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- 2026-04-29 05:11:03
- Policy
- KDCA 'COVID-19 drug supply will be stabilized within August'
- by Lee, Hye-Kyung Aug 16, 2024 05:55am
- The government has explained that pharmacies nationwide will have enough COVID-19 drugs by the last week of August. In the case of self-test kits, the government added that it plans to produce and supply more than 5 million kits within August to ensure no shortage. The Ministry of Health and Welfare (Minister Kyoo-hong Cho) held a joint meeting with the Korea Disease Control and Prevention Agency (KDCA) (Commissioner Young-mee Jee), the Office of the Government Policy Coordination (Minister Ki-sun Bang), the Ministry of Education (Minister Ju-ho Lee), the Ministry of Interior and Safety (Minister Sang-min Lee), Ministry of Food and Drug Safety (Director Yu-Kyoung Oh), and the National Fire Agency (Commissioner Seok-gon Heo) met together on the 14th at 4:30 p.m. to review Korea’s ‘COVID-19 epidemic trend and countermeasures’ in light of the recent increase in COVID-19 infections. The weekly usage of COVID-19 treatments as disclosed by the KDCA increased to exceed 42,000 doses in the 5th week of July, compared to the 1,272 doses used in the 4th week of July, exceeding the amount used during the summer season last year. To address the increased usage, the KDCA plans to supply additional drugs sequentially from this week, so that there will be enough drugs in all pharmacies that supply COVID-19 treatments from the last week of August (8.25~8.31). “We will endeavor to ensure smooth access to the treatment everywhere in the country by the last week of August,” the KDCA said. The Ministry of Health and Welfare plans to promptly review COVID-19 treatments that apply for reimbursement upon approval by the Ministry of Food and Drug Safety by hastening the reimbursement adequacy evaluation, NHIS negotiations, and Health Insurance Policy Review Committee deliberations. The MFDS is closely monitoring the supply of COVID-19 self-test kits and the entire production and distribution process. Domestic manufacturers have been scaling back production of self-test kits since COVID-19 turned endemic, but have recently expanded their production and supply to meet the rise in demand for COVID-19 test kits since late July. Korea’s COVID-19 self-test kit manufacturers own sufficient facilities, technology, and capacity to meet domestic demand, and are expected to produce and supply more than 5 million self-test kits within August. The MFDS added, “Korea’s COVID-19 self-test kit manufacturers have produced 40 million self-test kits per week in the past.” Meanwhile, the number of hospitalized COVID-19 patients has been increasing again since the end of June, and the number of hospitalized patients reached its peak this year (1,357, provisional) in the second week of August. While respiratory viruses are primarily prevalent during the winter season, COVID-19 has also been prevalent during the summer season (July-August) in 2022 and 2023, and given this trend, the number of COVID-19 patients is expected to continue to increase in the near future. According to the Ministry of Health and Welfare, the number of emergency room visits due to COVID-19 jumped from 2,240 in June to 11,627 in July. The MOHW said, “We plan to establish a cooperative system for hospitalization of COVID-19 patients by securing free beds, mainly in public hospitals that had been previously operated as dedicated COVID-19 hub hospitals. In order to ensure prompt treatment of COVID-19 patients in their local areas according to the pandemic situation, we plan to secure a list of COVID-19 treatment hospitals by local governments in cooperation with the Ministry of the Interior and Safety and local governments, and publish it through the Emergency Medical Services System.” The 2024-2025 COVID-19 vaccination plan will utilize a new vaccine (against the JN.1 strain) that is more effective against strains currently circulating in Korea and around the world. The government is currently in the process of licensing and approving the new vaccine so that it can be administered simultaneously with the flu vaccine in October, and details of the plan will be announced in September. “To respond to the COVID-19 pandemic, we will work with relevant ministries and organizations to secure beds so that COVID-19 patients can be treated promptly, and expedite the procurement of COVId-19 treatments and their reimbursement listing so that high-risk patients can stably receive treatment,” said MOHW Minister Kyoo-hong Cho. “The fatality rate of COVID-19 in Korea in 2023 (January-August), after the Omicron variant outbreak, was in the 0.05% range, and less than 0.01% for those under 50 years old, so there is no need to be overly anxious about the outbreak this summer,” said KDCA Commissioner Young-mee Jee. ”We will do our best to ensure that the additional supplies of COVID-19 drugs we secure from next week be supplied smoothly to patients for their convenient use.”
