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- 2025-12-22 00:01:33
- Policy
- [Reporter's view] Focus on non-face-to-face contraceptives
- by Lee, Jeong-Hwan Sep 14, 2023 06:37am
- The Ministry of Health and Welfare will hold a public hearing to prepare a reform plan for the non-face-to-face medical treatment pilot project from 2 p.m. today (14th). After disclosing the status of the pilot project, the plan is to hold a panel discussion to hear opinions from the medical community, pharmaceutical industry, platform app industry, and patient and consumer groups. The Ministry of Health and Welfare has not officially commented on the direction of the pilot project reform. Some media outlets only 'leaked' a statement that they are considering a reform plan to expand the scope of non-face-to-face first visitation. For this reason, some criticize that “the Ministry of Health and Welfare is busy using the media to gauge public opinion in order to expand the implementation of the non-face-to-face medical treatment pilot project.” Some even point out that rather than starting administration based on specific policy implementation grounds, they are belatedly formulating policies that suit their tastes after being conscious of public opinion. Non-face-to-face medical treatment is a policy that Minister of Health and Welfare Cho Gyu-hong and Second Vice Minister Park Min-soo have repeatedly emphasized over the years as to the need for institutionalization, but I wonder why they are so unsure about it. First of all, the Ministry of Health and Welfare plans to prepare a reform plan after holding a public hearing on the non-face-to-face medical treatment pilot project, but there are already media reports that there is a strong direction to expand the permitted time zone for the non-face-to-face first treatment to nights, late at nights and public holidays, and to expand the permitted area to areas with a shortage of medical institutions. The purpose is to enable residents in vulnerable areas who are not guaranteed access to medical care in the current pilot project to benefit from non-face-to-face medical treatment. There is some criticism of the direction of the Ministry of Health and Welfare's reorganization that it is trying to allow unlimited non-face-to-face first visits by modifying the 'time zone' regulations, but if evidence is presented that the truly unreasonable reality of pilot projects can be improved, there is some sympathy with the direction of the Ministry of Health and Welfare's reorganization. It can be expressed. This means that the Ministry of Health and Welfare should specifically present cases where non-face-to-face treatment is not available due to a lack of medical institutions nearby, even though the area is not remote, such as islands or mountainous regions. The Ministry of Health and Welfare has not made a single comment on how to manage the side effects that are concentrated in non-covered high-risk prescription drugs such as morning-after contraceptives, isotretinoin-based acne treatments, and finasteride-based hair loss treatments, which have been pointed out several times as representative side effects of non-face-to-face therapy. The Ministry of Health and Welfare only reiterated its position that it would discuss expanding the scope of prescription-restricted drugs through a pilot project advisory group meeting but did not present any measures or blueprints on how to manage the concentration of prescriptions for high-risk medications. Even after the implementation of the pilot project, non-face-to-face treatment prescription patterns or statistics are not disclosed. Due to this situation, pharmacist professional organizations such as the Seoul Pharmaceutical Association and the Korean Pharmaceutical Association are individually calculating and publicizing their own statistics. The justification for implementing and institutionalizing the non-face-to-face medical treatment pilot project announced by the Ministry of Health and Welfare is ‘strengthening medical access for medically vulnerable groups and residents.’ It is questionable whether the concentration of non-covered prescriptions for morning-after contraceptives, acne medicines, and hair loss medicines is in line with the Ministry of Health and Welfare's goal of strengthening the medical rights of the medically vulnerable. Even in this situation, the Ministry of Health and Welfare is considering improvement measures to expand the scope of initial and repeat visits for non-face-to-face medical treatment, and it is highly likely that the Ministry of Health and Welfare will continue to mention the need to expand the scope at the public hearing to be held today. The fact that the Ministry of Health and Welfare has not made any comments regarding regulatory measures for non-covered prescription drugs influenced Democratic Party lawmaker Jeon Hye-sook to come to the conclusion that she suspected 'collusion between platform operators and the government.' The National Assembly and medical groups have been calling for several years since the COVID-19 pandemic to address the side effects of unnecessary medications being excessively prescribed through non-face-to-face treatment and platforms, but the Ministry of Health and Welfare has not made any specific comments. Vice Minister Park Min-soo strongly opposed Rep. Jeon Hye-sook's point that the Ministry of Health and Welfare is pushing for non-face-to-face medical treatment to save the platform. Rather than protesting, the first priority is to create an alternative that can solve the problem of wasting health insurance funds through excessive treatment and overprescription and increasing the risk of side effects from medicines for patients. Platforms have gained too much power and have grown into 'super apps', standing over medical institutions and pharmacies to gather opinions on how to address side effects that could damage the healthcare delivery system. The public hearing for the non-face-to-face medical treatment pilot project should be held in a format where the Ministry of Health and Welfare directly discloses the prescription statistics and patterns that occurred during the guidance period over the past three months, while also collecting opinions on solutions that will erode concerns about the concentration of prescriptions for high-risk non-reimbursed drugs and concerns about platform side effects. It should not just be a formality and a basis-building effort to expand the scope of non-face-to-face first and return visits. The slogan that face-to-face treatment is the principle and non-face-to-face treatment is an auxiliary means was put forward every time the Ministry of Health and Welfare insisted on the need to implement pilot projects and legislate. The Ministry of Health and Welfare is breaking the principles of face-to-face treatment by discussing a pilot project reform plan that blindly expands the scope of first and repeat visits without any valid basis.
