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- 2026-03-10 07:05:12
- Policy
- Contraindication guidelines to flu vaccine cut down in KOR
- by Lee, Tak-Sun Sep 23, 2025 06:07am
- The Ministry of Food and Drug Safety (MFDS) plans to significantly reduce the list of contraindications for influenza (flu) vaccines. The MFDS has decided to create a new set of recommended guidelines because the previous contraindications were deemed inconsistent with current clinical practice and international standards. The MFDS collected public opinion on the recommended guidelines for contraindications and precautions for inactivated influenza vaccines until September 19. Most flu vaccines are inactivated vaccines (made from killed viruses). The new recommendations reduced the number of contraindications to two: ▲Individuals with a severe hypersensitivity reaction to any of the vaccine's components (active ingredients and excipients) or to egg ingredients (ovalbumin, egg protein), formaldehyde, or polysorbate ▲Individuals who have previously had a severe hypersensitivity reaction (e.g., anaphylaxis) to an influenza vaccine. In addition to contraindications, a new category for cautious administration group was also established. This category includes three key points: ▲Caution should be exercised when administering intramuscular injections to individuals with thrombocytopenia or coagulation disorders, as bleeding may occur ▲For individuals who have a history of developing Guillain-Barre syndrome or other neurological disorders within six weeks of a previous influenza vaccination, the benefits and risks of vaccination should be carefully considered ▲Vaccination should be postponed for individuals with a severe febrile illness or acute illness. According to the current vaccination approval, the listed contraindications are over 10, where items may vary. For example, ▲Individuals with fever or severe malnutrition ▲Patients with cardiovascular diseases, kidney disease or liver disease whose disease states are in aggressive state, middle state, or active state ▲Patients with acute respiratory disease or active infectious disease. However, in clinical practice, these patient groups, particularly those with chronic diseases, are strongly encouraged to get vaccinated. The MFDS official explained, "The influenza vaccines were approved a long time ago, so they don't align with today's reality or international standards. This is why we have prepared these new recommendations." The new recommendations were established at the request of pharmaceutical companies. Meanwhile, approximately 28 million doses of flu vaccine are scheduled to be supplied in the second half of this year. Seven domestically manufactured products, including those from companies such as Green Cross and SK Bioscience, as well as seven imported products from companies like GSK and Sanofi, will be available. Sanofi announced that it has been supplying its trivalent flu vaccine, 'Vaxigrip,' nationwide since September 3.
- Policy
- Will access to aHUS drugs improve in Korea?
- by Jung, Heung-Jun Sep 23, 2025 06:06am
- The prior approval criteria for receiving reimbursement of atypical hemolytic uremic syndrome (aHUS) drugs, which had long been criticized for impeding patient access, have been improved. This issue was raised during last year’s National Assembly audit as well. At that time, Rep. Yoon Kim (Democratic Party of Korea) pointed out the low approval rate for Soliris (eculizumab). With approval rates hovering at only 30–40% annually, patient access was significantly limited, leading to calls for easing the pre-approval requirements. The Ministry of Health and Welfare (MOHW) is currently collecting public opinion on the proposed partial amendment to the ‘Detailed Rules on the Standards and Methods for Applying Health Insurance Benefits (Drugs),’ from September 18 to 22. The revised proposal specifies the criteria for insurance reimbursement and relaxes or adds detailed requirements on hemoglobin and haptoglobin levels, etc. Previously, the reimbursement criteria required meeting all of the following: ▲ Platelet count below the lower limit of normal at the institution, ▲Presence of schistocytes, ▲ Hemoglobin < 10 g/dL, ▲and Lactate dehydrogenase (LDH) ≥ 1.5 times the upper limit of normal. The revised criteria are as follows: ▲Platelet count < 150×10⁹/L, ▲ Presence of schistocytes, ▲ Hemoglobin < 12 g/dL (or < 11 g/dL for children under 5), ▲ LDH above the upper limit of normal, ▲Haptoglobin below the lower limit of normal. For renal impairment, the wording was changed from “patients” to “cases,” but the thresholds remain the same: ▲≥20% decline in eGFR, ▲Serum creatinine above the age- and sex-specific upper limit of normal. The ADAMTS-13 testing requirement was also specified. Tests must be conducted before plasma exchange or plasma infusion, before the 4th treatment session, or at least 7 days after stopping treatment. However, the criterion based on serum creatinine levels was removed. In addition, a new criterion was added to allow reimbursement even if other requirements were not met. Specifically, if end-stage renal disease due to aHUS is suspected and the drug is required before or after kidney transplantation, coverage may be granted on a case-by-case basis. In addition, the following conditions were removed from the exclusion criteria: ▲ Hemolytic uremic syndrome caused by Shiga toxin, ▲Transplantation, ▲Fibrin thrombosis, ▲paroxysmal nocturnal hemoglobinuria, catastrophic hyperlipoproteinemia, ▲ Sepsis, ▲and other secondary hemolytic uremic syndromes. The revised proposal applies identical detailed recognition criteria to eculizumab (Soliris) and ravulizumab (Ultomiris). The MOHW plans to implement the revised criteria starting October 1, after completing the public opinion collection period.