- Policy
- Gov’t raises service fee for difficult surgeries
- by Lee, Tak-Sun Aug 14, 2024 05:51am
- The government is promoting a plan to completely reform the unbalanced structure of Korea’s fee-for-service system. For this, the government is reviewing whether to raise the compensation level for severe surgeries and reforming the relative value system and conversion index used to calculate medical service fees. Kyung-sil Jeong, Head of the Healthcare Reform Promotion Team at MOHW explained so at a briefing on the progress of Korea’s healthcare reform on the 13th. "Korea's reimbursement system is based on a 'fee-for-service system' that sets a unit price for every individual act of service," Jeong said, pointing out that "among the types of services, basic medical treatment, surgery, and treatment have lower fee levels, while testing, imaging, and functional type services have higher fee levels." The system has constantly been criticized as it incentivizes more tests than serious, high-risk surgeries. "We are promoting an overall reform to increase the compensation level in low-compensated areas and decrease the compensation level in high-compensated areas," Jeong said, adding, "First of all, we are considering raising the compensation level of about 1,000 severe surgeries, which are mainly performed at tertiary hospitals and general hospitals but have low fees." The government has established a 'Medical Cost Analysis Committee' within the Health Insurance Policy Review Committee to establish a system where medical fees can be quickly adjusted based on scientific evidence. The committee is also looking to reform the relative value system and conversion index, which are the basis of the fee-for-service system. "The committee has identified 6 priority areas that require concentrated investment: severe disease treatment, difficult essential medical treatment, emergency treatment, night and holiday treatment, pediatrics and childbirth, and vulnerable regions," Jeong said, adding, "In consideration of these priorities, we plan to more systemically introduce the public policy fee.” Furthermore, the government plans to transform the fee-for-service system into a "value-based payment system" to fundamentally improve the problem of how the current fee-for-service system increases the volume of procedures rather than improves the outcome of treatment. "The current system, which applies a uniform 15% premium to the reimbursement rate for services provided at tertiary general hospitals without distinguishing between severe and mild cases, will be converted to a system in which hospitals will be rewarded more for treating severe cases and less for treating mild cases," said Jeong, adding, "To this end, we will select and apply ‘appropriate disease groups' that are suited to the functions of each medical institution." Discussions are also underway to reform the management of non-reimbursed items and indemnity insurance. In July, the government formed a non-reimbursement and indemnity insurance subcommittee within the Specialized Committee for Essential Healthcare and Fair Compensation under the Special Committee on Healthcare Reform to discuss non-reimbursed management and indemnity insurance reform. During subcommittee discussions, it was suggested that non-reimbursed items with obvious excessive use concerns, such as manual therapy, cataract surgery with non-reimbursed lenses, and non-valve reconstruction, should be restricted, and that a management system should be established using the current positive listing system to set standard prices for non-reimbursed items that bring concerns over excessive use based on the non-reimbursed item status monitoring result and continuously manage the items through data analysis and re-evaluation. Regarding the reform of indemnity insurance, the role of the indemnity insurance as a complement to health insurance should be clarified and the system should be improved in line with this principle. During subcommittee discussions, an opinion was raised that the statutory coinsurance rate of the national health insurance should be adjusted to a reasonable level to minimize some of the negative impacts of indemnity insurance on the healthcare delivery system and access to healthcare. In particular, Jeong explained that there were suggestions that the scope of non-reimbursed coverage should be rationalized in conjunction with the government’s non-reimbursed item management measures to improve the issue of insufficient examination and follow-up due to the nature of indemnity insurance, where an agreement is made only between the insurer and the patient, and to reinforce the review and management system for proper use and supply of healthcare, "In order for the healthcare reform to succeed, we need to change the way people use healthcare, different to what they have been accustomed to," Jeong said, adding, "If you have relatively minor symptoms, please refrain from visiting emergency rooms of tertiary hospitals to make room for severe and urgent patients."
