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- 2025-12-21 23:26:06
- Policy
- Daewoong also enter the Vemlidy late-stage drug market
- by Lee, Tak-Sun Feb 23, 2023 05:46am
- Gilead’s hepatitis B treatment Daewoong Pharmaceutical and Chong Kun Dang will also enter the late-stage drug market for Vemlidy, a chronic hepatitis B treatment previously occupied by Dong-A ST. Daewoong and Chong Kun Dang's products received a month's delay in obtaining approvals, and their benefits were also applied a month later. According to the industry on the 20th, from March 1, Daewoong Pharmaceutical's Vemlidy and Chong Kun Dang's Tenofobell-A will be covered. The two products are salt-modifying drugs of Gilead Sciences' 'Vemlidy'. Daewoong Vemlidy has Tenofovir Alafenamide HemiFumarate as the main ingredient, and Chong Kun Dang Tenofobell-A has Tenofovir Alafenamide Succinate as the main ingredient. These products succeed in the patent challenge through salt change, obtain generics for exclusivity, and are released before generics when the patent has not expired. The drug price calculation standard for salt-changing drugs is 90% of the original. Daewoong Vemliver costs 2828 won, which is 80% of the original Vemlidy (3,535 won). Chong Kun Dang Tenofobell-A costs 2,439 won, which is 69% of the original price. This amount is cheaper than Donga ST Vemlia's 2,474 won, which was previously applied for benefits. Each generic has a different drug pricing strategy, and it is noteworthy how it will affect market sales. Meanwhile, Jeil Pharm's 'Tecavir-D', which was licensed in the same month as Daewoong's and Chong Kun Dang's, is not on the March reimbursement list. Vemlidy is an upgraded version of Gilead's existing hepatitis B treatment 'Viread'. The patent is scheduled to expire on August 15, 2032, and a generic drug with the same ingredient will have to wait another nine years. Last year, Vemlidy's outpatient prescriptions (based on UBIST) were 47.1 billion won, up 18% YoY.
- Policy
- 9 bepotastine besilate antihistamines listed for reimb
- by Lee, Tak-Sun Feb 23, 2023 05:46am
- Leading bepotastine besilate product Sustained-release antihistamine drugs that contain bepotastine besilate will be listed for reimbursement for the first time in Korea. The original bepotastine besilate product developed by Mitsubishi Tanabe Pharma Corporation is Tarion. Tarion was sold by Dong-A ST in 2004 in Korea, and the company withdrew from the Korean market in December 2017 after the drug’s patent expired. Therefore, only its generics that contain the same ingredients and salt-modified products are currently being sold in the Korean market. According to industry sources on the 21st, 9 sustained-release antihistamine products will be listed for reimbursement at a ceiling price of KRW 326 from March 1st. Companies that own related products are the CMO Dongkoo Bio&Pharma, and Mother’s Pharmaceutical, Eden Pharma, Yungjin Pharm, Kukje Pharma, Shin Poong Pharm, Hutecs Korea Pharmaceutical, Myungmoon Pharm, and Union Korea Pharm. This is the first time a sustained-release product that contains bepotastine besilate was listed, and currently ninety-two 10mg bepotastine besilate is taken twice a day, and one once-daily 5mg product is available in the market. Currently, the ceiling price for all the 10mg products is KRW 148 per tablet. By daily dose, the 10mg short-acting drugs cost KRW 296, which is cheaper than the sustained-release drugs, which cost KRW 326. In addition to bepotastine besilate, bepotastine salicylate products that contain a different salt is also available. Also, there are sustained-release products available for bepotastine salicylate. 5 short-acting products and 6 sustained-release products are available each. The ceiling price for these drugs is also KRW 148 for the short-acting product and KRW 326 for the sustained-release products. However, bepotastine besilate products have been showing better performance. Among the major items, Dong-A ST’s Twolion sold the most, recording KRW 9.5 billion in outpatient prescriptions (UBIST), followed by the KRW 4.6 billion made by Daewon Pharmaceutical’s Bepostarbi, then KRW 3.2 billion by Dong Kook’s Bepotan. Among the three products, Twolion and Bepostarbi are bepotastine besilate products and Bepotan is a bepotastine salicylate product. Although the salt-modified sustained-release tablets did not perform so well in the market until now, as sustained-release tablets that contain the same ingredient as the original were released, attention is being paid to whether they will break the existing market structure and drive the market. Antihistamines work as antagonists to excess histamine caused by antigen-antibody reactions and is used for allergic conditions and early cold treatment. In the early days of COVID-19, the market size shrank with the decline in the number of respiratory patients, but last year, it was also used for COVID-19 patients, which led to an upward trend. However, it is difficult for individual companies to develop their products into blockbusters. Competition is fierce in the market with over 100 generics and salt-modified products, and there are several second- and third-generation antihistamines including bepotastine, therefore, it is not easy to foster one product. However, even if the drugs cannot become a blockbuster, the drugs show performance continuously, therefore, industry officials expect the sustained release products can also successfully settle in the market, with sales and marketing activities.
