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- 2025-12-20 18:32:06
- Policy
- NHIS completes pricing negotiations for Vemlidy, Brukinsa
- by Lee, Tak-Sun May 20, 2024 05:41am
- Negotiations between the National Health Insurance Service (NHIS) and pharmaceutical companies have been completed for 5 morning sickness drugs, hepatitis B drug Vemlidy Tab (tenofovir alafenamide hemifumarate), and Chinese company BeiGene Korea's new cancer drug Brukinsa Cap (zanubrutinib). The 5 morning sickness drugs underwent new drug pricing negotiations, Vemlidy underwent the price-volume agreement negotiations, and Brukinsa underwent a negotiation to expand its scope of use. According to the industry on the 17th, the NHIS recently updated its list of drugs completed negotiations and announced the completion of negotiations of the drugs listed above. The 5 morning sickness drugs that have completed negotiations are Hyundai Pharm’s ‘Diclectin Enteric Coated Tab,’ Boryung Biopharma's ‘Easy Morning Enteric Coated Tab,’ Dong Kook Pharmaceutical's ‘Mommyrectin Enteric Coated Tab,’ Shin Poong Pharm’s ‘Dinerzia Enteric Coated Tab,’ and Hanwha Pharma’s ‘Prelectin Enteric Coated Tab.’ These drugs are pyridoxine hydrochloride and doxylamine succinate combinations and are the only drugs indicated to treat nausea and vomiting during pregnancy in women who do not respond to conservative management in Korea. The government has been pushing for health insurance coverage of these items since last year as part of its policy to support pregnant women. The NHIS has been negotiating drug prices since mid-March and recently reached an agreement with the 5 pharmaceutical companies. Vemlidy has reportedly completed negotiations under ‘Type B’ of the Price-Volume Agreement system. The drug underwent the same type of negotiations last year, which resulted in a 4.7% reduction in its insurance cap price As the most-used drug in the hepatitis B treatment market, Vemlidy’s insurance claims continue to grow. Last year's prescription sales amounted to KRW 61.9 billion based on UBIST, up 26% YoY (from KRW 49.2 billion the previous year). PVA Type B is applied to drugs ▲whose insurance price had been adjusted under ‘Type A,’ or ▲that were listed for over 4 years without undergoing pricing adjustments under Type A and whose claims amount increased over 60% from the previous year; or ▲increased by 10% but the amount exceeds 5 billion. Vemlidy was found to have satisfied the conditions. Brukinsa was approved in May last year as monotherapy for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy. In March, the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee recognized the adequacy of expanding reimbursement for Brukinsa as treatment of mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and has been in negotiations with the agency ever since. The items that successfully completed negotiations will the NHIS will reported to the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare next week for reimbursement listing.