- Policy
- Coinsurance rate for chronic diseases reduced from 30%→20%
- by Lee, Hye-Kyung Aug 14, 2024 05:51am
- #1 The coinsurance rate for outpatient treatment at neighborhood clinics for chronic diseases such as hypertension and diabetes will be reduced by 10%, from 30% to 20%. The Ministry of Health and Welfare announced on the 13th that a partial amendment to the ‘Enforcement Decree of the National Health Insurance Act’ was approved at a cabinet meeting. The amendment includes the legal ground for a 10% reduction (from 30% to 20%) in the coinsurance rate for outpatient visits to clinics for chronic patients who meet the requirements notified by the Minister of Health and Welfare, such as applying for integrated management services for hypertension and diabetes and establishing and establishing and receiving review for customized management plans. The co-payment reduction system will be implemented from August 21st. The Ministry of Health and Welfare said that the amendment is expected to contribute to improving health by preventing complications, improving the healthcare delivery system, and encouraging rational use of healthcare by encouraging chronically ill patients to receive comprehensive and continuous management at neighborhood clinics. In addition to improving the coinsurance rate system for chronic diseases at the clinic level, the amendment also includes an exemption from reporting the total remuneration to the National Health Insurance Service if users submit a simplified withholding tax statement. Starting with the year-end settlement in 2025 (attributable to 2024), employers will be able to submit a simplified withholding tax statement (earned income) to the tax authorities, which will allow year-end settlement of insurance premiums through data linkage with the National Tax Service without reporting the total remuneration amount to the NHIS, which is expected to reduce the workload of employers. However, users should be aware that if they have not submitted a simplified withholding tax statement to the tax authorities, or if there is an error such as an omission of information on the simplified withholding tax statement, they will need to report the total remuneration amount of the previous year as they currently do. Also, to revitalize the monthly income adjustment system, the government has expanded the number of income brackets eligible for adjustment from 2 to 6 and made it possible to apply for adjustment not only if your income has decreased from the previous year, but also if it has increased. If a subscriber has temporarily earned more income than the previous year, he or she will be charged a higher premium next year, but from January 1, 2025, he or she will have the option to pay the higher premium in the year he or she earned the income through the monthly income adjustment process. The 2024 out-of-pocket maximum for the bottom 30% of the income bracket (income quintiles 1-3) will remain the same as last year to relieve the burden of out-of-pocket costs for medical expenses for lower-income subscribers. Also, to prevent social hospitalization in long-term care hospitals, the out-of-pocket maximum for nursing hospital stays of more than 120 days will be increased by the previous year's consumer price index (3.6%) for all quintiles (1st-10th), including those that fall in the bottom 30% of the income bracket. "The amendments to the Enforcement Decree are a follow-up to the 2nd Comprehensive National Health Insurance Plan announced in February," said Joong-gyu Lee, Director of the Bureau of Health Insurance Policy at the Ministry of Health and Welfare. "By unifying the year-end tax settlement report and expanding the scope of income monthly adjustment applications, these amendments will improve the convenience of insurance premium payments and contribute to easing the burden of medical expenses for chronically ill and low-income subscribers who receive comprehensive care."
