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- 2025-12-18 16:34:06
- Policy
- Bill bans remote narcotics and hair loss drug prescriptions
- by Lee, Jeong-Hwan Sep 17, 2025 06:10am
- A partial amendment to the Medical Service Act was introduced in the National Assembly on the 16th, mandating that physicians check the Drug Utilization Review (DUR) system when prescribing via telemedicine. The rule applies to high-risk drugs such as narcotics, psychotropics, anti-obesity drugs like Wegovy, hair loss treatments, and isotretinoin acne drugs that are prone to misuse. The bill stipulates that physicians must confirm the DUR system when prescribing any drugs designated by the Ministry of Health and Welfare as prohibited for telemedicine. Violations will result in administrative fines of up to KRW 3 million. Rep. Sunmin Kim (Rebuilding Korea Party), who proposed the bill as representative, explained, “In telemedicine, physicians cannot prescribe government-banned drugs once they check DUR at the time of prescription. This legislation codifies the existing safeguard into law.” If enacted, the bill is expected to close loopholes where telemedicine could otherwise be exploited as a channel for prescribing high-risk, non-reimbursed drugs. The bill amends Article 18-2 (“Confirmation of Drug Information”) of the Medical Service Act, adding a clause requiring physicians and dentists providing telemedicine to check DUR before issuing prescriptions or dispensing medicines themselves. Terminology adjustments include renaming “telemedicine” (Article 34) to “non-face-to-face cooperative care,” while defining “telemedicine” in a new Article 34-2. The definition covers patient monitoring, consultation, education, diagnosis, and prescribing using computers, laptop computers, video conferencing, outside of medical institutions. Also, the bill limited telemedicine subjects to returning patients, residents in medically underserved regions (islands, remote areas), inmates in correctional facilities and military personnel, and patients eligible for proxy prescription pickup. Effectively, first-time patients cannot use telemedicine unless under special circumstances, being restricted access to telemedicine. Specifically, for patients eligible for limited initial telemedicine, the Minister of Health and Welfare can now legally prescribe the types of medications that cannot be prescribed and set appropriate prescription durations, thereby establishing legal safeguards to prevent adverse effects from initial remote consultations. Also. the MOHW minister may designate specific disease groups requiring non-face-to-face telemedicine consultations via video communication for clear diagnosis. Patients with burns are expected to fall under this category. The bill also newly establishes provisions for telemedicine platforms, specifying the authority and responsibilities of the platform industry within the Medical Service Act. To provide or operate a non-face-to-face medical care intermediary platform, one must report to the Minister of Health and Welfare according to standards set by the Minister of Health and Welfare. Compliance requirements for telemedicine platforms are also newly established as separate provisions, and platform management and supervision standards are included in the law. The bill prohibits platforms from interfering with a physician's medical judgment, encouraging the misuse or abuse of medical services or pharmaceuticals, or engaging in acts that undermine healthcare order or harm patient health. Specifically, telemedicine platforms shall not arrange, induce, or instigate collusive acts as defined by the Pharmaceutical Affairs Act. Platforms must not, either directly or through third parties, introduce, arrange, or lure patients or individuals holding prescriptions to specific medical institutions, medical practitioners, pharmacies, or pharmacy owners/employees, and in return, provide, demand, or promise money, goods, benefits, labor, entertainment, or other economic advantages, nor receive such from medical institutions or similar entities. Platforms are also prohibited from inducing users to recommend or select specific medical institutions or pharmacies. Platforms are required to report quarterly to the Minister of Health and Welfare on the number of users of telemedicine platforms and the medical specialties involved, for the purpose of surveying the status of such telemedicine intermediaries. The Minister of Health and Welfare may order platforms to provide necessary data for this purpose. Additionally, platforms must submit quarterly reports to the MoHW on telemedicine use, including number of users and medical departments involved. The Minister may also request further data as needed. If platforms violate service standards or fail to comply with corrective orders, the Minister may restrict or suspend facility or equipment use. Non-compliance with such orders can result in license cancellation or suspension of business operations for up to one year. These provisions establish legal grounds for cancellation of platform registrations and suspension of operations in cases of regulatory breaches.
