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- 2026-05-04 18:09:02
- Policy
- National lot release for Moderna's bivalent COVID-19 vaccine
- by Lee, Hye-Kyung Oct 13, 2022 06:08am
- The 1.57 million courses of the bivalent vaccine manufactured by Samsung Biologics have been approved for national lot release. The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had approved the national lot release for 1.57 million courses of Moderna Korea’s domestically manufactured mRNA bivalent COVID-19 vaccine, ‘Spikevax 2’ on the 11th. The national lot release system was implemented to reaffirm the quality of a vaccine through a comprehensive evaluation of the state’s national test and the manufacture and test results of the manufacturer for each manufacturing unit (lot) before they are distributed on the market. Spikevax-2 is manufactured in Korea (by Samsung Biologics) through fill-finish processes after being supplied the API of the same Spikevax-2 vaccine that has been approved for import on September 8th from overseas. The MFDS expects the national lot release approval of the bivalent COVID-19 vaccine will contribute to the prevention of COVID-19 and will continue efforts to ensure a stable supply of quality vaccines through thorough and swift verification of COVID-19 vaccines to come.
- Policy
- The loss of health insurance is close to 200 billion won
- by Lee, Jeong-Hwan Oct 13, 2022 06:08am
- Rep. Nam In-soon said, "The Legislation and Judiciary Committee's pending bill to recover the reduction will be dealt with." Over the past decade, health insurance benefit losses amounted to 19.7 billion won for 17 cases in which pharmaceutical companies lost lawsuits related to weak cuts and re-evaluation. Critics point out that the revision of the Health Insurance Act, which calls for the recovery and refund system of drug prices, should be handled as soon as possible to prevent pharmaceutical companies from suing lawsuits to cancel drug prices. On the 6th, Rep. Nam In-soon of the Democratic Party of Korea said, "We should pass the National Assembly's Health and Welfare Committee and deal with the revision of the Health Insurance Act pending at the Legislation and Judiciary Committee as soon as possible to minimize the loss of health insurance finances and achieve pharmaceutical rights." Regarding the claim that some pharmaceutical companies are concerned that the regulation on redemption within the revision of the Health Insurance Act may neutralize the effect of suspension of execution, a principle of litigation law, Rep. Nam insisted that "it is not persuasive." Considering the ongoing administrative litigation of pharmaceutical companies, administrative trials, and applications for suspension of execution for the drug reduction, and accumulated financial losses on health insurance, she believes the National Assembly should wrap up the legislation as soon as possible. She said, "The provisions for the redemption and refund of the amendment do not limit the application for administrative litigation or suspension of execution itself." She emphasized, "It is a system operated on the premise of filing administrative litigation and administrative trial, and the purpose is to post-calculate losses incurred in the NHIS or pharmaceutical companies during the suspension period according to the characteristics of the profitable health insurance drug price system." Rep. Nam said, "If legality is recognized after the decision to suspend execution, it is similar to the purpose of the Supreme Court ruling in September 2020, which judged that the administration should take active measures the same as if there was no decision to suspend execution," adding, "It is expected to minimize health insurance financial losses and protect pharmaceutical companies' rights." "The loss of health insurance benefits for 17 cases lost by the plaintiff pharmaceutical company out of 49 administrative lawsuits is estimated to be 19.7 billion won, but the financial loss of health insurance due to the difference in drug prices before and after the decision to suspend execution of 49 administrative lawsuits," she added.