- Policy
- Erwinase price increases… Imfinzi renews RSA
- by Lee, Tak-Sun May 20, 2024 05:41am
- Immunotherapy drug for cancer, Imfinzi inj The price of Erwinase Inj (L-asparaginase), used to treat patients with acute lymphoblastic leukemia (ALL), is expected to increase. Additionally, Imfinzi, an immunotherapy drug for cancer, also succeeded in renegotiating risk-sharing agreements (RSA). Rhopressa, a treatment for open-angle glaucoma and intraocular pressure, has entered negotiations with the National Health Insurance Service (NHIS). According to industry sources on the 16th, the NHIS posted these negotiation results and schedules. Clinigen’s Erwinase inj was first listed in August 2019. The listing took 12 years and 5 months to be granted after the approval in South Korea. It can be covered by reimbursement when used in combination with other chemotherapy agents in patients with acute lymphoblastic leukemia (ALL) hypersensitive to Escherichia coli-derived asparaginase. At the time of reimbursement listing, the price of Erwinase was negotiated for KRW 520,000 per bottle, which was lower than the lowest price among A7 countries (KRW 702,564 (UK)). Erwinase Inj has been in negotiations with the NHIS regarding drug price increases through the adjustment application, and it recently met in agreement. The price increase has not been disclosed. In March, Erwinase Inj was granted for the changes of administration requirements from Grade 3 to Grade 2 from the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA). AstraZeneca’s Imfinzi (Durvalumab) had an RSA agreement when it was reimbursement listed in April 2020. The contract ended in March. Despite of the contract ending, it continued negotiations with the NHIS and succeeded recently in negotiations. Imfinzi is covered by reimbursement for the treatment of patients with unresectable non-small cell lung cancer (NSCLC) who have not progressed after platinum-based concurrent chemoradiotherapy (CCRT). It is pursuing reimbursement expansion for bile duct cancer. The NHIS also disclosed pharmaceuticals under negotiations. As reported, Novartis' Ilaris injection (canakinumab) initiated negotiations in May. Ilaris passed the DREC review of the HIRA through real-world evidence (RWE) submission as a pharmacoeconomic evaluation exemption drug, following the principle of post-listing assessment. It is subject to a total cap on the type of reimbursement with RSA. Santen's glaucoma treatment, Rhopressa Ophthalmic Soln, has also entered negotiations. In April, it received conditional approval from DREC for reimbursement if priced below the evaluated amount. Subsequently, the pharmaceutical company has accepted the evaluated amount set by the DREC. Given that most pharmaceutical companies tend to take the pricing set during this period as the basis for price negotiation exemption, it is anticipated that negotiations with the HIRA will focus on expected reimbursement amounts.
- Policy
- Daewoong develops 'Olumiant' generic…starts clinical trials
- by Lee, Hye-Kyung May 17, 2024 05:47am
- Daewoong Pharmaceutical develops a generic version of Lily Korea’s JAK inhibitor Daewoong Pharmaceutical has started developing product to compete against Lily Korea’s JAK inhibitor 'Olumiant (baricitinib).' Olumiant was approved by the Ministry of Food and Drug Safety (MFDS) in December 2017. It is used for treating adult patients with moderate-to-severe rheumatoid arthritis who do not respond well to disease-modifying antirheumatic drugs (DMARDs) and have no tolerability. The patents for Olumiant 2/4 mg is registered until July 2032. Therefore, pharmaceutical companies in South Korea can only launch their generics after avoiding patent infringement. On May 13, the MFDS approved clinical trials for Daewoong’s 'DWJ1607' and 'DWC202401' to conduct bioequivalence testing. DWJ1607 is targeting rheumatoid arthritis. The trial included 'baricitinib' as primary and secondary endpoints for evaluating the product’s efficacy. The trial is likely for the development of a generic version of Olumiant. Daewoong will conduct the DWJ1607 clinical trial, which will involve 44 adults aged 18 to 65 and 65 and over at H Plus Yangji Hospital. Olumiant, an oral medication taken once daily, improves convenience for patients who are averse to injections and those with rheumatoid arthritis who find it difficult to visit hospitals frequently. After being approved in 2017, Olumiant has been covered by health insurance as a secondary treatment equivalent to the bioequivalent agent since November 2018. In particular, at the time of approval, it only had indications for rheumatoid arthritis. In May 2021, it additionally secured efficacy and effectiveness for atopic dermatitis and in March of last year for severe alopecia areata in adults aged 18 and older. Before the Olumiant approval, there have been no other treatments with an indication for alopecia areata. Olumiant’s post-marketing survey (PMS) period has been adjusted to 6 years plus 35 months due to expansion in additional indication. As a result, PMS will end on November 10, 2026. Meanwhile, Pfizer’s 'Xeljanz (tofacitinib),' Lily’s 'Olumiant (baricitinib),' AbbVie’s 'Rinvoq (upadacitinib)' and Pfizer’s 'Cibinqo (abrocitinib)' are competing in the domestic market for JAK. According to a medical market research firm UBIST, last year’s outpatient prescription sales for JAK were KRW 13.7 billion for Olumiant, KRW 13.3 billion for Xeljanz, and KRW 12.4 billion for Rinvoq, with Olumiant having the highest sales.
