements based on Korean firms’ technology and quality are also increasing. However, challenges such as potential overcompetition and global political and security risks still loom large. Samsung Biologics has been securing large-scale contracts since the beginning of this year. The company signed agreements worth more than USD 1 billion each with pharmaceutical firms in the U.S. and Europe. Its cumulative orders for the year have reached KRW 5.2435 trillion, nearly matching last year’s total of KRW 5.4035 trillion in just 8 months. Since its founding, the company’s cumulative orders have exceeded USD 20 billion. ST Pharm, though smaller in size, is also attracting attention with solid contracts. It secured a KRW 20.3 billion deal with a European pharmaceutical company for small-molecule APIs, and a KRW 18.3 billion supply contract with a U.S. biotech firm for oligonucleotide APIs. Its order backlog surged 76% from KRW 232 billion at the end of last year to KRW 407.9 billion as of date. Once considered a latecomer in RNA therapeutics manufacturing, ST Pharm has quickly increased its presence by signing consecutive deals with global companies. SK Pharmteco achieved a symbolic milestone in December last year with a KRW 2 trillion order for obesity drug APIs. At a time when global pharmaceutical firms are heavily investing in the development of GLP-1 class drugs, the fact that a Korean CDMO has actively joined this trend carries significance. At the same time, the company has also demonstrated diversification potential in cell and gene therapy (CGT), securing a contract with Switzerland’s Ferring Pharmaceuticals for a bladder cancer therapy. Smaller and mid-sized firms are also moving actively. ENcell signed a KRW 5.7 billion AAV gene therapy CDMO contract with the Korea Research Institute of Bioscience and Biotechnology in July, the largest single deal in the company’s history and equivalent to 80% of its annual revenue. Prestige Biologics landed a KRW 13.2 billion deal with an undisclosed pharma company, laying the groundwork for long-term CDMO operations. Medipost also entered the CDMO market in earnest with a KRW 2 billion deal for cell therapy manufacturing. However, viewing this trend solely as a ‘tailwind’ may raise issues. While it's true that global pharmaceutical companies are turning their attention to Korea, it also means the competitive arena has broadened and become more complex. Potential manufacturing bases like India and Eastern Europe are also rapidly expanding their scale. This is precisely why Korean CDMOs must differentiate themselves by emphasizing development capabilities and innovative technologies, moving beyond simple contract manufacturing. Moreover, the moment dependency increases, paradoxically, so does the risk. If revenue becomes concentrated on specific companies or products, the structure becomes entrenched, making it more vulnerable to external environmental changes. To avoid a ‘second China dependence’ incident, the contract portfolio needs to be diversified, and a mid-to-long-term investment roadmap supported. The surge in orders driven by the de-China effect is also sparking concerns of excessive competition among Korean companies. While the U.S. Biosecure Act may restrict Chinese firms, companies from Japan and Eastern Europe are also moving to capture opportunities in supply chain realignment. This makes it difficult to assume that Korea alone will enjoy a sustained boom. The recent contract wins are certainly encouraging signals. Yet, as the saying goes, true competitiveness lies not in winning contracts but in maintaining them. What is needed now is not celebration, but sober assessment.’ The boom Korean CDMOs are experiencing is only the beginning. The answer to whether they can lead the global market through ‘development’ and ‘innovation’ beyond mere ‘contract manufacturing’ will naturally emerge through the challenges ahead.
- Company
- MSD vs Medihelpline PMS contract dispute goes on trial
- by Eo, Yun-Ho Sep 12, 2025 06:19am
- A legal battle is looming between multinational pharmaceutical company MSD Korea and CRO firm Medihelpline over payment disputes related to a PMS outsourcing contract. According to Dailypharm coverage, MSD recently filed a lawsuit against Medihelpline, demanding the return of part of the advance payments made under a PMS outsourcing contract. However, the complaint was returned due to the recipient’s absence. Prior to this, Medihelpline had filed a “subcontract dispute mediation request” with the Subcontract Dispute Mediation Council of the Korea Trade Mediation Agency, claiming that MSD failed to pay approximately KRW 1.5 billion in subcontract fees. In other words, both sides are insisting that the other is responsible for the unsettled payments under the same outsourcing contract. PMS (Post-Market Surveillance) refers to the system of collecting data from 600 to 3,000 patients over four to six years after a new drug is launched, to report the usage results to the Ministry of Food and Drug Safety (MFDS). Medihelpline’s role under the contract was to visit medical institutions prescribing MSD’s drugs, collect PMS data, and prepare submission documents for the MFDS, in return for payment. Such outsourcing contracts are extremely common and are conducted countlessly in the pharmaceutical industry. The dispute can be summarized as follows: Between 2017 and 2022, the two companies entered into outsourcing contracts to conduct PMS for seven of MSD’s products, known collectively as the “MK Family.” Out of these, PMS services for 3 products were carried out smoothly. The problem arose with the remaining 4 products, where execution was insufficient. Among them were products that MSD had abandoned, and at the time, Medihelpline was also struggling with mass staff layoffs, making normal operations difficult. The conflict