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- 2026-03-10 07:55:18
- Policy
- UAE recognizes MFDS as reference body
- by Lee, Tak-Sun Jan 26, 2026 01:19pm
- Going forward, pharmaceutical products seeking registration in the United Arab Emirates (UAE) will be able to do so based solely on Korean regulatory approval.On the 16th, the Ministry of Food and Drug Safety (MFDS, Minister Yu-Kyoung Oh) announced that the Emirates Drug Establishment (EDE), the UAE’s medical products regulatory authority, has officially recognized Korea’s MFDS as an official Reference Regulatory Authority (RRA) in the field of medical products.Established in September 2023, the EDE is the UAE’s regulatory body responsible for the approval and safety management of pharmaceuticals, medical devices, cosmetics, health supplements, and other products within the UAE.This recognition represents a tangible outcome of the practical implementation of the Memorandum of Understanding (MOU) on biohealth cooperation signed and bilateral meetings between the MFDS and EDE following the Korea-UAE summit on November 18 last year. At the request of MFDS Minister Yu-kyoung Oh, the designation was formally conveyed through a letter from Fatima Al Kaabi, Director General of the UAE EDE. The MFDS stated that the move signifies that regulatory cooperation between the two countries has advanced beyond collaboration to a stage of institutional trust.Previously, pharmaceutical companies seeking UAE approval were generally required to obtain authorization from advanced regulatory authorities such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). With MFDS now recognized as a reference authority, companies can apply for UAE approval based solely on Korean MFDS approval. As a result, applicants may benefit from shortened review timelines, simplified regulatory procedures, and exemptions from manufacturing site inspections. This is expected to significantly shorten the time to enter the UAE market and enhance the global competitiveness and credibility of Korean products.Given that the UAE functions as a regulatory and distribution hub for the Middle East and North Africa (MENA) region and the Gulf Cooperation Council (GCC), the recognition is expected to serve as a stepping stone for future entry into the Middle Eastern market for pharmaceuticals and medical devices.This measure is particularly significant because it is based on the Ministry of Food and Drug Safety's (MFDS) full listing as a WHO World-Class Regulatory Authority (WLA) last August and the mutual trust built between the two agencies. The UAE has recognized the MFDS as possessing regulatory capabilities equivalent to those of advanced regulatory authorities, extending this recognition to medical products ranging from pharmaceuticals to biopharmaceuticals and medical devices.Since the establishment of the EDE, the MFDS has pursued multifaceted diplomatic efforts alongside the Embassy of the Republic of Korea in the United Arab Emirates (Chargé d'Affaires Jong-kyung Park) to secure recognition as a reference authority. These efforts included high-level meetings, signing memoranda of understanding, ministerial-level discussions, and bilateral meetings between agency heads.MFDS Minister Yu-kyoung Oh stated, “We are pleased that the UAE’s EDE has officially recognized the MFDS as a reference authority for medical products as a follow-up outcome of the Korea-UAE summit. With MFDS’s regulatory expertise now formally acknowledged in a key Middle Eastern hub country, we will actively support the global expansion of K-Biohealth products, including our pharmaceuticals, medical devices, and cosmetics.”
- Policy
- Yescarta’s second indication passes CDRC review
- by Lee, Tak-Sun Jan 23, 2026 08:39am
- Gilead’s CAR-T therapy Yescarta (axicabtagene ciloleucel) has secured reimbursement criteria, but only for its second indication.The Health Insurance Review and Assessment Service (HIRA) reviewed the reimbursement criteria for oncology drugs, including Yescarta, at the 1st Cancer Disease Review Committee meeting of 2026, which was held on the 21st.Following deliberation, reimbursement criteria were established only for the second indication of Yescarta, ‘Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) after two or more prior systemic therapies’.However, reimbursement criteria were not established for Yescarta’s first indication, ‘treatment of adult patients with DLBCL who relapse or are refractory within 12 months after first-line chemo-immunotherapy.’ Among the new drugs reviewed at the meeting, Yescarta was the only product to secure reimbursement criteria. Amgen’s Imdelltra and Janssen’s Rybrevant failed to establish reimbursement criteria. Rybrevant had drawn attention as a drug used in combination with Yuhan’s Leclaza (Lazertinib).In contrast, all drugs reviewed for reimbursement expansion, rather than new listing, successfully secured reimbursement criteria. These included Jakavi, pomalidomide products, Cabometyx, and Cyramza.Drugs that pass the Cancer Disease Review Committee will now proceed to the Drug Reimbursement Evaluation Committee for assessment of reimbursement adequacy. If approved, they will undergo final procedures through price negotiations with the National Health Insurance Service.