- Policy
- 99 items were granted generic exclusivity, none reimbursed
- by Lee, Tak-Sun Oct 12, 2022 05:50am
- ▲ Boehringer Ingelheim diabetes combo drug Although 99 items were granted generic exclusivity, none of the items were granted reimbursement during the period. This was what happened to generics of Boehringer Ingelheim’s Jardiance Duo (empagliflozin+metformin hcl). Although a large number of products were approved and even obtained generic exclusivity, the drugs were unsellable in the market, and the exclusive rights granted for the products became obsolete. According to industry sources on the 11th, the generic exclusivity granted to 99 Jardiance Duo generics ended on August 15th. However, none of the items were listed for reimbursement and sold in the market during the period. This was not unexpected. Although the Jardiance Duo generics succeeded in avoiding subsequent patents and obtained generic exclusivity, they were unable to release their drugs to the market due to a substance patent that was not registered with the Ministry of Food and Drug Safety. The MFDS patent list serves as the standard for granting generic exclusivity. A substance patent for the single ingredient Jardiance is currently listed, but none is listed for Jardiance Duo. Based on the patent list, companies that manufacture Jardiance Duo generics were allowed to release their drugs after approval as they have overcome all of the registered patents by avoiding subsequent patents that are terminated after the substance patent. Thus, all Jardiance Duo latecomers that were approved from November last year to April this year were allowed to be marketed upon approval under the drug approval-patent linkage system, and their generic exclusivity period was also set based on the approval date. The end date was set until August 15th based on the products that were approved in November last year. However, substance patents need to be observed due to the risk of a dispute with the patentee regardless of whether or not it is registered on the MFDS patent list. The substance patent for Jardiance Duo is set to expire on October 23rd, 2025. Ironically, the generic exclusivity of the single-ingredient Jardiance is set to start on October 24th, 2025. In other words, generics of the combination drug Jardiance Duo were unable to be sold in the market even with the generic exclusivity. Then how were 99 items allowed to receive this obsolete generic exclusivity? This is because the restrictions set for the 1+3 consigned bioequivalence tests were implemented in July last year. Pharmaceutical companies that conducted bioequivalence tests after July 2012 could only consign manufacture of same-ingredient drugs for up to 3 pharmaceutical companies. As a result, pharmaceutical companies had entered into consignment agreements before the enforcement of this law and rushed the development of their generics, which resulted in the manufacture of such large number of Jardiance Duo generics. According to the MFDS, Dongkoo Bio&Pharma is currently manufacturing empagliflozin+metformin hcl products on consignment for 24 pharmaceutical companies (71 items in total). Such large-scale consignment manufacture was possible because the generic was developed before the enforcement of the consigned bioequivalence test restriction law. As the approved items may only be sold after 4 years from now, it seems inevitable that all of the test products manufactured for approval will have to bd discarded. This means that much social cost was wasted due to the new regulations. Couldn't the generics rather be regulated through drug prices? The Ministry of Health and Welfare had announced a drug pricing system in July 2020, one year before the enforcement of the consigned bioequivalence test restriction law. The system focused on reinforcing the standard requirements for self-bioequivalence tests and a stepped drug pricing system. Under the new system, generics are required to conduct self-bioequivalence tests and be listed within the 20th in the reimbursement list to maintain its base price, which is 53.55% of the insurance ceiling price of the original drug. However, the system could be bypassed as many items that apply for reimbursement at the same time are listed at the same time and considered a single group, and not discounted their price even if the number exceeds 20. Jardiance Duo generics will also be able to avoid the stepped pricing system by applying for the insurance price at the same time before patent expiry. However, such waste from large-scale approvals will not be made for items that were developed after the bioequivalence restrictions were set last year, as only 4 companies at most will be approved at once.
- Policy
- Ponesimod's Domestic Item License
- by Lee, Hye-Kyung Oct 12, 2022 05:50am
- Ponesimod of Janssen Korea, a rare drug for treating multiple sclerosis, has been approved for domestic items. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 11th that it has approved Ponesimo for the treatment of recurrent dysplasia in adults. The drug has been shown to reduce inflammatory reactions by blocking lymphocytes from being separated from lymphatic organs and inducing the number of lymphocytes in peripheral blood to decrease rapidly. Ponesimo is expected to reduce the occurrence of new diseases in patients with multiple sclerosis and prevent additional disorders from occurring and accumulating due to repeated and continuous symptoms. Ponesimo was designated as a rare drug in Korea on October 1 last year after being approved by the U.S. FDA in March last year as a treatment for adult patients with recurrent multiple sclerosis, including clinical solitary syndrome, recurrence-relaxation disease, and active secondary progressive disease. The Ministry of Food and Drug Safety said, "We expect that this rare drug license will contribute to improving the quality of life of patients by expanding their treatment opportunities and options." The Ministry of Food and Drug Safety said, "We will do our best to expand treatment opportunities to patients such as rare and incurable diseases by quickly supplying treatments that have been sufficiently confirmed in safety and effectiveness based on regulatory science expertise."