- Policy
- Bylvay will be reimbursed from next month in Korea
- by Lee, Jeong-Hwan Sep 19, 2025 06:12am
- Bylvay Cap (odevixibat), a treatment for progressive familial intrahepatic cholestasis (PFIC), will be covered by Korea’s National Health Insurance starting on October 1. Bylvay Cap was selected as the first drug for the “Approval–Evaluation–Negotiation parallel pilot program,” and underwent an expedited reimbursement process. The preterm labor prevention drug Tractocile Inj (atosiban) will also be reimbursed starting at the same time. The Ministry of Health and Welfare announced on the 18th a partial amendment to the Detailed Rules on the Standards and Methods for the Application of Medical Care Benefits. Tractocile Inj will be reimbursed for up to 4 cycles within its approved indication. If administered beyond the recognized cycles, the full drug cost must be borne by the patient. Bylvay Cap 200mg will be reimbursed for PFIC patients aged 3 months or older who meet all of the following conditions: Patients with moderate or severe pruritus who have serum bile acid (sBA) concentrations of 100μmol/L or higher and a CGIS score of 2 or higher. Reimbursement will be excluded if any of the following conditions apply at treatment initiation or during treatment: Patients who have undergone liver transplantation, patients with decompensated cirrhosis, patients with hepatic decompensation (such as variceal bleeding, ascites, hepatic encephalopathy) Reimbursement for an additional 6 months is granted if the treatment response is satisfactory at the 6-month evaluation following the first dose. Thereafter, evaluation is conducted every 6 months, and continued administration is approved if the treatment response is maintained. Combination drugs containing empagliflozin (SGLT-2 inhibitor) and sitagliptin — such as Empasita M SR Tab 10·100·1000mg — will also be reimbursed, starting October 24. Cypol-N Soft Cap, Cellcept Capsules, Prograf Cap/Inj, and MTX will have their reimbursement scope expanded starting October 1. In addition to the existing indications, they will now be covered for polymyositis and dermatomyositis. Mabthera Inj (lituximab) and other agents will receive extended reimbursement, now covering “adult refractory nephrotic syndrome, polymyositis, and dermatomyositis.”