- Policy
- Celltrion drops export permit for FDA-Cleared HIV drug
- by Lee, Tak-Sun Jan 23, 2026 08:39am
- Celltrion has withdrawn the Korean export authorization for an HIV-1 infection treatment drug approved by the U.S. Food and Drug Administration (FDA).The company had pursued overseas HIV treatment markets, including the U.S., through the export authorization, but the move is being interpreted as a change in business strategy. Going forward, Celltrion is expected to focus more heavily on its biosimilar business.According to the Ministry of Food and Drug Safety, Celltrion Pharm withdrew the export license for ‘Temixys Tab 300/300mg (lamivudine/tenofovir disoproxil fumarate)’ as of the 7th. It also withdrew the export approval for the triple-combination HIV drug ‘Telumio Tab (tenofovir disoproxil fumarate, lamivudine, dolutegravir sodium)’.Temixys is a combination drug that combines the active ingredients of GSK's existing original antiviral drug, Zeffix (lamivudine), and Gilead's antiviral drug, ‘Viread (tenofovir)’. It is a product developed by Celltrion for use in combination with other antiretroviral agents to treat HIV-1 infection in adults and children weighing at least 35 kg.Celltrion announced that it received FDA approval for the sale of Temixys on November 16, 2018. This signaled competition with Gilead's ‘Truvada’ in the U.S. HIV treatment market.Prior to FDA approval, Celltrion had obtained export drug authorization from the Ministry of Food and Drug Safety on October 25 of that year, completing preparations for overseas sales.At the time, Celltrion stated it would supply high-quality treatment at a reasonable price compared to the original drug to HIV patients in the U.S. who were unable to access adequate medication due to high drug prices and insurance structures.The company also expressed plans to enter the international procurement market by securing supplier qualification from major global HIV drug procurement organizations, including the World Health Organization (WHO), the Global Fund, USAID, and the United Nations agency UNDP.To this end, the Celltrion Group explained that it had established a new chemical development team within Celltrion and launched a global chemical project.However, the withdrawal of this export license for the AIDS treatment suggests a shift in the company’s business strategy, 7 years after FDA approval. Domestic production of the AIDS treatment will now be discontinued following the authorization withdrawal. Celltrion is expected to focus more intensely on its biosimilar business going forward.
- Policy
- Ozempic, Rezurock, HyalFlex covered from next month
- by Lee, Jeong-Hwan Jan 23, 2026 08:39am
- Novo Nordisk’s type 2 diabetes treatment Ozempic (semaglutide) and Sanofi’s graft-versus-host disease (GVHD) treatment Rezurock (belumosudil) will be covered by Korea’s National Health Insurance starting on the 1st of next month.In addition, new reimbursement standards will be set for Jeil Pharmaceutical’s antibiotic Fetroja (cefiderocol) and Shinpoong Pharmaceutical’s osteoarthritis treatment HyalFlex (hexamethylenediamine cross-linked sodium hyaluronate).On the 22nd, the Ministry of Health and Welfare announced an administrative notice for a partial amendment to the “Detailed Standards and Methods for the Application of Medical Care Benefits (Pharmaceuticals),” which includes the establishment of reimbursement criteria for Ozempic, Rezurock, HyalFlex, and Fetroja.The Ministry plans to gather opinions until the 26th and then submit the agenda for deliberation at the Health Insurance Policy Deliberation Committee meeting on the 29th.For Ozempic Prefilled Pen, new coverage criteria will be established for its