- Policy
- Multiple sclerosis drug Ocrevusis approved in Korea
- by Lee, Hye-Kyung May 14, 2024 05:48am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced on the 13th that it has approved Roche Korea’s orphan drug Ocrevus (ocrelizumab) for multiple sclerosis (MS) in Korea. Multiple sclerosis is a chronic condition that develops in the central nervous system, which consists of the brain, spinal cord, and optic nerves and is an autoimmune disease in which the patient's immune system attacks the body’s healthy cells and tissues. Ocrevus Inj is a recombinant humanized monoclonal antibody (mAb, IgG1) that selectively targets CD20-expressing B cells, reducing the number and function of B cells to inhibit MS. The initial dose is 600 mg divided into 2 intravenous infusions, followed by a single 600 mg intravenous infusion every 6 months. Ocrevus was approved by the US FDA in March 2017 for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis. At the time of its initial approval, Ocrevus was approved for twice-yearly dosing following 2 two-week induction therapies. The drug was then additionally approved in December 2020 to reduce the dosing time to 2 hours from 3.5 hours. Ocrevus is the top-selling drug for multiple sclerosis, posting sales of USD 6.27 billion (KRW 8 trillion) in 2020. The MFDS said, "We expect this drug to provide a new treatment opportunity for patients with relapsing-remitting and primary progressive MS. We will continue to do our best to ensure that treatments with sufficiently verified safety and effect are promptly supplied based on our regulatory science expertise.”
- Policy
- BIO KOREA 2024 concludes a success
- by Lee, Hye-Kyung May 14, 2024 05:48am
- BIO KOREA 2024, cohosted by the Korea Health Industry Development Institute (President: Soon-do Cha) and the Provincial Administration of Chungcheongbuk-do (Governer: Young-hwan Kim), concluded successfully on the 10th. BIO KOREA 2024, which celebrates its 19th anniversary this year, was held for 3 days at COEX in Seoul under the theme of 'The Future of Biotechnology Innovation and Global Collaboration. Pic of BIO KOREA 2024 event At the event, participants shared the trends and prospects of innovative technologies that have recently attracted attention in the biohealth industry. The event also provided opportunities for global companies, institutions, researchers, and investors needed for the successful development of these technologies to forge business partnerships. 55 countries, 707 companies, and over 30,000 people attended the event. In a congratulatory speech at the opening ceremony, Minister of Health and Welfare Kyoo-HongChosaid, "We will continue to expand R&D support, create a mega fund, support exports, and foster specialized talent for the goal of making the leap and becoming a global biohealth hub. We expect BIO KOREA to spark cooperation for open innovation for Korean innovative businesses with innovative technologies of the future generation to expand their presence in the global market.” The event included business partnering, investment fair, exhibition, and conference programs. In the business partnering program, which had been expanded due to increased demand for meetings following the participation of leading domestic and international biohealth companies, more than 1,800 meetings were held over 3 days to explore various business opportunities such as finding new partners, discussing technology cooperation and joint research, technology transfer, and investment. The number of overseas participants attending to discover excellent domestic technologies increased by about 25% from the previous year, and the number of meetings held increased by about 36% in the same period. The number of overseas companies participating in the exhibition increased by 37% , and 81 local companies from 10 countries participated in the National Pavilion and actively discussed business opportunities with domestic companies. The conference featured 11 sessions that introduced and shared the latest advances and technology trends in the biohealth industry, including next-generation drug discovery platforms, diabetes and obesity treatments, microbiomes, and global open innovation. The conference hall was filled with attendees showing great interest in the special sessions on next-generation drug discovery platforms, diabetes and obesity drugs that are gaining explosive interest and demand, and AI new drug development. KHIDI President Soon-Do Cha remarked, “Thanks to the interest and active participation of domestic and international companies, organizations, and stakeholders, the BIO KOREA 2024 has concluded smoothly. We hope that BIO KOREA will continue to serve as the largest technology and business exchange venue in Korea where Korean companies can forge global partnerships and create new business opportunities."