- Company
- "PSA test determines prostate cancer survival rate"
- by Son, Hyung Min Sep 17, 2025 06:09am
- There is a growing need to introduce prostate-specific antigen (PSA) test for the early diagnosis of prostate cancer. On September 16, the Korean Urological Oncology Society held a press conference at the Press Center, highlighting current updates on prostate cancer and emphasizing the importance of early diagnosis through PSA testing. Professor Byong Chang Jeong, President of the Korean Urological Oncology Society (Samsung Medical CenterAccording to the National Cancer Registration Program's announcement last year, there were 20,754 new prostate cancer patients in 2022, accounting for 7.4% of all cancer cases. In particular, the incidence of prostate cancer in individuals aged 65 and over reached 416.1 per 100,000 people, and this burden is expected to grow as Korea approaches a super-aged society. Professor Byong Chang Jeong, President of the Korean Urological Oncology Society (Samsung Medical Center's Department of Urology), said, "The Society has designated the third week of September as 'Prostate Cancer Awareness Week' and has been conducting various campaigns to spread correct awareness of prostate cancer and establish early screening as a part of daily life." Professor Jeong stressed, "We are raising awareness about the importance of early diagnosis, such as with PSA testing." A variety of treatments for prostate cancer have been introduced, leading to improvements in patient survival rates. Androgen receptor inhibitors, such as Janssen's Zytiga, Erleada, and Akeega, Astellas' Xtandi, and Bayer's Nubeqa, are being used. Recently, radiopharmaceuticals have also emerged. Novartis' Pluvicto received domestic approval in Korea last May and is now available for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have previously received an androgen receptor pathway inhibitor and a taxane-based chemotherapy. PSMA is a proteolytic enzyme synthesized in the epithelial cells of the prostate. Its expression is typically high in high-grade, metastatic, and castration-resistant prostate cancer. Compounds that combine a ligand binding to PSMA with a radioisotope that emits relatively low energy (Gallium-68) are used for PET/CT diagnosis. In contrast, compounds combined with a high-energy emitting radioisotope (Lutetium-177) can be used as a treatment. Additionally, several Korean biopharmaceutical companies, including FutureChem and Celltrion, are also developing radiopharmaceuticals for prostate cancer. Professor Park Sung-woo, Vice President of the Korean Urological Oncology Society (Pusan National University Yangsan HospitalProfessor Park Sung-woo, Vice President of the Korean Urological Oncology Society (Pusan National University Yangsan Hospital's Department of Urology), assessed, "When prostate cancer is detected early, the treatment outcomes are so good that it is often curable. However, if it metastasizes, the treatment outcomes rapidly worsen." He stated, "Early diagnosis is a key variable that determines a patient's survival rate and quality of life." Park added, "Various treatments have been included in the reimbursement list, contributing to improved survival rates. However, the speed of listing is slow compared to the pace of new drug launches. If new drugs that emerge in the future are quickly covered by reimbursement, it will help improve the survival rates of prostate cancer patients." PSA testing plays critical role in the early diagnosis of prostate cancer Prostate cancer, like other cancer types, often has few early symptoms, making it difficult for patients to be aware of the disease and leading to delayed diagnoses. Because of this, PSA testing plays a critical role in the early diagnosis of prostate cancer. PSA is a protein produced by the prostate, and its levels increase when cancer cells multiply. The PSA test, a simple blood test, has a low patient burden and high accessibility. If included in regular health check-ups, it could significantly enhance the effectiveness of prostate cancer management. Professor Young Hwii Ko, Editor-in-Chief of the Korean Urological Oncology Society (Ewha Womans University Medical CenterBased on PSA levels, Gleason score, and stage, prostate cancer is classified into risk groups: ▲low-risk (PSA ≤10, Gleason score ≤6, stage T1-T2a) ▲intermediate-risk (PSA >10 to ≤20, Gleason score 7, stage T2b) ▲high-risk (PSA >20, Gleason score 8-10, stage T2c or higher). Since the treatment strategy varies depending on the stage, PSA testing has the advantage of quickly identifying which risk group a patient belongs to, going beyond just early diagnosis. Professor Young Hwii Ko, Editor-in-Chief of the Korean Urological Oncology Society (Ewha Womans University Medical Center's Department of Urology), said, "The treatment outcomes and survival rates for prostate cancer are dramatically different depending on whether it's diagnosed early." He added, "The PSA test is both simple and highly accurate. If the PSA test were included in the NIP, it could help increase patient survival rates and reduce socioeconomic costs."