use as an adjunct to diet and exercise therapy in combination with oral agents or insulin in adult patients with type 2 diabetes that is not adequately controlled.Coverage for its use as part of the oral combination therapy applies to patients with a glycated hemoglobin (HbA1c) level of 7% or higher despite 2-4 months of combined metformin and sulfonylurea therapy, provided their body mass index (BMI) is 25 kg/m² or higher, or they are unable to use insulin. These patients are allowed reimbursed use of a triple therapy that includes Ozempic.However, if blood glucose is significantly improved with triple therapy, dual therapy with only metformin may also be reimbursed.Its use in combination with insulin (+metformin) is covered when HbA1c remains 7% or higher despite 2-4 months of basal insulin (insulin alone or with metformin) or when HbA1c remains 7% or higher despite combination therapy with Ozempic and metformin (+sulfonylurea).However, objective documentation (treatment history, HbA1c, BMI, etc.) must be submitted at initiation. HbA1c and BMI must be monitored every three months.The coverage period per prescription is up to 4 weeks for the initial 3 months when dosage adjustment is necessary per the approved indications, then up to 3 months thereafter.Rezurock is reimbursed for adults and pediatric patients aged 12 years and older who have failed at least two prior systemic therapies (including ruxolitinib).If ruxolitinib cannot be used due to adverse reactions or contraindications, coverage applies after failure of two or more alternative systemic therapies.If disease progression is absent at the 6-month and 9-month evaluations, and a response is confirmed at the 12-month evaluation, an additional 3 months of treatment is approved with reimbursement.Thereafter, continuous administration is approved upon confirmation of response at each 3-month evaluation. Re-administration is also reimbursed for patients who discontinued due to improvement.However, treatment must be discontinued if GVHD progresses (symptoms worsen or new symptoms appear), unacceptable adverse reactions that render use of Rezurock impossible occur, or a new systemic therapy is initiated after Rezurock.In addition, objective data (such as medical records and blood test results) regarding the target of administration for the initial dose of Rezurock, as well as response evaluations for continued administration or discontinuation, must be submitted.In the case of HyalFlex, coverage applies to patients with knee osteoarthritis of radiographic severity Kellgren-Lawrence grade I–III (mild to moderate).In the case of Fetroja, coverage is applied for complex urinary tract infections and hospital-acquired pneumonia when treatment with carbapenem antibiotics has failed, or when multidrug-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacteriaceae, or carbapenem-resistant Acinetobacter species are confirmed. And a physician’s treatment report must be submitted.For DongKwang Pharm’s Sulbacin Inj and other sulbactam/ampicillin combinations, coverage is approved beyond the approved indications when infection with carbapenem-resistant Acinetobacter baumannii is confirmed. The maximum daily dose is 27g, and the treatment period is within 14 days. Coverage may be approved for periods exceeding 14 days upon reference to the physician’s treatment report.In addition, Hanwha Pharmaceutical's Hepa-Merz Inj and other L-aspartic acid-L-ornithine preparations are covered when symptoms of latent or overt hepatic encephalopathy are present.The general principles for calcium and vitamin D-containing oral combination preparations now include hypoparathyroidism due to procedures such as total thyroidectomy.