- Policy
- SGLT-2 DM Combi Benefit Expansion Expected to be applied
- by Lee, Tak-Sun Feb 23, 2023 05:45am
- Expansion of reimbursement for the combination of SGLT-2 diabetes treatment and other treatments is expected to be applied from April. It is said that the government accepted the wage increase after receiving details of voluntary reductions from related companies earlier this month. According to the industry on the 20th, it was reported that the Ministry of Health and Welfare, which is discussing the expansion of the combined benefit of SGLT-2 diabetes treatment, has set up a plan to apply for the benefit in April. Currently, the concomitant benefit drugs being discussed are triple therapy such as metformin + SGLT-2 + DPP-4, metformin + SGLT-2 + TZD, and some SGLT-2 items + sulfonylurea or insulin combination therapy. The Ministry of Health and Welfare estimates that these combined benefits will cost tens of billions of won. The Ministry of Health and Welfare induced 11 companies with benefits expansion drugs to voluntarily lower the maximum amount in order to share finances as it requires enormous financial resources. However, in November of last year, the government received a voluntary cut rate and started an analysis of the fiscal impact, but there was no further progress as it exceeded the expected range. As a result, by the beginning of this month, the voluntary reduction rate was once again received, but this time it is interpreted that the financial range was satisfied. It is said that the companies have expanded the reduction rate and submitted it to the Ministry of Health and Welfare. For drugs that are voluntarily reduced to expand the range of use, benefits can be applied quickly because only a quality supply contract is required with the NHIS, bypassing the review by the Drug Evaluation Committee of the HIRA. In response, the government is said to be planning to apply for benefits from April through a report to the deliberation committee next month. As related combination drugs are currently waiting for approval, it is expected that the expansion of the combination benefit will become a new trend in the diabetes treatment market.
- Policy
- The ruling party promotes the establishment of a serious dz
- by Lee, Jeong-Hwan Feb 22, 2023 05:54am
- In order to strengthen health insurance coverage for anticancer drugs and treatments for severe rare diseases, legislation will be promoted to separately establish "severe disease accounting." On the 20th, Rep. Lee Jong-sung of the People's Power proposed a partial amendment to the National Health Insurance Act. Rep. Lee Jong-sung argued that health insurance coverage for treatments for severe and rare diseases has been reduced over the past five years of the Moon Jae In government. Lee explained that President Yoon Suk Yeol pledged to expand the application of health insurance for treatments for severe and rare diseases and adopted "relaxing the burden of high-priced medical expenses, such as the rapid registration of treatments for severe and rare diseases." Lee included a clause in the bill to establish a separate accounting for severe diseases for the benefit of treatments directly related to the lives of severely ill people in the health insurance finance. It is a method of using the finances saved by the re-evaluation of drug benefit adequacy and the risk-sharing system (RSA) as financial resources for accounting for severe diseases. Specifically, provisions such as grounds for the establishment and operation of accounting for serious diseases and financial resources for accounting for serious diseases were included. He said, "It is a plan to cover the necessary funds for the treatment of severe diseases without additional financial investment. Since the inauguration of the Yoon administration, expensive anticancer drugs and rare disease drugs have improved the lives of severely ill patients, but they are still suffering from double burdens of disease and economic burden. He added, "If the law is revised, the blind spot of the current medical expense support system for severely ill patients will be partially resolved."