- Policy
- New dementia drug Leqembi’s approval imminent in Korea
- by Lee, Hye-Kyung May 14, 2024 05:48am
- The marketing authorization for Leqembi (lecanemab), the first drug to slow the progression of Alzheimer's disease, is imminent in Korea. According to industry sources on the 14th, the Ministry of Food and Drug Safety (MFDS) completed the safety and efficacy review of ‘Leqembi (lecanemab),’ a new drug for Alzheimer's disease that was co-developed by the Japan-based Eisai and US-based Biogen. The safety and efficacy review is the final step in Korea’s approval process, and as long as there are no serious issues during the review, the drug is granted marketing authorization. If the drug’s official approval is announced in Korea soon, Korea will become the 4th country in the world to approve Leqembi, following the United States (July 2023), Japan (September 2023), and China (January 2024). Currently, ‘donepezil,’ ‘galantamine,’ ‘rivastigmine,’ and ‘memantine' are used to treat dementia, including Alzheimer's disease, but all are only able to relieve symptoms such as cognitive impairment and do not fundamentally slow the progression of dementia. Therefore, a dire need existed for a new drug that fundamentally delays dementia by removing abnormal 'amyloid' and 'tau', which are known to be the cause of Alzheimer's disease. After Eisai and Biogen’s Aduhelm (aducanumab) received conditional approval in June 2021, Leqembi received FDA approval last year, opening up the possibility of a new treatment market for Alzheimer's. In the Clarity-AD study, Leqembi was shown to delay cognitive decline by 27% after 18 months of treatment in 1,795 patients, with a 0.45 point less change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) compared to placebo. Based on these results, if and when Leqembi is approved, its indication in Korea, is expected to be for the ‘treatment of mild cognitive impairment due to Alzheimer's disease and early Alzheimer's disease’ like by the FDA. Leqembiis administered to patients as an intravenous infusion once every two weeks. Leqembi has been proven to reduce the rate of disease progression and slow cognitive decline by selectively binding to amyloid beta (Aβ) aggregates, which are a known cause of Alzheimer's disease. However, in the case of amyloid-targeted therapies, amyloid-related imaging abnormalities(ARIA), which are abnormal signals such as brain edema or microhemorrhage observed on MRI scans, may occur with their use. Although the first new Alzheimer's drug is expected to be commercialized in Korea, the biggest obstacle to its use is its drug cost. Leqembi costs about KRW35 million per year in the U.S. and KRW 27 million in Japan. Since this means it would cost tens of millions of won to slow down the progression of mild dementia, Korean patients are forced to wait for it to be covered by insurance. Even if a new drug is eventually introduced, it will take a lot of time, including drug pricing negotiations, before it can be used by patients. Meanwhile, companies in Korea are also steadily developing Alzheimer's drugs. According to the 'Development of Diagnosis and Treatment for Alzheimer's Disease Report’ that was published by KoreaBIO in 2022, GemVax & Kael, CHA Biotech, AriBio, D&D Pharmatech, ABL Bio, Oscotecc are currently developing new drugs for dementia. Recently, Dong-A ST received approval to conduct a Phase 1 clinical trial for 'DA-7503', an Alzheimer's treatment that inhibits tau aggregation. However, many potential Alzheimer's drugs have failed to overcome the barrier of clinical trials. In 2007, Kwang Dong Pharmaceutical advanced its natural product dementia drug ‘KD501’ to Phase II clinical trials, but in 2019, it put the development on hold. CHA Biotech also conducted a domestic Phase 1/2a clinical trial of its stem cell therapy-based Alzheimer's drug ‘PlaSTEM-AD’ in 2019, but no news has been heard of its results.