- Policy
- Upcoming drug price reduction
- by Lee, Jeong-Hwan Jan 23, 2026 08:39am
- Major domestic pharmaceutical companies and mid-sized firms are repeatedly requesting modifications to the drug price reform plan, which was announced by the Ministry of Health and Welfare (MOHW) for implementation this year. The requests include a delay in its implementation and adjustments to the price reduction rates.The MOHW has yet to provide a clear response regarding the industry’s requests for a delay, changes to the reduction rates, or revisions to the preferential pricing details. Instead, the MOHW appears to be maintaining its "original plan to finalize the decision at the Health Insurance Policy Review Committee within the first quarter."In response, members of the National Assembly's Health Insurance Policy Review Committee, from the opposition party, plan to mediate between the pharmaceutical industry and the MOHW by hosting policy forums.On the 22nd, Rep. Baek Jong-heon of the People Power Party, alongside Reps. Han Ji-ah and Ahn Sang-hoon, will co-host a policy forum on drug price system reform on the 26th,. The forum will be organized by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA).During the forum, Attorney Park Kwan-woo from Kim & Chang will analyze the impact of the MOHW's drug price reform on public health, and Attorney Kim Hyun-wook from Shin & Kim LLC will present on sustainable measures to improve the drug price system.In the subsequent panel discussion, representatives from large domestic pharmaceutical companies, as well as the Korea Pharmaceutical Industry Cooperative, representing mid-sized and small firms, will participate to demand a delay in implementation, adjustments to the reduction rates, and revisions to the MOHW's preferential pricing plan.Specifically, the industry representatives, including Yoon Jae-Chun, Vice Chairman of Daewoong Pharmaceutical; Young-Joo Kim, CEO of Chong Kun Dang Pharm; and Cho Yong-jun, Chairman of the Korea Pharmaceutical Industry Cooperative, will be attending. From academia and patient groups, Professor Hye-Young Kwon of the Department of Health and Medical Administration at Mokwon University and Yoon Gu-hyun, President of the Korean Association for the Study of Liver, will attend. Yeon-sook Kim, Head of the Pharmaceutical Management Division at the MOHW, will represent the government.Attention is focused on whether this forum, which aims to seek a balance between the sustainability of health insurance and the development of the pharmaceutical and biotech industries, can narrow the gap in perspectives between the industry and the government.Multiple industry sources are appealing to the MOHW to accept the industry's proposed modifications proactively. The top priority for the pharmaceutical industry is delaying the committee's approval of the reform plan, currently scheduled for next month (February).On November 28 last year, the MOHW publicly announced the reform plan, which centers on cutting generic drug prices, and reported the implementation schedule to the committee.Several domestic pharmaceutical companies maintain that the implementation plan is too rushed, failing to ensure the predictability necessary for business management.The pharmaceutical industry is also demanding that the price-reduction rates for already-listed drugs (generics) be minimized. While the MOHW plans to lower the current generic price calculation rate from 53.55% to the 40% range, the industry argues this cut is excessive and insists it should be set at 48% to 50%.Additionally, they have requested that the implementation timing for generics listed since the 2012 price cuts be pushed back sufficiently to ensure predictability, and that the details of the preferential pricing plan be revised through consultation with the industry.An official from a top-tier domestic pharmaceutical company said,"It is frustrating that specific consultations or coordination of opinions between the MOHW and the industry regarding the reform plan have not yet taken place," adding, "We have requested several times that the short time between the announcement and the implementation date undermines predictability. A delay in the committee's approval is necessary."Another official from a top-tier company added, "Although several forums regarding the drug price reform have been held in and around the National Assembly, the atmosphere remains unclear as to whether the government will modify its plan or accept the industry's demands. If the drug price reform aims to foster the domestic pharmaceutical industry, the MOHW needs to commit practical and proactive consultations with the sector."