- Policy
- Lucentis biosimilar Ameliebou prices cut 24.5% voluntarily
- by Kim, Jung-Ju Feb 22, 2023 05:54am
- Samsung Bioepis lowers the insurance drug price of its sixth biosimilar Ameliebou 10 mg/mL (Ranibizumab) by nearly 25%. It's been two months since the benefit was released. AbbVie Skyrizi PFS and Amgen Korea Repatha are used a lot, so they will conduct PVA with the NHIS and reduce drug prices to 3-6%. According to the industry on the 20th, the Ministry of Health and Welfare plans to revise the list of drug benefits and the upper limit and is pushing to apply it as of the 1st of next month. First of all, there are a total of six drugs that companies will voluntarily cut next month. Samsung Bioepis' biosimilar Ameliebou 10mg/mL will lower its price by 24.5% within two months of its launch. This drug is a biosimilar of Lucentis and is used to inhibit the formation of new blood vessels by binding to Vascular Endothelial Generating Factor (VEGF)-A. Samsung Bioepis signed a domestic distribution and sales contract with Samil Pharmaceutical with the launch of the product and launched it in January. In addition, products containing 20 mg and 10 mg of Yungjin Fluoxetine Cap will be lowered by 53.4% and 38.4%, respectively, while products containing Revlimid's generic, Lenaldo 10 mg and 5 mg of Kwangdong Pharmaceutical will be lowered by 21.1% and 21.2%, respectively. A total of two drugs will be reduced to PVA next month, subject to type "Ka" and "Na", respectively. If looking at the product, AbbVie Skyrizi PFS belongs to the type "Ga" and is on the negotiating list, agreeing to a 6.1% cut. Amgen Korea Repatha PFS will be lowered by 3.7% from next month as a result of PVA negotiations with the corporation.
- Policy
- Chong Kun Dang's Tamivir is listed as the lowest price
- by Lee, Tak-Sun Feb 22, 2023 05:54am
- Chong Kun Dang, which has stopped selling the flu treatment "Tamiflu" since this year, was immediately covered by the salary of its generic drug. Chong Kun Dang has been selling Tamiflu for more than a decade in partnership with Roche Korea since 2012 and has not released its own generics with only permission. According to the industry on the 20th, Tamivir 30, 45, and 75mg per Chong Kun Dang will be listed as salary at 524, 907 won, and 1063 won, respectively. Tamivir was approved in December 2009 and was the earliest Korean generic to be approved. Chong Kun Dang has been unable to come to the market since 2012 because it has sold the original Tamiflu capsule in partnership with Roche Korea. Instead, Chong Kun Dang has been selling suspension powder products that are not in the original under the Tamivir brand. At the beginning of the year, Chong Kun Dang sent an official letter to the distribution industry and officially announced the suspension of Tamiflu sales, saying that the salesperson of 75, 45, and 30mg of Tamiflu capsules had been changed from Chong Kun Dang to Roche Korea as of January 6. As a result, the registration of Tamivir is interpreted as a measure following the suspension of sales of Tamiflu by Chong Kun Dang. The Tamivir capsule is currently the lowest price on the same system. In the case of Oseltamivir capsule 30mg, the highest price is 854 won and the lowest price is 790 won, which is 266-330 won more expensive than Chong Kun Dang Tamivir products. 45 mg and 75 mg also differ in price from Chong Kun Dang products. Analysts say that Chong Kun Dang is likely to settle in the market for a short period of time as it has experience in selling Tamiflu and has price competitiveness. As COVID-19 subsides, the flu is on the rise again, and some predict that it could exceed the expected sales in March without supply issues. Attention is focused on how much sales Chong Kun Dang, which changed its product from original to generic, will make in the market.