- Policy
- Alvogen’s Alymsys reimbursed...compete with Avastin similar
- by Lee, Tak-Sun Oct 12, 2022 05:50am
- Samsung Bioepis’s Avastin biosimilar Competition for biosimilars of the anticancer drug Avastin (bevacizumab) is intensifying in the domestic market. Alvogen’s ‘Alymsys’ is making a bid against Samsung Bioepis’s ‘Onbevzi,' which had been dominating the Avastin biosimilar market. With the entry of Alymsys, the original Avastin and its two biosimilars will be competing in the market. According to industry sources on the 11th, Alvogen Korea’s ‘Alymsys inj.’ will be included on the NHI reimbursement list starting this month. The maximum reimbursement price for the 0.1g dose will be KRW 208,144 per vial, the same as Samsung Bioepis’s ‘Onbevzi inj.’ The price of the 0.4g dose was also set at KRW 677,471, the same as Onbevzi. The price of its original, Roche’s Avastin inj is set at KRW 218,782 for the 0.1g dose and KRW 712,098 for the 0.4g, which is slightly higher than its biosimilars. Onbevzi enjoyed a monopoly in the biosimilar market for 1 year after being approved for reimbursement in September last year, and enjoyed a significant preoccupation effect in the market. Its sales, which reached KRW 0.5 billion in Q4 last year based on IQVIA, had continued rising to KRW 1.8 billion in Q1, and then KRW 4.1 billion in Q2. At this rate, its sales is expected to exceed KRW 10 billion only one year since its launch. With the launch of Onbevzi, Avastin’s price was also discounted. With the price reduction, its sales also dropped by KRW 20 billion from the KRW 58.9 billion in 1H of the previous year to KRW 38.1 billion in the 1H this year. Avastin is a targeted therapy monoclonal antibody that is widely indicated for the treatment of various cancers including ▲metastatic colorectal cancer, ▲metastatic breast cancer ▲non-small-cell lung cancer ▲advanced or metastatic renal cell carcinoma, ▲glioblastoma, ▲epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, ▲uterine cervical cancer, etc. Its market size exceeds KRW 100 billion in Korea. Due to its potential, biosimilar companies that had mainly stayed abroad have been launching large-scale marketing activities in the Korean market. However, Avastin’s patent emerged as a variable. Due to the patent, biosimilars were restricted from being used like the original drug, in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin for the ovarian cancer indication. Samsung’s Onbevzi was also unable to obtain this indication due to unresolved patent issues earlier in its release. On the other hand, Alvogen’s Alymsys was approved with the said indication. This is why the release of Alymsys was expected to weaken the competitiveness of Onbevzi in the market. But the situation was once again reversed with Samsung reaching an agreement on patent issues with the original developer Genentech, and Alvogen failing to do so. Samsung recently reached an agreement with Genentech for the patent suit on Avastin, which had been ongoing since June 2020. As a result, the company was able to obtain an additional indication for epithelial ovarian cancer last month. Alvogen, on the other hand, had to delete the indication in August due to a patent dispute and received reimbursement approval for the remaining indications. This is why the reimbursement approval period was delayed by one month. Despite some indication-related issues, many experts expect biosimilars to succeed in the domestic market, considering the high usage rate of bevacizumab in various other cancers as well. Samsung Bioepis entrusted sales of its product to Boryung Pharmaceutical, which is showing prominence in the anticancer drug market, and Alvogen to the large domestic pharmaceutical company Daewoong Pharmaceuticals for its early settlement in the market. In addition, Celltrion also received approval for its ‘Vegzelma inj’ on September 28th and is working to release the drug with reimbursement within the year. Celltrion also reached an agreement on Avastin’s patent with Genetech in May and was approved for the same indication as the original, including ovarian cancer related indication. Until now, Remsima was the only product that showed a good performance in the domestic biosimilar market. It is analyzed that the domestic biosimilar market is also entering full-fledged growth, starting with the Avastin biosimilar.
- Policy
- Two companies' Ticagrelor can be reimbursed
- by Lee, Tak-Sun Oct 07, 2022 06:04am
- Brilinta was released last monthAs Kukje and Korea United Pharmaceutical newly entered the anti-thrombotic Ticagrelor market, it was reorganized into a competitive system for nine companies. Although the original Brilinta's material patent expired in November last year, only six pharmaceutical companies' products entered the market due to high manufacturing costs and lack of marketability. And although generics for exclusivity ended last August, no news of generics' benefit was heard that month. According to the industry on the 6th, Kukjel has obtained benefits for Ticagrelor since September and Korea United Pharmaceutical from this month. Kukje is competing in the market with Brilor and Korea United Pharmaceutical with Tiglor. Competition, which had been stagnant due to their participation, has resumed. Currently, Hutex Pharmaceutical Korea, Alboven Korea, Hana Pharmaceutical, Samjin Pharmaceutical, Korea United Pharmaceutical, Kukjel, Genuonesciences, and Chong Kun Dang are competing in the market. Among them, Samjin, Korea United Pharm, Kukje Pharma, Genuonescience, and Chong Kun Dang are their own manufactured products, and the rest of the products are all entrusted to Genuonescience for consignment production. There are 41 licensed generics for Ticagrelor companies, but many consigned items are believed to have given up the market due to high raw material prices. Kukje and United Pharm, which have additionally been challenged, are analyzed to have solved the cost problem through their manufacturing. However, it is not a good situation for generic companies to succeed in the market. First of all, the Ticagrelor formulation market is gradually decreasing. Original Brilinta's outpatient prescription performance is gradually decreasing, with 10.8 billion won in 2019, 9.8 billion won in 2020 and 9.7 billion won in 2021. United is also seeking to expand its market by adding Tiglor to Clopidogrel-based Clavixin and Clavixin Duo. In the medical field, Ticagrelor does not have drug resistance due to existing clopidogrel CYP2C19 gene mutation It is believed that generics can sufficiently succeed in the market because it has the advantage of fast drug expression time.