- Policy
- MFDS, "Increase in fees will expedite biosimilar approval"
- by Lee, Tak-Sun Sep 18, 2025 06:02am
- The Ministry of Food and Drug Safety (MFDS) has announced that it will expedite biosimilar approvals in relation to a recent "increase in approval fees." The MFDS plans to establish a dedicated review team to provide approval and review services commensurate with the new fees. The MFDS issued an administrative announcement on September 12 regarding a partial amendment to the 'Regulations on Fees for Pharmaceutical Approvals, etc.', which primarily details the reorganization of approval fees for biosimilars (biological medicines). According to the amendment, the approval fee for biosimilars will increase to KRW 310 million, a significant jump from the previous KRW 8.031 million. Also, the MFDS announced that it will shorten the approval period from the current 406 days to 295 days. According to the amendment, the approval fee for biosimilars will increase to KRW 310 million, a significant jump from the previous KRW 8.031 million. An MFDS official stated on September 16 to a group of specialized journalists, "Similar to our innovative plan for new drug approvals, we will expand customized consultations through the operation of a dedicated review team." The MFDS plans to establish a dedicated review team (10-15 reviewers) from various fields to conduct biosimilar reviews in areas such as ▲safety and efficacy ▲quality management ▲Good Manufacturing Practice (GMP) ▲Good Clinical Practice (GCP). Specifically, the teams will be organized by product, centered around the Biopharmaceutical Policy Division's 'Bio Approval TF' within the Biopharmaceuticals and Herbal Medicines Bureau. An official from the Bio Approval TF said, "We have received positive feedback from the industry since implementing the innovative plan for new drug approvals in January," and added, "The dedicated teams will be structured similarly to the new drug innovation plan and are expected to provide swift and accurate approval reviews for biosimilar products." The MFDS also announced plans to prioritize GMP inspections for biosimilar products. The core of this initiative is to conduct GMP evaluations and on-site inspections within 90 days of submitting the approval application. The agency also plans to recruit highly qualified reviewers. Another MFDS official stated, "This matter has not yet been finalized, so I must be cautious in expressing an opinion," and added, "If the biosimilar approval fee increase is finalized, we plan to supplement our staff with highly qualified reviewers to enhance our approval and review capabilities, thereby improving patient access to treatment in Korea. We will do our utmost to respond to the growing demand for biosimilar products." The industry believes that if GMP inspections are completed within 90 days, the approval speed could increase even further. An industry official said, "The demand for biosimilar products has been increasing recently due to the rise in chronic diseases and the aging population," and added, "Because of this, pharmaceutical companies are seriously beginning the development and approval applications for biosimilar products. If the fee increase becomes a reality, the shortened approval timeline will likely accelerate product launches." According to the '2024 Drug Approval Report' released by the MFDS, biosimilar products (equivalent biological medicines) recorded a total of 18 items (10 APIs), an increase of 6 items from the previous year, marking the highest number of approvals since the first product approval in 2012. More than half of these (13 items, 7 APIs) were domestically developed in Korea, suggesting that the domestic biosimilar industry, led by Celltrion and Samsung Biologics, has gained global competitiveness.
- Policy
- Reimb listing a hurdle for Dutasteride + Tadalafil combos
- by Jung, Heung-Jun Sep 18, 2025 06:02am
- The dutasteride-tadalafil combination was approved in January for the treatment of benign prostatic hyperplasia (BPH), but has failed to clear the reimbursement hurdle, which is delaying the drug’s market launch. Four companies – Dongkook Pharmaceutical, Dong-A ST, DongKoo Bio&Pharma, and Shinpoong Pharm - are reportedly discussing a non-reimbursed launch, though some differences in opinion remain. According to industry sources on the 16th, the four companies are debating whether a non-reimbursed launch would have sufficient market potential or whether it would be better to attempt another reimbursement bid. If they proceed with a non-reimbursed launch, they must also decide on the appropriate timing. Dongkook Pharmaceutical (Uresco Tab), Dong-A ST (Dutana Tab), DongKoo Bio&Pharma (Uroguard Tab), and Shinpoong Pharm (Avocial Tab) drew attention in January for obtaining the world’s first approval of fixed-dose dutasteride-tadalafil combinations. Although the companies applied for reimbursement listing, concerns over potential misuse became an obstacle. In particular, the non-reimbursed component of tadalafil was said to have been the sticking point. An industry official commented, “If launched without reimbursement, we need to assess how much market potential it would really have. Some companies also favor making another reimbursement attempt, so consensus must be reached.” The companies are in a difficult position, as launching without reimbursement and then reapplying for listing is not an easy path. The dutasteride-tadalafil combination was first developed by Dongkook Pharmaceutical in 2012 and has come to fruition after 13 years of research. A Dongkook Pharmaceutical representative said, “No definite timeline has been set for a non-reimbursed launch yet, and discussions are still ongoing with the three partner companies.” The companies hold exclusive sales rights for 6 years following approval. The longer the launch is delayed, the shorter the effective exclusivity period becomes. According to IQVIA, the market for dutasteride has been steadily growing alongside the hair loss treatment market. Last year, sales of the original product Avodart reached KRW 42.9 billion, while generics totaled KRW 49.4 billion.
- 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.
- 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.”
- 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."
- 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.