- Policy
- Reimb for Paxlovid still pending amid COVID-19 resurgence
- by Lee, Tak-Sun Aug 12, 2024 05:55am
- Product photo of Paxlovid. As the COVID-19 treatment supply becomes an ongoing issue amid a virus resurgence, clinical practices are frustrated by delayed reimbursement coverage of 'Paxlovid (nirmatrelvir‧ritonavir, Pfizer Korea).' The drug reimbursement application for Paxlovid was submitted to the Health Insurance Review and Assessment Service (HIRA) in early October of last year. After that, HIRA has yet to finish the evaluation. On August 8th, Paxlovid was not considered for HIRA's Drug Reimbursement Evaluation Committee (DREC) review. Initially, Pfizer aimed to acquire reimbursement for Paxlovid for the first half of the year, but it has yet to be considered for the DREC review 10 months after submission. During this period, Pfizer submitted response letters to HIRA six times. The company recently requested HIRA an extended response letter due date. While the reimbursement for Paxlovid is being delayed, the Korean Disease Control and Prevention Agency (KDCPA) discontinued the free-of-charge program in May. Now, patients are required to pay KRW 50,000, which is approximately 5% of the drug price, for the drug. However, it is still provided free of charge for medical reimbursement benefit recipients and those eligible for co-payment reduction due to having the second-lowest income. When the drug became available for co-payment, some clinical practices prescribed Paxlovid to adult patients under different conditions. The basis for Paxlovid approval in South Korea is its efficacy and effectiveness in treating adults with mild to moderate symptoms who are at a high risk of developing severe COVID-19, including hospitalization and death. As a result, prescribing it to adults with mild symptoms still meets the efficacy and effectiveness criteria. However, when the government provided Paxlovid free of charge, it was only used for patients who were senior-aged and had severe symptoms. It seems that when the drug became available for co-payment, clinical practices mistakenly thought it had reimbursement criteria and prescribed it as approved. Recently, the Korea Disease Control and Prevention Agency (KDCPA) officially requested that clinical practices prescribe oral COVID-19 medicines, including Paxlovid, only to high-risk patients who show symptoms. Those who can be prescribed are patients over 60 years old and 12 years old (Paxlovid) or 18 years old and older (Lagevrio) who are immune compromised or with underlying diseases. Additionally, it must prescribed within 5 days of showing symptoms and for patients not needing oxygen therapy. The KDCPA said, "There are no changes to who can be prescribed COVID-19 medicines before or after issuing co-payment in May." They explained, "It can only be prescribed in clinical practices designated for COVID-19 medicines prescription." To prevent such confusion, some have pointed out the necessity of prescription criteria through reimbursement coverage, as well as agreements with pharmaceutical companies for the efficient supply of drugs. A HIRA official said, "Paxlovid will be internally evaluated soon and considered for the DREC review."
- Policy
- 4th PVA negotiations complete for Prolia
- by Lee, Tak-Sun Aug 08, 2024 09:25am
- The government completed price-volume agreement (PVA) negotiations for Prolia Prefilled Syringe (denosumab), the leading product in the domestic osteoporosis treatment market, with Amgen Korea. Whether the drug’s price will be adjusted for the 4th time under the PVA is gaining attention. According to industry sources on the 4th, Amgen Korea and the National Health Insurance Service recently agreed on PVA negotiation terms for Prolia. The current upper insurance price for Prolia is KRW 156,100. Prolia is a biological drug that targets the RANKL protein, which forms osteoclasts that destroy the bone. The drug is co-marketed by Amgen Korea and Chong Kun Dang in Korea. Ever since the drug was granted reimbursement in October 2017, the drug immediately dominated the domestic osteoporosis drug market. In April 2019, the drug was granted extended reimbursement, covering its use as a first-line therapy, which rapidly increased its use. According to IQVIA, Prolia’s domestic sales in Q1 amounted to KRW 41.2 billion, ranking second among all drugs. With sales rising steadily, the company inevitably had to negotiate Prolia’s price under the price-volume agreement system. Prolia's price has already been adjusted 3 times through negotiations. The first was a "Type A" negotiation in December 2020, which resulted in a 6.5% reduction. Type A negotiations are applied when the drug’s expected use amount increases by over 30%. The second was a "Type B" negotiation that was applied in August 2022. Type B negotiations are applied when the expected use amount increased by 60% or more compared to the previous year or increased by 10% or more but the total amount exceeds KRW 5 billion. The third was also a ‘Type B’ negotiation, which resulted in a 3.7% price cut in Prolia’s insurance price ceiling in August last year. If the drug price is adjusted this time, it will be the 4th PVA price reduction. In May, Prolia's insurance price ceiling was lowered from KRW 162,600 to KRW 156,100 due to the reimbursement extension. Prior to the reimbursement extension, patients with a bone mineral density measurement of -2.5 (T-score) or less were eligible for 1 year of benefits, but after the reimbursement extension, patients with a T-score of -2.0 or less and to -.2.5 are eligible for up to 2 years of reimbursement.