- Policy
- Innovative pharmaceutical companies' new drug tx
- by Lee, Jeong-Hwan Oct 07, 2022 06:03am
- It was also pointed out that the government is delaying the preparation of a sub-law of a clause that favors the price of new drugs developed by innovative pharmaceutical companies in the Special Act on the Promotion of the Pharmaceutical Industry. Critics say that it has not been active in subsequent legislation such as enforcement ordinances and enforcement rules for the fourth year of legislation. On the 5th, Rep. Nam In-soon of the Democratic Party of Korea claimed, "We need to come up with a policy of preferential treatment for new drugs made by innovative pharmaceutical companies as soon as possible." Nam is criticizing the government for being indifferent to follow-up legislation even though the law on the addition of the upper limit on health insurance medical care benefits was implemented in December 2018 for new innovative pharmaceutical companies unrelated to the Korea-U.S. FTA trade issue. In particular, considering that improving the self-sufficiency rate of raw materials is an important task, it was also suggested that it is necessary to consider preferential treatment for related raw materials such as infectious disease vaccines such as COVID-19 and innovative new drugs. Rep. Nam In-soon said, "The government has designated bio-health as the so-called Big3 industry and has been pushing for a plan to promote bio-digital health as a major export industry and improve public health by spreading digital healthcare and big data-based advanced and precision medical care." Representative Nam said, "There are only generic drug preferential regulations for innovative pharmaceutical companies, but there are no drug preferential regulations for new drugs, so the contradictory situation of encouraging generic development over new drugs continues." She then said, "We are also implementing a policy that favors drug prices for the first approved new drugs in Japan and Taiwan and new drugs from companies that have conducted clinical trials in Korea." She added, "To become a global hub of bio and digital health, not only support such as preferential drug prices for innovative pharmaceutical companies, but also various support measures such as training R&D and manpower, financial support, overseas expansion support, and reduction of levies."
- Policy
- The incidence of adverse effects in Alecensa is 80%
- by Lee, Hye-Kyung Oct 06, 2022 06:05am
- A five-year post-marketing survey (PMS) of the Anaplastic Lymphoma Kinase (ALK) mutant non-small cell lung cancer treatment Alecensa 150mg showed 1012 significant drug abnormalities that could not rule out causality. The permit will be changed with 20 and 122 cases of serious drug adverse reactions and unexpected drug adverse reactions that cannot be excluded from causal relationships, respectively. The Ministry of Food and Drug Safety announced that it will prepare an order (proposal) to change the permission based on the results of the investigation after marketing Alecensa in Roche Korea and conduct an opinion inquiry until the 19th. Eisai Korea obtained an item license for Fycompa film coated tab on July 10, 2015. Alecensa received a domestic item license in October 2016 for the treatment of ALK-positive local progressive and metastatic non-small cell lung cancer patients who had been treated with Xalkori. After expanding the indication to primary treatment in 2018, Alecensa sales exceeded Xalkori, which is 20.3 billion won, from 10.4 billion won in 2018 to 22.1 billion won in 2019. Since then, it has expanded to 29.3 billion won in 2020 and 32.7 billion won in 2021. As a result of a five-year post-marketing survey of 345 people under the patient registration program in Korea, the expression rate of abnormal cases was reported to be 80.29% (277/345 cases, a total of 1012 cases), regardless of causality. Among them, 4.64% (16/345 people, 20 cases) of serious drug abnormalities were reported, including mouth inflammation, increased blood bilirubin, increased blood creatine phosphorylase, increased blood creatinine, peripheral edema, fever, and death. Unexpected drug abnormalities such as decreased red blood cell volume rate decreased red blood cell count, joint pain, muscle weakness, dizziness, and nephropathy were found to be 24.06% (83/345 cases, 122 cases). The Ministry of Food and Drug Safety plans to change the permit after hearing opinions on the change order.