- Policy
- 'Key is in compensating innovation that exceeds price cuts'
- by Lee, Jeong-Hwan Jan 22, 2026 08:22am
- Director Yeon-sook Kim explains the drug pricing system reform plan.“While the media has largely focused on how the upcoming drug pricing system reform plan involves adjustments and reductions in drug prices, the true core of the policy is a fundamental strengthening of innovation-based compensation for pharmaceutical R&D beyond mere adjustments Whether it's a new drug or a generic, if it demonstrates innovation, we will increase drug price compensation and extend the preferential period from the current one year to three years plus alpha, creating a virtuous cycle of innovation in the pharmaceutical industry.”The Ministry of Health and Welfare reiterated its stance that the core keywords of the drug pricing system reform plan announced for implementation this year are ‘innovative new drugs’ and ‘resolving supply instability,’ and that it will enhance the tangibility of preferential drug pricing incentives for pharmaceutical companies that achieve these goals.This involves establishing a drug pricing compensation structure proportional to the level of investment in new drug R&D and extending the preferential period from the current one year to ‘three years or more.’Regarding resolving supply instability, the government announced plans to guarantee preferential treatment for up to 10 years for drugs using self-manufactured APIs and for essential medicines made with domestic APIs.The Ministry's policy is to overhaul the post-listing drug price control system to enhance predictability for pharmaceutical companies while reducing the administrative burden on the government.Kim outlined the reform and its operational roadmap on the 21st at the 55th Dailypharm Future Forum held at the Catholic University of Korea’s Songeui Campus Institute of Biomedical Industry.“The current pricing system has limitations in supporting innovation and essential drug stability”The Ministry of Health and Welfare maintains that the current drug pricing system has clear limitations in reliably ensuring the creation of innovative new drugs and stable patient access to essential medicines.It was further diagnosed that, compared to other countries, South Korea's generic drug prices are relatively high, leading to stagnation in innovation through new drug R&D.The ministry believes that many pharmaceutical companies remain entrenched in business models centered on high generic drug prices, neglecting new drug R&D.At the same time, population aging and rising pharmaceutical expenditures have significantly increased drug spending, making it increasingly difficult to strike a balance between fostering an innovation-based pharmaceutical industry ecosystem and ensuring the sustainability of the National Health Insurance system.“Drug price reform to foster a new drug ecosystem and ensure a stable supply of essential medicines”To strengthen the new drug development ecosystem, the ministry plans to shorten the reimbursement listing period for rare disease treatments to within 100 days and to advance cost-effectiveness evaluations for treatments targeting severe and intractable diseases.To facilitate the early domestic introduction of innovative medicines, the scope of the flexible drug pricing contract system should be expanded, and compensation should be provided proportional to the level of innovation creation efforts, such as new drug R&D.This includes strengthening R&D-linked pricing incentives and ensuring stable preferential periods.For essential medicines, the ministry will overhaul the exit-prevention drug system across the entire lifecycle, strengthen the effectiveness of preferential treatment for essential drugs, and reinforce coordination between relevant policies.Through a public–private consultative body, supply stability medicines will be monitored throughout their lifecycle and addressed proactively.The government will also strengthen monitoring of pharmaceutical supply and distribution and implement tailored measures based on the causes of shortages.In particular, for medicines with unstable supply, the government plans to support substitution prescribing and dispensing at the national level.“Generic pricing rate to be adjusted to the 40% range… stepwise cuts to apply from the 11th product”The most controversial part of the reform among domestic pharmaceutical companies is the rationalization of price management.The ministry plans to revise the pricing structure based on international benchmarks, with the key change being a reduction of the generic pricing rate from the current 54.55% to the 40% range.The stepwise price reduction system will also be strengthened. Currently, stepwise cuts apply from the 21st product of the same ingredient, with the price set at 85% of the lowest price.Under the reform, price cuts will apply from the 11th product, and the reduction rate will be set at an additional 5 percentage points below the first generic price.The Ministry of Health and Welfare anticipates that this reform will significantly increase the perceived benefits for pharmaceutical companies by applying price premiums primarily to those contributing to new drug innovation and supply stability.For price reductions of already-listed generics, items maintaining a price level of 53.55% since the 2012 blanket price reduction adjustment will be sequentially reduced over three years.The post-listing management system will standardize the timing for adjusting price reductions linked to expanded usage and price-volume linkage agreements. Actual transaction price surveys will be restructured to a market competition-linked model. The reimbursement adequacy reassessments will be restructured around clinical evidence.Kim emphasized, “Korea is at a critical moment, both a crisis and an opportunity, to build an innovative new drug ecosystem. We will raise pricing rewards for innovation and significantly extend preferential periods to send a clear signal toward innovation.”She added, “Even if a product is not a new drug, it will receive preferential pricing if it contributes to a stable supply of essential medicines. For exit-prevention drugs, we will collaborate with organizations like the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and the Health Insurance Review and Assessment Service to identify tasks for improving drug pricing levels or systems after conducting research studies. We will ensure that the number of generic items remains at an appropriate level, avoiding excessive proliferation.”“When too many products of the same ingredient are listed at once, prices will be adjusted according to stepwise criteria after an appropriate period. For already-listed products, prices that have remained high since 2012 will be reduced gradually and sequentially over three years.”