- Policy
- Topiramate XR generics may be released soon
- by Lee, Tak-Sun Aug 08, 2024 09:24am
- 국내 유일 토피라메이트 서방캡슐 Generic companies have applied for approval of new follow-on drugs of 'Qudexy XR Cap,’ an extended-release topiramate formulation used for epilepsy, to the Ministry of Food and Drug Safety. The follow-on drugs that applied for approval this time are film-coated tablet formulations rather than capsule formulations, and whether the generic companies will be able to avoid Qudexy’s patent with the changed formulation is gaining attention. According to industry sources on the 5th, 2 products with the same ingredient (topiramate) as 'Qudexy XR Cap have recently applied for approval to the MFDS. The MFDS notified the original company upon the generic companies’ application because the original company has a patent (extended-release topiramate capsules) registered on the list in accordance with the approval-patent linkage system. Generic companies have also applied for approval of their Qudexy XR Cap generics in December last year and in May this year. The industry is looking at Introbiopharma as the likely developer of a follow-on Qudexy XR Cap. This is because Introbiopharma conducted a bioequivalence test for its Topimed XR tablet (tentative name) with Qudexy XR Cap as a control drug. Qudexy XR Cap, which is supplied by SK Chemicals in Korea, is the first extended-release topiramate formulation in Korea. While the existing immediate-release topiramate formulation is taken twice a day, the extended-release formulation is absorbed slowly into the body and can be taken once a day, improving the patients’ convenience in administration. The drug was developed by the U.S. pharmaceutical company Upsher-Smith Laboratories and approved by the FDA in 2014. In Korea, it was approved by the Ministry of Food and Drug Safety in August 2017. Qudexy XR Cap is indicated to treat epilepsy ▲as monotherapy for the treatment of partial-onset seizures with or without secondary generalized seizures in children and adults 6 years of age and older; ▲partial-onset seizures, primary generalized tonic-clonic/convulsive seizures, and seizures associated with Lennox-Gastaut Syndrome with or without secondary generalized seizures in children and adults 2 years of age and older that are not adequately controlled by existing first-line antiepileptic drugs. The drug had been granted reimbursement since February 2018. Last year, outpatient prescriptions amounted to KRW 3.5 billion based on UBIST. As a single item, its sales are not very high. However, topiramate-based formulations account for KRW 30 billion of the KRW 80 billion antiepileptic drug market and are the most prescribed ingredient. This is why analysts saw high potential for the XR formulation. This explains the rapid move among generic companies to develop extended-release formulations. The patent for Qudexy XR Cap, which is registered on the MFDS Green List, is expected to last until January 2034. The patent covers the extended-release topiramate capsule. As the generic companies applied for film-coated topiramate tablet formulations, it is analyzed that the generics will likely be released to the market apart from the registered patent. "The patent currently registered for Qudexy XR Cap protects the capsule form, but the follow-on extended-release formulations the generic companies applied for are film-coated tablet formulations, so companies will likely be able to avoid the patent," said a pharmaceutical industry insider. "It seems that the generic companies have adopted a patent avoidance strategy to quickly develop their respective products.”
- Policy
- Price-Volume Agreement negotiations to be finalized soon
- by Lee, Tak-Sun Aug 08, 2024 09:24am
- The ‘Type C’ price-volume agreement (PVA) negotiations are expected to be completed next week. When the negotiations are complete, the insurance price ceiling of the subject items is expected to be adjusted from September after passing the Health Insurance Policy Review Committee review this month. According to the industry sources on the 6th, negotiations for the PVA ‘Type C’ items started in July and are expected to be finalized next week. The negotiations involved 60 product groups that contain identical ingredients. The Type C negotiation is conducted for drugs that do not fall under 'Type A' or 'Type B', which are negotiated upon listing, and whose claims for the same product group from the 4th year of listing have increased by more than 60% from the claims of the previous year, or by more than 10% but exceeds KRW 50 billion. Most Type C drugs are generic drugs that have received a set price upon listing. The National Health Insurance Service conducts Type C negotiations every year with the goal of adjusting the insurance price ceiling of subject drugs by September of the same year. During this year's negotiations, in particular, the pharmaceutical companies enjoyed increased options due to the amendment made to the details of the operating standards. For example, drugs whose usage has temporarily increased due to inevitable reasons such as the COVID-19 pandemic can choose to refund part of their claims instead of lowering the price. In the first round of negotiations that were given the option, several companies reportedly opted for the refund option. In addition, innovative pharmaceutical companies or companies with an R&D ratio of 10% or more, which have been subject to PVA negotiations 3 times within 5 years, will be eligible for a 30% less price reduction than the amount calculated via the reference formula rate in its third time. Although small, there are reportedly a small number of companies that have agreed to negotiate their price using this option. The pharmaceutical industry had previously expressed concerns to the government on how drugs that have completed bioequivalence tests for the price ceiling reevaluations may be subject to larger price cuts during PVA negotiations. The logic is that the price difference between a drug that has maintained its price through bioequivalence testing and the weighted average price of the same-ingredient drug becomes larger than the weighted average price of drugs with the same ingredient, resulting in a larger price reduction during PVA negotiations. In response, the pharmaceutical industry requested price adjustments for drugs that underwent bioequivalence tests for a prior reevaluation, considering how the companies have followed government policy. In response, the NHIS is said to have partially accepted the industry's opinion and reflected it qualitatively during negotiations. As a result, it is observed that all the negotiations will be completed within the deadline this year. "We understand that the negotiations will be completed by next week," said an industry official, "and the results will be announced after being reported to the HIPDC this month."