- Policy
- Revlimid generics also allowed reimb for MDS
- by Lee, Tak-Sun Feb 22, 2023 05:54am
- Boryung’s lenalidomide drug Generic versions of Revlimid Cap that contain the same ingredients will be applied reimbursement for the treatment of myelodysplastic syndrome (MDS) in Korea. This is because the generic versions also obtained approval for the indication in October last year. On the 21st, the Health Insurance Review and Assessment Service preannounced plans to apply the above changes when making amendments to the ‘Notices required according to drugs prescribed and administered to cancer patients.’ The amendment will take effect on March 1. The previous reimbursement standards only allowed reimbursement for the original drug, ‘Revlimid Cap,’ among lenalidomide drugs as a treatment for MDS. The standards had been applied since May 2019. Such a decision was made in consideration of the fact that the indications for the same-ingredient drugs that were approved by the MFDS. In the past, only Revlimid had indications related to MDS syndrome approved by the MFDS. However, its generics – Boryung Pharma’s Leblikin Cap, Kwang-dong Pharm’s Lenaldo Cap, and Samyang Holding’s Lenalid Tab – also gained approval for the indication in October last year. This is why HIRA is amending the standards to apply reimbursement to generics as well. Therefore, patients who receive treatment for MDS within the approved indication and reimbursement standards will be granted reimbursement. Meanwhile, the standards for reimbursement of hematopoietic stem cell transplantation will also be amended to allow reimbursement for hematopoietic stem cell transplantations that were conducted without the prior approval process to be allowed reimbursement if they submit other evidentiary that that is equivalent to prior approvals. For this, the notes on the use of blinatumomab monotherapy (Note 6) and inotuzumab ozogamicin monotherapy (note 8) will be changed for acute lymphoblastic leukemia.
- Policy
- Plan to build an information network to normalize the supply
- by Lee, Hye-Kyung Feb 22, 2023 05:54am
- “External environmental factors such as the spread of COVID-19 and the war between Ukraine and Russia have made domestic drug supply and demand abnormal. On January 15, Korea Rare Essential Medicines Center appointed Kim Jin-seok (58, Kyungsung University College of Medicine), former deputy director of the Ministry of Food and Drug Safety, as the 13th director. The KODC, which was established to provide various information on orphan drugs and national essential drugs, is currently managing 511 items of national essential drugs and 315 cases of orphan and essential drugs submitted to the on-site supply and demand monitoring center. A total of 179 items and 14,732 drugs were supplied by the KODC last year, worth 44.2 billion won. Nine free support programs that connect pharmaceutical companies and patients are also in operation, through which 969 new drugs in clinical trials were supplied. Director Kim met with reporters from the Ministry of Food and Drug Safety on the 21st and revealed his ambition to be appointed director of the KODC after 8 months of vacancy. The following is a Q&A from Director Kim. ▶ As the director was appointed after 8 months of vacancy, it seems that there was a setback in the project. "There was a long hiatus for eight months after the former director's resignation. During this period, there was a shortage of medicines around the world due to the outbreak of COVID-19 and monkeypox. Korea was no exception, and monitoring of essential national medicines and supply shortages of medicines occurred. We are aware of the need for a domestic supply of drugs, so this year we plan to focus our efforts on the stable supply of national essential medicines. As in the case of last year’s case where the center urgently imported from Australia to solve the domestic shortage of antipyretics and analgesics due to COVID-19, domestic We will develop our capacity so that the center can play a big role in the stable supply of medicines.” ▶ Please explain the promotion project in a little more detail. “As revealed in the name of the center, the primary goal is to supply medicines that have lost their market function, such as orphan drugs and national essential medicines, from state institutions. Whether it is an orphan drug, an essential drug, or a drug with usage monitoring, a situation in which supply and demand arise means that the function of the market appears in an abnormal situation. It depends on whether or not, but for orphan drugs, at least a network is built with data on suppliers and countries. This year, it plans to build an information network for essential medicines and medicines that require on-site supply and demand monitoring. The Ministry of Food and Drug Safety signed a contract for a consignment project to build an information network last week. Internally, a program is being developed to increase the accuracy of usage statistics for essential medicines. We will complete it within this year so that