- Policy
- MFDS prepares clinical trial guidelines for COVID-19 drugs
- by Lee, Hye-Kyung Oct 06, 2022 06:05am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) published and distributed the ‘Clinical trial guideline on antiviral treatments for mild-to-moderate COVID-19 infections’ to support the rapid development of COVID-19 antivirals by guiding companies on the new clinical outcome parameters and methods for designing flexible clinical trials. The guideline was prepared to promote the preparation of a rapid clinical support platform to support the development of COVID-19 vaccines and treatments, which was part of the 100 Tasks for Food and Drug Regulatory Innovation that the MFDS had announced on August 11th. The guideline contains the additional new clinical outcome parameters required for clinical trials on mild-to-moderate COVID-19 patients and includes considerations that need to be made in selecting subjects, clinical treatment effect evaluation methods, efficacy evaluation, and in designing and performing clinical trials. The existing clinical outcome parameter was effective in preventing severe COVID-19, however, due to the decrease in severe COVID-19 patients, this parameter had made it difficult to perform clinical trials. Therefore, a new indicator had to be inevitably set in line with the COVID-19 situation, which is why the government added symptom improvement as a new parameter. The MFDS said, “the addition of the new clinical outcome parameter will aid rapid development of treatments by enabling easier progress of clinical trials, including faster recruitment of clinical trial subjects. We have improved the predictability and transparency of the trials by allowing companies to introduce an adaptive design in preparing clinical trial protocols so the number of test subjects can be appropriately changed based on the results of the interim analysis.” Also, if the company has received approval for a clinical trial plan in advance, the trial can be conducted without additional approval, which is also expected to help reduce the period. As the trial is conducted on infectious patients, the guideline also guides companies on the major considerations that require attention when conducting non-face-to-face clinical trials and case studies. More information can be accessed on the MFDS website (www.mfds.go.kr) > Legislative data > Resources > Guide/Guidelines.
- Policy
- Data for reevaluation to be submitted from the 24th
- by Lee, Tak-Sun Oct 05, 2022 06:11am
- The data submission system for reevaluation of listed drugs that was set to be operated as of the 1st of this month will be operated from the 24th. The authorities plan to receive data submitted before then through the Health Insurance Review and Assessment Service’s e-mail. With the data submission system not being initiated in time, the industry has repeatedly been pointing to the administration's lack of preparation. Voices are continuing to rise in the industry to postpone the reevaluation of listed drugs in consideration of the circumstances, including the COVID-19 situation. According to the industry on the 3rd, HIRA has been notifying through associations that the data submission system for reevaluation of listed drugs that was set to be serviced from the 1st will be serviced from the 24th. Data submission is important to prove as the drugs subject to evaluations need to meet the reevaluation requirements or receive discounted ceiling prices depending on their degree of satisfaction. The health authorities have been requiring companies to submit data proving that the standard requirements were met to HIRA from the 1st of this month to February 28th next year. The standard requirements that need to be submitted are self-bioequivalence test data or evidence of clinical trial performance; and documents proving the use of APIs registered in the Drug Master File (DMF). If the subject drug satisfies both requirements, the ceiling price is maintained as is; however, if the drug satisfies only one of the two requirements, the price is reduced to 85%, and to 72.25% if both requirements are not met. As most listed drugs satisfy the DMF requirement, the self-bioequivalence test data will become the determining factor for the price discounts. The Ministry of Health and Welfare first applied the requirements to drugs that were newly listed from July 2020, and provide a grace period of 3 years for previously listed drugs. Therefore, the price adjustments for the listed drugs are planned on July 2023. To meet the self-bioequivalence test requirement, companies have switched their consigned products to in-house production and conducted self-bioequivalence tests. However, the COVID-19 outbreak in 2020 rendered the progress of the tests difficult, raising the suggestion that the entire revaluation schedule should be postponed. However, the MOHW decided to conduct the reevaluation of listed drugs as scheduled with some exceptions, with the goal of making price adjustments in July next year at the Health Insurance Policy Deliberative Committee meeting that was held on the 29th. However, the Ministry of Food and Drug Safety extended the data submission deadline for some oral preparations and sterile preparations among prescription drugs that were designated and subject to bioequivalence tests by 5 months, and the reports will be accepted if they are submitted by the end of May. Data on all other items will have to be submitted to HIRA by February 28th next year, as initially scheduled. Data submissions started on October 1st, but the authorities will have to wait another 20 days before the electronic window opens. Of course, the companies may submit their data via e-mail, but complaints about the delay in the industry are fierce as they are already pressed for schedule. An industry official said, “The government seems to not be ready to conduct the reviews that they have hurried the companies to prepare. With the 20-day delay in the data submission system, I wonder whether HIRA will be able to complete the review within the set period for the NHIS to complete pricing negotiations.