- Company
- Will the new GVHD drug Rezurock be reimbursed in 2H?
- by Eo, Yun-Ho Sep 16, 2025 06:10am
- Attention is growing over whether the graft-versus-host disease (GVHD) treatment Rezurock will be included in the national health insurance reimbursement list in the second half of this year. Sanofi Korea’s ROCK2 inhibitor Rezurock (belumosudil) recently passed the Health Insurance Review and Assessment Service (HIRA)’s Drug Reimbursement Evaluation Committee. Accordingly, the company is expected to soon enter pricing negotiations with the National Health Insurance Service. If the procedures proceed smoothly, reimbursement listing may be possible within the year. Rezurock, which received accelerated approval from the US FDA, was granted domestic approval in Korea in August last year, and was launched without reimbursement in November. It selectively inhibits ROCK2, a novel mechanism of action that targets inflammatory and fibrotic processes in chronic GVHD. Chronic GVHD is a complication that occurs in about half of patients who undergo allogeneic hematopoietic stem cell transplantation. Although the patient pool is relatively small, it affects about half of transplant patients and is a life-threatening condition that requires treatment. GVHD accounts for 37.8% of deaths in hematologic malignancy patients aside from relapse. With the number of hematopoietic stem cell transplants increasing every year (1,794 cases in 2023), the need for chronic GVHD treatment has also been on the rise. Within 3 years on average, 42% of transplant patients develop chronic GVHD, and 66% already are experiencing acute GVHD. However, a treatment gap exists in chronic GVHD. Both domestic and international treatment guidelines recommend steroids as first-line therapy, but it cannot be used in the long-term, as prolonged use can cause various systemic side effects of Cushing’s Syndrome, including osteoporosis, joint necrosis, organ failure, hyperlipidemia, gastrointestinal disorders, and growth retardation. While 96% of chronic GVHD patients receive steroids as first-line therapy, 70% move on to second-line treatment, and 50% eventually require third-line treatment. In cases where second-line treatment fails, there has been no effective third-line option, leaving patients to rely on combination therapy with steroids and immunomodulators. Also, 97% of chronic GVHD patients treated with steroids experience at least one complication, with infection being the most common (79.5%). Symptoms manifesting across multiple organs significantly lower quality of life, and host reactions in the lungs and liver can be particularly fatal. Against this backdrop, attention is on whether Rezurock will establish itself as a new treatment option through reimbursement coverage in Korea. Rezurock demonstrated a high overall response rate (ORR) of 75% in clinical trials targeting patients who failed two or more lines of systemic therapy, proving superior efficacy compared to existing treatments. In particular, it showed high response rates in previously hard-to-treat organs: 71% in joints, 39% in the liver, and 26% in the lungs. Professor Hee-Je Kim, Head of Hematology at Seoul St. Mary’s Hospital, said, “Forty-two percent of chronic GVHD patients develop symptoms across multiple organs, which significantly lowers their quality of life. Host reactions in the lungs and liver can have fatal consequences for hematologic cancer patients, so there has been an urgent need for a therapy that can effectively manage these.”
- 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.”