- Policy
- Approval of abortion drugs at a halt in KOR
- by Lee, Jeong-Hwan Jul 31, 2024 05:52am
- The Ministry of Food and Drug Safety has gained attention for stating that the Criminal Code and the Mother and Child Health Act must be amended before the approval of abortion drugs in Korea. The process of gaining marketing authorization for abortion drugs that the pharmaceutical companies applied for has been at a halt for 4 years, as follow-up legislation has not been enacted since the constitutionality of abortion was ruled unconstitutional. On the 29th, the Ministry of Food and Drug Safety responded so to a point raised by Representative Sun-min Kim of the National Assembly's Health and Welfare Committee regarding the domestic approval of abortion drugs. Kim raised the need for expedited approval of abortion drugs, questioning why the abortion drug has not yet been approved despite repeated applications submitted in 2021 and 2023. Hyundai Pharm applied for the marketing authorization of Mifegymiso in 2021 after signing an exclusive marketing and distribution agreement for its supply in Korea with the UK-based Linepharma International. However, the company voluntarily withdrew its application upon the MFDS’s data supplement request. The company then reapplied for the license last year (2023) and received another data supplementation request. Mifegymiso is a combination pack that contains 1 200mg mifepristone tablet and 4 misoprostol 200ug tablets. The drug inhibits the action of progesterone, the progestational hormone that sustains pregnancy, while misoprostol works to contract the uterus. It is only indicated for use in the first trimester of pregnancy, up to 9 weeks, and is typically prescribed as one tablet of mifepristone followed by 4 tablets of misoprostol 36-49 hours later. The MFDS’s position is that the Criminal Code and the Mother and Child Health Act must be amended before Mifegymiso, which the company has reapplied for approval, can be approved in Korea. The logic is that the abortion period should be established first so that a risk management plan can be submitted for the approval of abortion drugs like Mifegymiso. "Currently, there are permit data that can only be submitted after the amendment of the Criminal Code and the Mother and Child Health Act, which is why the review process has been temporarily suspended upon mutual recognition of the applicant and the MFDS,” said an MFDS official. "If the relevant laws are amended and the applicant submits data accordingly, we plan to resume the review without delay and decide whether to approve or reject the application.” Meanwhile, when the amendments will be made to the Criminal Code and Mother and Child Health Act remains unclear. In April 2019, the Constitutional Court ruled the criminal offense of abortion (termination of pregnancy) unconstitutional, citing respect for women's right to bodily self-determination. As of January 1, 2021, abortion was effectively legalized. The Constitutional Court ordered the National Assembly to come up with alternative legislation to reflect the decision, but 4 years have passed without such legislation being enacted. In the 21st National Assembly, 7 bills to abolish the abortion law were introduced, including amendments to the Criminal Code and the Mother and Child Health Act, but were never properly discussed until the end of the 21st NA period.