- Policy
- SGLT-2 monotherapy 'Suglat' set to withdraw from KOR
- by Lee, Tak-Sun May 13, 2024 05:51am
- Astellas Korea The SGLT-2 inhibitor 'Suglat tab 50 mg (Ipragliflozin L-Proline),' which is used as monotherapy, will no longer be available in the market in South Korea. Three SGLT-2 monotherapies that were imported will be withdrawn from the Korean market, as Steglatro and Forxiga are set to be withdrawn. According to the Ministry of Food and Drug Safety (MFDS) on April 10th, Astellas Korea has reported that the company will stop distributing Suglat as of August 15th due to a business decision. Astellas explained, “We have confirmed that there are enough alternative agents available for the treatment of patients. Therefore, the likelihood of a supply shortage for the treatment of type 2 diabetes is likely low.” The company added that additional measures or plans after they stop distribution are unnecessary. Suglat is a diabetes treatment that was co-developed by Japan’s Astellas and Kotobuki Pharmaceutical. It was launched in Korea in 2015. Handok was previously responsible for co-distribution with Astellas, following Daewoong Pharmaceutical. Three SGLT-2 monotherapy items are to be withdrawn from the Korea market. Last year, AstraZeneca decided to stop distributing Forxiga (dapagliflozin propanediol) in the second half of this year and recently cancelled the product approval. MSD Korea reported to the MFDS in March that the company will distribute Steglatro Tab 5 mg (ertugliflozin L-pyroglutamic) until May. The decision was made due to decreased market demand. Suglat’s withdrawal from the Korean market appears to be due to below-expected sales, with outpatient prescription sales of KRW 4 billion, according to UBIST last year. The company may have determined that imported new drugs might not be able to compete against the release of Forxiga generics in April of last year. The remaining imported SGLT-2 monotherapy is Boehringer Ingelheim Korea’s Jardiance Tab (empagliflozin). SGLT-2 monotherapy developed in Korea is Daewoong Pharmaceutical’s 'Envlo tab (enavogliflozin),' launched last year. As imported new drugs are to be withdrawal, Envlo will have an opportunity to expand its share in the market. Boehringer Ingelheim aims expand the reimbursement of Jardiance to kidney disease treatment to fill the gap left by Forxiga. According to the report on the SGLT-2 monotherapy prescription performance by UBIST last year, Jardiance ranked first with KRW 58.1 billion, followed by Forxiga with KRW 55.5 billion, Suglat with KRW 4 billion, Envlo with KRW 3.7 billion, and Steglatro with KRW 11.1 billion. Attention is drawn to the impact of the withdrawal of three imported original items from the Korean market on future competition.