- Policy
- Gov't addresses unstable supply of essential drug·API
- by Lee, Jeong-Hwan Jan 22, 2026 08:22am
- To strengthen response to drug supply instability this year, the government is expanding support for pharmaceutical companies producing items in short supply, improving self-sufficiency in active pharmaceutical ingredients (APIs), and enhancing the manufacturing capabilities for biopharmaceutical raw materials and components.On the 20th, Yim Kang-seop, Head of the Division of Health Industry at the Ministry of Health and Welfare (MOHW), met with the Korea Special Press Association to explain measures to address the supply chain crisis facing the pharmaceutical and biotech industries.To address structural limitations in the drug supply system, the MOHW has secured a total budget of KRW 15.6 billion for this year and is pursuing five projects.The projects include support for production facilities and equipment for companies supplying drugs with unstable supply, support for stockpiling core medicines, support for diversifying API procurement, user testing support for bio-based raw materials and components, and manufacturing support for domestic raw materials and components.First, the MOHW will increase the number of pharmaceutical companies receiving budget support for producing drugs with unstable supply from 1 last year to 4 this year.This project, launched for the first time last year, currently supports 'Boryung Questran Powder For Suspension (Cholestyramine resin),' a bile acid sequestrant-based hyperlipidemia treatment, and the only drug safe for use by pregnant women and children.Yim plans to reorganize the program to allow subsidy support for up to two years, taking into account the actual time required for pharmaceutical companies' demand and equipment setup, while also increasing the number of target items.To produce API domestically, new projects starting this year include support for diversifying raw material procurement, which helps consortia between raw material suppliers and finished product manufacturers, and a project to cover stockpiling costs to ensure a stable supply of medicines even during crises.In collaboration with the Korea Health Industry Development Institute (KHIDI), the MOHW will also launch initiatives for user testing and manufacturing support to promote the use of domestically produced biopharmaceutical raw materials and components.Yim explained, "Korea's self-sufficiency rate for API is currently low, in the low 20% range. He noted that dependence on specific countries, such as China and India, is high, and that supply chain risks are growing as countries shift toward protectionist trade policies," adding, "To resolve these structural issues, the ministry is launching new projects this year to directly support supply chain stability, including the localization of raw materials and components, stockpiling core medicines, and user testing for bio-based materials.Yim added, "The ministry is ensuring that preferential drug pricing for the use of domestic raw materials and essential medicines is reflected in the drug price system reform plan. The goal is to create a structure that links budget support not only to simple raw material procurement but also to the improvement of facilities and equipment. Enhancing overall supply chain stability remains the core of this year's projects."Yim emphasized, "The issue of localizing and increasing the self-sufficiency rate of raw materials and bio-based components has been repeatedly pointed out during parliamentary audits," and added, "The MOHW will establish a research commission to develop a roadmap for API self-sufficiency and identify additional tasks through a two-track strategy that links the budget to pharmaceutical policies."
- Policy
- MFDS reviews mutagenicity of clarithromycin impurity
- by Lee, Tak-Sun Jan 21, 2026 09:07am
- While investigations into nitrosamine impurities in the antibiotic clarithromycin are underway, the Ministry of Food and Drug Safety (MFDS) is reportedly also reviewing their mutagenicity.The European Medicines Agency (EMA) has already concluded that the clarithromycin-related nitrosamine impurity is non-mutagenic.If the MFDS also concludes that there is no mutagenicity, the threshold for excessive nitrosamine detection in clarithromycin would be removed, making quality control significantly easier for the pharmaceutical industry.According to the MFDS on the 20th, nitrosamine impurities (N-nitroso-N-desmethyl clarithromycin) were detected in excess in finished drug products using clarithromycin ingredients from India. Consequently, the MFDS has ordered an investigation into 77 companies holding related items.The MFDS orders an investigation within one month for known impurities and a three-month investigation for relatively unknown impurities.The threshold for nitrosamine impurities in clarithromycin has already been established. In December 2023, the acceptable intake was set at 1,500 ng per day.An official from the MFDS stated, "Impurities were first detected in raw materials from India, and excessive amounts were also confirmed in one domestic finished drug product using those materials. We have therefore issued investigation orders to all companies with relevant items."Upon receiving reports of the investigation results from these companies, the MFDS will review usage patterns and supply status before ordering product recalls.However, it has been noted that the MFDS is also reviewing the mutagenicity (a chemical reaction to cause genetic mutations) of the clarithromycin nitrosamine impurity.While the European EMA has already concluded it is non-mutagenic, the U.S. FDA is currently conducting review.If the impurity is determined to be non-mutagenic, it would no longer pose a regulatory issue, even if detected in excess, since the acceptable limit would be deleted.The MFDS official explained. "We are conducting the mutagenicity review and the impurity investigation concurrently," adding, "If the conclusion that clarithromycin nitrosamine is non-mutagenic had reached first, this investigation would not have taken place."Meanwhile, clarithromycin is a widely used antibiotic for infections of the upper and lower respiratory tracts.