surfaced during the settlement process for this contract. According to the settlement data Medihelpline submitted in the first half of 2025, the work the company did for the 3 products exceeded the estimated amounts based on actual cases, meaning MSD owed an additional KRW 530 million. MSD accepted and agreed to this. The ‘estimated amount’ refers to the figure set at the time of the initial contract, since the exact number of actual cases cannot be predicted in advance due to the nature of PMS contracts. In other words, PMS projects inherently involve significant variability. However, for the four products where execution was lacking, the services naturally fell well short of the estimated amounts. MSD expressed its intent to settle payments based on the actual number of cases performed. Medihelpline rejected this, insisting that settlement should be based on the estimated figures stated in the original contract. Issue 1: Estimated amounts in the contract vs. the unique nature of PMS agreements The dispute centers on two key points: whether payments should be made for actual work performed or strictly according to the contract's estimated figures, and to what extent the contract allows for flexibility in dealing with the inherent variability of PMS projects. Medihelpline argued that this dispute represents “abuse of power over a subcontractor in a hierarchical relationship,” and stated, “If MSD simply pays according to the original contract, there would be no issue. We will fight this to the end.” Thus, the key issue becomes whether it is valid for a PMS outsourcing contract between a pharmaceutical company and a CRO to be settled based on the estimated figures written in the contract. MSD’s stance is “No.” According to the company, the core of PMS is tracking the outcomes of individual patients’ treatments, and outsourcing contracts are by definition based on the number of cases. The estimated figures in the contract are merely references to approximate the expected scale at the outset, written with the understanding that settlement would be based on actual cases. In fact, Medihelpline demanded an additional KRW 530 million beyond the estimated amounts specified in the contract for 3 successfully completed products, citing extra costs incurred from conducting sub-analyses of the collected data. Medihelpline also informed MSD in November 2023 that the advance payments it had already received exceeded the actual work performed by KRW 800 million KRWand requested suspension of further advance payments as well as offsetting against payments for other projects. Medihelpline sought extra payment for over-fulfilled work and requested suspension where less was done, implicitly acknowledging the contract's case-based nature. An MSD representative stated, “This is not the first time we’ve worked with Medihelpline on PMS outsourcing. In all past contracts, settlement has always been based on actual cases performed. The advance payments for the 4 projects clearly exceed the services delivered. We filed the refund claim lawsuit not merely to recover the advance, but to put an end to the CRO’s accusations and this settlement dispute through civil litigation.” In response, a Medihelpline representative responded, “The email sent to MSD in 2023 was sent unilaterally by an individual without management’s approval, at a time when the company was experiencing major internal changes, including mass resignations. There is a signed contract, and it is proper to honor it as written. MSD is exploiting a single mistake as a weakness.” Issue 2. Whether PMS contracts fall under the scope of the Subcontracting Act Another key issue is the Subcontracting Act. Medihelpline claims that MSD Korea’s failure to pay violates Articles 11 and 13 of the Subcontracting Act, and has filed a dispute mediation request with the Fair Trade Commission. The alleged violations are Article 11(2) of the Act, which states that “a principal contractor shall not reduce subcontract payments once agreed upon,” and Article 13, which requires that “when the principal entrusts manufacturing, the subcontract payment must be made within 60 days of receiving the deliverables, or within the shortest period possible.” The Subcontracting Act was established to correct unfair trade practices between large corporations and small or medium-sized enterprises, and to protect subcontractors as the economically weaker party. If Medihelpline’s claims are true and a global corporation like MSD abused its position to exploit a small domestic CRO, then such conduct deserves to be sanctioned. Thus, the issue lies in whether settlement based on actual cases performed in PMS contracts constitutes abuse of power, and whether such contracts fall within the scope of subcontracting arrangements. The law lists specific industries—such as engineering, transportation, construction, and security—as falling under subcontracting, while leaving other activities to be designated by the Fair Trade Commission. Therefore, the customary practices of PMS contracts between multinational pharmaceutical companies and domestic CROs, as well as precedents and the legitimacy of such arrangements, are likely to become key criteria in the court’s judgment. A Medihelpline representative stressed, “The company is facing severe financial difficulties due to MSD’s non-payment along with other factors, and we will confront MSD’s actions head-on beyond the mediation request. We are confident this is a clear violation of the Subcontracting Act.” An MSD representative lamented, “For over a year, we have made continuous efforts to pay costs in accordance with the proper contractual procedures. Nevertheless, Medihelpline has refused to cooperate in settling the service fees, instead making groundless accusations that damage our reputation and credibility. We regret this deeply.”