- Policy
- 'BIO KOREA 2024' begins
- by Lee, Hye-Kyung May 10, 2024 05:47am
- 'BIO KOREA 2024' will be held on May 8-May10 for three days at Coex, Seoul. The conference is co-organized by the Korea Health Industry Development Institute (President Soon-do Cha, referred to as KHIDI) and Chungcheongbuk-do Province (Mayor Young Hwan Kim, referred to as Chungbuk), and sponsored by the Ministry of Health and Welfare (MOHW). Celebrating its 19th convention this year, BIO KOREA started back in 2006 with the participation of 300 companies from 20 countries. The number of participants has more than doubled, and by 2024, it reached 600 companies from 50 countries. BIO KOREA became the international bio-health convention representing South Korea. The theme for BIO KOREA 2024 is "The Future of Biotechnology Innovation and Global Collaboration." The convention aims to share the latest trends and prospects of innovative technologies in the bio-health industry and provide opportunities for business collaboration among global companies, institutions, researchers, and investors. Various programs will be organized for three days, including Business Partnering, Invest Fair, Exhibition, and Conference. This year, 640 companies from 55 countries are participating. At Business Partnering, Korean and foreign companies, including global pharmaceutical companies, participate in one-on-one business meetings to discover new partners with promising technologies, discuss technology collaboration and joint research, technology transfer, and investment. Of note, Global companies, including Eli Lilly, Takeda, Merck, MSD (Sharp & Dohme), Sanofi, Roche, Boehringer Ingelheim, and Johnson & Johnson, and companies representing the biopharma industry in South Korea, such as SK Bioscience, ST Pharm, GC Corp, Yuhan, Hanmi Pharmaceutical, Handok, and Dong Wha Pharm, are participating. At Invest Fair, equity firms utilizing K-BIO mega funds and global investors will share the prospects of the bio-health industry in South Korea and present the industry’s potential for growth. Experts from various companies will participate in presentations and panel sessions. The participants include Johnson & Johnson Development Corporation’s Melinda Richter, ARCH Venture Partners’s Ari Nowacek, Teralys Capital’s Cedric Bisson, Kurma Partners’ Daniel Parera, Yuanta Asia Investment’s ChiaYen Lo Sam. A session focusing on the successful attraction of foreign investment cases by domestic bio-innovation startups is also planned. This session aims to enhance understanding of investment value and global collaboration in the Korean biotech industry and explore strategies for commercializing innovative technologies. This year, participation from national delegations has expanded compared to the previous year, with 81 companies from 10 countries, including Australia, Sweden, Denmark, the United Kingdom, the United States, and Germany, set to showcase their promising technologies and engage in exchanges with interested companies in South Korea. Thirty-eight companies from fields such as CDMO, CRO, and microbiome are participating at the Australian Embassy in Seoul booth. Additionally, at the Nordic booth jointly operated by the Swedish Trade and Invest Council and the Danish Embassy in Korea, 13 companies specializing in CRO, vaccines, and drug development are participating. In addition, local companies will participate at the booths of the British Embassy in Seoul, BioCom California in the United States, and the state of Bavaria in Germany to promote their outstanding technologies and engage in business exchanges with domestic companies. At the conference, 71 speakers from 9 countries who are experts in the bio-health industry in South Korea and foreign countries. Speakers will participate in 11 sessions discussing 10 topics, including Drug Discovery Platform, Diabetes-Obesity Treatment, Cancer Vaccine, and Global Open Innovation. On May 9th, a special session called 'New Drug Modality Development Strategies' will be held. In this session, speakers will share the latest strategies for the development of new modality drugs, such as Antibody-Drug Conjugate (ADC), Targeted Protein Degradation (TPD), and Cell and Gene Therapy (CGT). They will also discuss cases of global cooperation. The speakers for the session include Zheru Zhang of WuXiBiologics, Mikio Kasahara of Roche, and Dr. Ulf bethke of Miltenyi Biotec. Following the session, some Korean companies, such as PINOTBIO and AbTis, will give pitch talks. They will showcase promising technologies developed by these Korean companies and discuss development strategies. KHIDI’s President Soon-do Cha said, "We hope that BIO KOREA will provide the opportunity for the domestic and foreign companies, institutions, and researchers in the bio-health industry to converge and discuss business strategies and collaboration.” He added, “We also hope that outstanding technology developed in South Korea will enter the global market through global partnership.” More convention details are available on the BIO KOREA 2024 website (www.biokorea.org). Additionally, people who have not pre-registered but wish to attend the convention can still register at the registration booth set up at Coex during the convention.