- Policy
- Generic development for low-strength Rosuzet to begin soon
- by Lee, Tak-Sun Jan 20, 2026 07:54am
- Hanmi's Rosuzet TabDevelopment of generic versions of Hanmi Pharmaceutical’s low-strength combination lipid-lowering drug Rosuzet has begun, as its re-examination period is set to end in September next year.The low-strength Rosuzet formulation, which combines rosuvastatin 2.5 mg and ezetimibe 10 mg, was approved in September 2021 and designated as a re-examination drug for six years.The Ministry of Food and Drug Safety (MFDS) approved Shinil Pharma’s bioequivalence study for its generic candidate SIL1124 on the 13th. The reference drug is Rosuzet 10/2.5 mg, and the study will be conducted in 60 healthy adult volunteers.This marks the start of generic development for Rosuzet 10/2.5 mg. The product was approved on September 24, 2021, and its re-examination period will end on September 23, 2027.Generic applications may be submitted only after the re-examination period expires. The initiation of the bioequivalence study is therefore viewed as part of preparations to meet the regulatory filing timeline. In addition to Shinil Pharma, more companies will likely begin bioequivalence studies in the near future.More than 50 pharmaceutical companies have already expressed interest in developing their generic versions.In addition to the re-evaluation exclusivity period, patents listed in the Green List (specifically, an oral combination tablet containing ezetimibe and rosuvastatin, scheduled to expire on November 29, 2036) are also one hurdle for generic developers.As a result, many generic companies have launched patent challenges. To date, a total of 56 patent avoidance (non-infringement confirmation) trials, including one filed by Shinil Pharma, are currently pending before the Intellectual Property Trial and Appeal Board.If the Patent Trial and Appeal Board rules in favor of the generic companies, this will resolve their patent issues. They could then launch generic versions by September next year, upon expiry of the re-examination period.Low-strength Rosuzet gained rapid popularity following its launch, as it reduces the risk of adverse events such as diabetes and myopathy associated with high-dose statin therapy, while offering superior efficacy compared to statin monotherapy. The product is reported to generate annual sales exceeding KRW 20 billion.Hanmi Pharmaceutical demonstrated Rosuzet’s efficacy and safety through a Phase III clinical trial involving 279 Korean patients. The study was published in the online edition of the international journal Clinical Therapeutics.Currently, 12 products containing the same active ingredients as low-strength Rosuzet have already been approved. However, these products are not generics that completed bioequivalence studies using Rosuzet 10/2.5 mg as the reference drug; instead, they were approved as data-submission products based on independent clinical trials. Their re-examination periods are also identical to those of Rosuzet 10/2.5 mg.As the recent trend in new drug development shifts toward anticancer agents and orphan drugs, new drugs for chronic diseases like hypertension, hyperlipidemia, and diabetes have become scarce. As a result, domestic generic companies that rely on physician-centered marketing of generic chronic disease drugs are facing growing limitations in business development.In this environment, the upcoming expiration of exclusivity for a blockbuster drug like low-strength Rosuzet is expected to draw strong interest from generic manufacturers. Accordingly, generic activity is expected to accelerate ahead of the re-examination expiry in July next year.