production and usage can be predicted based on statistical data. " ▶ Recently, there have been cases of drug price adjustments due to shortages, and we know that orphan essential drugs have the biggest concern about profitability. Are there separate studies in this regard? “Because the center is a non-profit corporation under the Ministry of Food and Drug Safety and does not operate a profit-making business, there is no need to adjust the price of medicines supplied by the center due to a shortage of medicines. There was a case that this center that had an impact on the drug price. Last year, the drug price of 'Natasin Eye Suspension' was adjusted due to the increase in the unit price of medicine." ▶Please explain the on-site drug supply and demand monitoring project. “The center is operating an on-site supply and demand monitoring center with 7 professional organizations, including the Korea Hospital Pharmacists Association, the Korean Medical Association, the Korean Pharmaceutical Association, the Korea Pharmaceutical and Biopharmaceutical Association, the Global Pharmaceutical Industry Association, the Korea Biopharmaceutical Association, and the Korea Pharmaceutical Distribution Association. Each organization When a request for medicines in need of supply is made through expert consultation, supply-related issues are informed and solutions are sought.” ▶The budget for the center increased from 3.3 billion won last year to 4.6 billion won this year. How will the increased budget be used? “The main items of the center’s increased budget this year are 490 million won for consignment manufacturing and 600 million won for office relocation, and isoproterenol hydrochloride injection will be introduced as a new consignment manufacturing item to address the need for a stable supply of medicines that have been continuously raised.” We plan to move the center to the Post Tower adjacent to Myeongdong Station in June. The building located along the main road will make it more convenient for users of the center." ▶At the plenary meeting of the Health and Welfare Committee of the National Assembly held on the 9th, it was pointed out that it is necessary to secure personnel exclusively responsible for monitoring the supply and demand situation of medicines in the Korea Rare Essential Drug Center and to establish a close cooperation system with medical and pharmaceutical organizations. "This year, we plan to strengthen the monitoring of discontinued medicines through the administrative network linked to the Ministry of Food and Drug Safety by further activating the operation of the on-site drug supply and demand monitoring network. In particular, actively promote two-way communication between supply and demand monitoring networks through real-time information sharing with 7 specialized organizations Through this, we intend to strengthen the monitoring of unstable supply together.”
- Policy
- Severe Cancer Drug Benefits, covered by the National Budget
- by Lee, Jeong-Hwan Feb 20, 2023 05:53am
- The legislation will be promoted in which the state is responsible for the cost of applying health insurance benefits for new drugs for the treatment of severe diseases and cancer. It also included a provision to include a new technology support project for cancer treatment in the scope of the National Health Insurance Service's work and to raise the funding rate used for new technologies for cancer treatment. On the 14th, Kang Sun-woo, a member of the Democratic Party of Korea, announced that he proposed three amendments to the Cancer Management Act, the National Health Insurance Act, and the National Health Promotion Act. Lawmaker Kang plans to name the three package bills proposed this time as the "Three Acts of State Responsibility for Severe Diseases" and push for legislation. The current law stipulates that cancer treatment and medical expenses should be subsidized according to income level to ease the economic burden of severely ill patients and cancer patients. However, it has been pointed out that in the current medical expenses support system, the limit of support is limited. Cancer patients are in financial difficulties and lose their lives due to the lack of rapid health insurance benefits after the approval of the Ministry of Food and Drug Safety. In response, Kang proposed a new support project to support new non-paid cancer treatment and new medical technology from the budget of the National Health Promotion Fund and included new cancer treatment technology support projects within the scope of the National Health Insurance Corporation's work. It also specified legal grounds for raising the National Health Insurance Service fund support rate (partial amendment to the National Health Promotion Act) used for related support projects such as new cancer treatment technologies. Lawmaker Kang said, "We proposed the bill in the sense that strengthening the coverage of drugs for severe diseases directly related to the lives of the people should be carried out more actively with government support."