- Policy
- Celltrion Pharm completes localizing 3 Edarbi products
- by Lee, Hye-Kyung May 09, 2024 05:52am
- Celltrion Pharm has completed the localization of Edarbi Tab (azilsartan medoxomil potassium), a treatment for essential hypertension. On the 8th, the Ministry of Food and Drug Safety (MFDS) simultaneously withdrew and approved the authorization of Celltrion Pharm's Edarbi Tab 20mg. In December 2020, Celltrion Pharm acquired the entire rights, including sales and patents, of Takeda Pharmaceuticals' 12 ETC and 6 OTC drugs in 9 countries in the Asia-Pacific region for USD 278.3 million (approximately KRW 307.4 billion). The Edarbi license that was withdrawn this time is the item Takeda Pharmaceuticals received approval for in May 2017 and then sold to Celltrion Pharm. Celltrion Pharm had previously received approval for its Edarbi 40 mg and 80 mg in December 2023 and then withdrew the licenses for the Edarbi Tab 40 and 80 mg that the company acquired from Takeda Pharmaceuticals in March 2024. With the simultaneous approval and withdrawal of Edarbi 20mg, the company completed preparations to localize the production of the hypertension treatment. Celltrion Pharm acquired all rights to Edarbi and has been preparing to self-produce and sell the drug to ensure stable product distribution. Edarbi is an angiotensin II receptor blocking (ARB) class drug used for the management and treatment of hypertension. The drug lowers blood pressure by blocking angiotensin II receptors and suppressing angiotensin II, a hormone that increases blood pressure. Adults may take 40 mg of Edarbi once daily, with or without food, and may increase the dose to a maximum of 80 mg per day if the patient’s blood pressure is not adequately controlled. Edarbi 20 mg is indicated as an initial dose for the very elderly (75 years or above) who are at risk for hypotension, patients with mild-to-moderate hepatic impairment, and patients with possible intravascular volume depletion. Following the launch of its alogliptin+metformin combination therapy for diabetes the past year, Celltrion Pharm has received approval for its Edarbi as ‘Celltrion Azilsartan Medoxomil Tablets’ for export and as ‘Edarbi Tab’ for domestic use.
- Policy
- Name of transferred and aquired drugs can be changed in KOR
- by Lee, Hye-Kyung May 09, 2024 05:52am
- Korea’s regulations now stipulate that brand names of a drug transferred to a different company can be changed. According to industry sources on the 7th, the Ministry of Food and Drug Safety recently announced the revision of the 'Casebook for Drug Product Naming Practices (Citizen's Guide)' and announced the allowance of brand name changes. The MFDS changed the regulation that only allowed the company name of a product to be changed upon transfer of a drug that was specified in 2016 to allow the product name to be changed as well. However, in response to inquiries from the pharmaceutical industry regarding the transferred drug’s product name, the MFDS has been responding that "the product name is determined after comprehensive consideration on its domestic use (including similar product names) at the time of completion of the marketing authorization (report).” The pharmaceutical industry had also inquired whether a pharmaceutical company that voluntarily withdraws its marketing authorization for the product and acquires a product with the same ingredient from a third party can apply for the grant to change the product name of the new item to the name previously held by the company. In general, in order to change the product name upon receiving approval for the change in manufactured and imported items (report) due to transfer or assignment, Article 10 (9) of ‘Regulation on Pharmaceuticals Approval, Notification, and Review’ allows for change of a product’s name if it meets the criteria of Article 10 (8) of the same regulation. If a company wishes to use the same product name as the withdrawn item, the company may change the product name to the other name if it is clear that the withdrawn item was not distributed in the market and lacks production and import performance within the period of use granted for the withdrawn item before the transfer. However, the authorities added that the situation at the time of marketing authorization would need to be considered. However, during the revision of the citizen’s guide, the MFDS has given a clear answer that "it is possible to use” the previous product’s name in the event of a product transfer (merger or acquisition, etc.). The MFDS may grant permission to a company to change the name of a product in accordance with Article 11, paragraph 2 of the 'Rules on the Safety of Medicines, etc.' if the product name the company seeks to use is in accordance with Article 11, paragraph 2 of the 'Rules on the Safety of Medicines, etc.’ Meanwhile, the MFDS also reviews the conformity of the product name change as part of the drug's labelling during marketing authorization reviews.