- Policy
- ‘Will create first FDA-approved Korean drug by 2030’
- by Lee, Jeong-Hwan Jan 19, 2026 09:02am
- Amid the Ministry of Health and Welfare's ambition to foster Korea’s pharmaceutical industry by establishing a new dedicated “Division of Pharmaceutical and Bio Industry,” Kang-Seop Lim, its first director, expressed his ambition. He said, “We will create cases where domestically developed new drugs independently obtain approval from the U.S. Food and Drug Administration (FDA).”Rather than relying on licensing-out deals to global pharmaceutical companies for overseas market entry, what the government wants to do is support Korean pharmaceutical firms in completing Phase III clinical trials and securing FDA approval on their own, paving the way for direct global commercialization of Korean blockbuster drugs.On the 18th, Director Lim met with the Ministry of Health and Welfare's press corps and stated, “Our goal is to create a successful case of a fully developed Korean drug completing Phase III trials, securing FDA approval, and being sold directly in the U.S. market within five years. We will make this year the starting point, with the aim of achieving this milestone by 2030.”When asked what administrative priorities he would focus on this year as the inaugural head of the new division, Director Lim cited “developing a finished new drug that successfully completes Phase III clinical trials, secures FDA approval, and achieves direct sales” as the top priority.While the ministry will continue to support technology licensing deals, Lim emphasized that the new policy direction is focused on enabling Korean-developed drugs to enter global markets independently, without relying on multinational pharmaceutical companies.To this end, MOHW will operate a dedicated fund specifically supporting Phase III clinical trials for new drug candidates showing potential for final regulatory approval.The Ministry has already allocated KRW 60 billion in government capital in this year's budget proposal for this purpose. Combined with matching funds from the Fund of Funds, it plans to establish a ‘Phase III Clinical Trial Specialized Fund’ totaling KRW 150 billion.Lim said, “Last year, Korea recorded its highest-ever technology licensing exports, yet there are still very few cases of fully developed Korean drugs being launched overseas. Now is the time for Korea to take the lead in completing Phase III clinical trials and securing FDA approval.”“Looking at the K-Bio Vaccine Fund, roughly 50% went to preclinical research and 50% to Phase I–II trials, but there were virtually no Phase III investments. That gap is something we are now determined to fill, which is why we decided to establish a Phase III specialized fund based on this year's budget.”He added, “Of the KRW 150 trillion National Growth Fund, KRW 11.6 trillion will be allocated to the pharmaceutical, bio, and vaccine sectors over five years. We are also considering connecting this funding to late-stage clinical investments. We will signal that pharmaceutical and biotech companies can secure funding even in late-stage clinical trials, enabling them to plan their clinical and business strategies.”Lim added that the Ministry of Health and Welfare also plans to continue supporting technology licensing.This means the Ministry will assist pharmaceutical and biotech ventures and startups in growing from small and medium-sized enterprises (SMEs) to mid-sized companies, and their search for opportunities for further expansion, using technology exports as a starting point.The Ministry has allocated KRW 10.4 billion for its global open innovation budget and is developing collaboration plans to combine this with the Ministry of SMEs and Startups' budget to further expand the scale of the program.In the first half of the year, MOHW will establish a consultative body with biotech venture companies to gather feedback on regulatory reform and policy support. These discussions will feed into regulatory modernization initiatives and next year’s budget planning.Lim stated, “The number of companies to be supported through the global open innovation budget is around 32. For platform technology development R&D, we are considering planning it this year and including it in next year's budget. While existing R&D has primarily focused on candidate substances, preclinical studies, and clinical trials, we now intend to support investment in the platform technology itself.”He further noted, “The establishment of a dedicated department under the name ‘Division of Pharmaceutical and Bio Industry’ carries significant symbolic meaning. I feel a sense of responsibility. The follow-up budget and administrative measures for the Pharmaceutical and Bio-Health Leap Strategy unveiled last September will be fully implemented starting this year. We will present a changed approach to the industry, and the first message will be the announcement of the revised Innovative Pharmaceutical Company Certification System.”