- Policy
- The Minister's willingness to innovate regulations
- by Lee, Hye-Kyung Feb 20, 2023 05:53am
- A full view of Hanmi Pharmaceutical Oh Yoo-kyung, head of the Ministry of Food and Drug Safety, met with representatives of pharmaceutical companies and expressed his willingness to innovate regulations. At 2 p.m. today (15th), Director Oh met with representatives of pharmaceutical industries such as Hanmi Pharmaceutical, Dasan Pharmaceutical, Daewoong Pharmaceutical, Amgen Korea, Inist, Pfizer Korea, Huons, and Hugel at the Hanmi Pharmaceutical Research Center. The meeting was held in the name of the New Year's meeting, and the reason why Hanmi Pharmaceutical Research Center was selected as a venue is to encourage executives and employees of Hanmi Pharmaceutical, which has been approved for marketing by the U.S. FDA, for the first time in Korea. In September last year, Hanmi Pharmaceutical received FDA approval for the treatment of neutropenia, "Rolontis." "We are grateful for the hard work of the company officials who are striving to develop the domestic pharmaceutical industry and improve their international status," Oh said. "The Ministry of Food and Drug Safety will also do its best to improve the drug system and provide administrative support." It announced its plan to boldly change Korean drug regulations to global standards so that domestic companies can enter and compete in overseas markets. "The Ministry of Food and Drug Safety will work closely with the industry and related organizations to promote regulatory innovation so that Korean drug regulations can lead the international standards," Oh said. "Please continue to develop high-quality new drugs to open new treatment opportunities for our people." The meeting was held to introduce major policy directions and core brand businesses of the Ministry of Food and Drug Safety in 2023 and to discuss future development and regulatory innovation measures of the Ministry of Food and Drug Safety with related industry officials. The Global Leader, Partner, Supporter (GPS) project was introduced as a major policy in the pharmaceutical sector, which means accelerating entry into the international market through global leadership to strengthen export support, partners in pharmaceutical production using advanced digital technology, and customized support for global innovative products. The Ministry of Food and Drug Safety plans to support the virtuous cycle of the pharmaceutical industry by enhancing Korea's international status and becoming a leading regulatory country through international harmonization of pharmaceutical regulations. Previously, it operated a Global Innovative Products on Fast Track (GIFT) program to help global innovative medical products become quickly commercialized and dominate the global market. It said it would implement customized regulatory support projects to quickly enter the next-generation biopharmaceutical market. The plan is to establish a preemptive item classification system for new concept drugs as the development of new concept products that transcends the classification and concept of existing drugs is expanded. If a biopharmaceutical company applies for and discovers next-generation biopharmaceuticals, it will support regulations through internal communication, classification standards, customized regulatory support, internal review committee, external consultation, notification and objection, procedures, and information provision. To secure vaccine sovereignty, it also announced plans to operate a national cell bank, test and analysis of vaccines at an international level, comprehensive technology consulting from vaccine development to licensing, overseas licensing strategy consulting, and expand the foundation for future-oriented policy and system development. The Ministry of Food and Drug Safety said it will continue to play the role of a regulatory agency that protects public safety based on regulatory science expertise, push for export GPS strategies to enter the global market beyond global technical regulations, and play a role as a partner in organically communicating and cooperating with industries and organizations.