- Policy
- GSK receives administrative disposition in KOR
- by Lee, Hye-Kyung Jul 30, 2024 05:51am
- The global pharmaceutical company GlaxoSmithKline (GSK) has received administrative dispositions for failing to report changes to the specifications of the main ingredient of its active pharmaceutical ingredient and for issues relating to the drug containers. The Ministry of Food and Drug Safety recently imposed a fine of KRW 52.2 million in substitution of the 15-day suspension on the sale of ‘Duac Gel 5%,’ a 6-month import suspension on ‘Flixoteide Junior Evohaler 50 micrograms,’ and a 6-month import suspension on ‘Seretide 100-250-500 Diskus.’ Duac Gel is a gel-type mild-to-moderate treatment for acne that contains clindamycin phosphate and benzoyl peroxide. It is prescribed as an alternative that can alleviate concerns about the development of resistance that may arise from the use of antibiotics. However, an investigation by the MFDS found that the direct containers of the drug were imported and sold with the lot numbers and expiration dates switched with each other. As a result, the MFDS announced it will suspend the sales of Duac Gel 5% from August 1. Also, 1 item, which was suspended for six months, and 3 items, for which the company decided to pay fines instead of the suspension, were found to have failed to report changes in the specifications of the active pharmaceutical ingredient in the drug substance. The company will pay a fine of KRW 52.2 million for 3 items - Seretide 100 Diskus, Seretide 250 Diskus, and Seretide 500 Diskus - imposed in place of the 6-month suspension. Sales of Flixoteide Junior Evohaler 50 micrograms, a preventive treatment for asthma, are suspended for 6 months from August 1 to January 31, 2025.
- Policy
- Daewoong secures generic Xigduo through a transfer
- by Lee, Tak-Sun Jul 29, 2024 05:48am
- Daewoong Pharmaceutical has secured a generic version of the diabetes treatment Xigduo XR Tab (metformin hydrochloride/dapagliflozin propanediol hydrate) through a transfer and acquisition deal. The drug will be covered by reimbursement and introduced to the market in August. With the addition of generic Xigduo XR Tab, Daewoong Pharmaceutical now completes the product lineup, as its generic Forxiga 10 mg (dapagliflozin propanediol hydrate) is listed for reimbursement this month. According to industry sources on July 26th, Daewoong Pharmaceutical's Forxilomet XR Tab 10/1000mg, Forxilomet XR Tab 10/500mg, and Forxilomet XR Tab 5/500mg will be listed for reimbursement starting in August. These products' upper-limit prices are KRW 435, KRW 402, and KRW 342, respectively. Daewoong Pharmaceutical acquired these products already on the reimbursement listing through a transfer and acquisition deal. Daewoong Pharmaceutical acquired products from Jinyang Pharm and Huons. As a result, these products are manufactured by different contract manufacturing organization (CMO) sites. Kukje Pharm manufactures Forxilomet XR Tab 5/500mg and Forxilomet XR Tab 10/500mg, and Samik Pharmaceutical manufactures Forxilomet XR Tab 10/1000mg. Dongkoo Bio&Pharma manufactures Daewoong Pharmaceutical's monotherapy Forxilo tab 5mg and 10mg. Most pharmaceutical companies have listed their products immediately after the substance patent expiration on April 7th last year, but Daewoong Pharmaceutical was unable to do so. At the time, Daewoong was in a joint-sales agreement with the original company, AstraZeneca, to sell Forxiga and Xigduo. From 2018 to the end of last year, Daewoong Pharmaceutical was jointly selling Forxiga and Xigduo. As Forxiga is set to discontinue sales in South Korea, it was canceled for approval and deleted from the reimbursement listing. HK inno.N has been jointly selling Xigduo with AstraZeneca under a joint sales agreement since January. The ceiling price of Xigduo has been reduced by mandate since July 20th, after the introduction of generics. It was reduced after a year and three months after the generic entry. Although delayed, the price of Xigduo was reduced after AstraZeneca withdrew from filing a suit to cancel the mandatory reduction. Following a price reduction, sales reduction is inevitable. Therefore, AstraZeneca and HK inno.N as a team will likely put more effort into marketing. As a result, they are expected to compete fiercely against Daewoong Pharmaceutical. Although Boryung and Hanmi Pharm are now leading the generic market for dapagliflozin, Daewoong Pharmaceutical's entry will likely intensify competition among companies vying for the top spot. Companies aiming to dominate the market, including HK inno.N, which gained Forxiga's indication, are set to begin.