- Policy
- Monterizine generics prepare for release in Oct
- by Lee, Tak-Sun Sep 13, 2023 05:28am
- Hanmi Pharm’s asthma and rhinitis combination drug Companies are preparing to release their generic versions of Hanmi Pharm’s Monterizine (Montelukast+Levocetirizin) in October at the earliest. The generic drugs that were approved in August obtained first generic exclusivity and were able to move up their reimbursement listing date. According to the industry sources on the 8th, the price calculation process for Monterizine generics has been completed and it is expected to be listed with reimbursement next month. HIRA is known to have been conducting pricing calculations for Monterizine generics that applied for reimbursement after being approved in August. The generics, which received generic exclusivity, are expected to be released in October. Unlike general drugs that take 3 months to reimbursement listing, it only takes 2 months for drugs that are granted generic exclusivity to reimbursement listing. 10 Monterizine generics that were granted generic exclusivity by HIRA are owned by Genupharma, Huons, Daehwa Pharmaceutical, DongKoo Bio&Pharma, Binex, Boryung Pharmaceutical, Daewon Pharmaceutical, Daewoong Pharmaceutical, Medica Korea, and Jeil Pharmaceutical. The difference between the generics and the original Monterizine Capsule is that the to-be-released generics are tablet formulations. The pharmaceutical companies succeeded in avoiding Monterizine’s formulation patents with that difference. The MFDS therefore granted them exclusive rights so other companies may not sell the same drug until May 2024. Monterizine is Hanmi’s incrementally modified drug that it received approval in May 2017. It is the world’s first combination of montelukast, which blocks the action of leukotriene that causes tightening of airway muscles, breathing difficulties, and runny nose, and levocetirizin hydrochloride, an antihistamine used to treat allergic rhinitis. Hanmi demonstrated its combination’s superior efficacy compared to a single agent in a Phase III trial targeting domestic patients. Monterizine exceeded the blockbuster drug threshold of KRW 10 billion for the first time last year. Based on UBIST, the amount of its outpatient prescriptions was KRW 11.5 billion last year, up 24% points from the KRW 9.3 billion it had posted in the previous year. Supported by its marketability, the generic companies are expected to make efforts to market their drugs early into their release. An official from a related company said, "Because it is effective in relieving allergic rhinitis symptoms in patients with asthma and perennial allergic rhinitis, we expect to achieve high performance if we focus on marketing our product to HCPs in Korea." The current insurance ceiling price of Monterizine Cap is KRW 886/capsule. Hanmi also owns a chewable tablet formulation of the same drug at the same price.
- Policy
- BT public-private council will soon resume operations
- by Lee, Jeong-Hwan Sep 13, 2023 05:28am
- The Ministry of Health and Welfare is expected to soon resume the operation of the 'BT (breakthrough therapy) Public-Private Council', a pharmaceutical industry discussion body necessary for establishing and implementing BT price preference policies. The Ministry of Health and Welfare is expected to establish standards for preferential drug prices based on the results of discussions at the BT public-private consultative body held from February to April, and then finalize them after gathering opinions from the pharmaceutical industry at the public-private consultative body, which is scheduled to resume as early as this month. In the case of the public-private consultative body to reform the generic drug price system, there has been no concrete movement yet, and as the Ministry of Health and Welfare has begun research on the form of private contracts, the atmosphere is waiting until the research is completed and the analysis of the results is completed. According to the pharmaceutical industry on the 11th, the Ministry of Health and Welfare recently met with three pharmaceutical organizations along with NHIS and HIRA and held a public-private consultative body to discuss pending issues of reforming the drug price system. At this meeting, the Ministry of Health and Welfare reportedly announced plans to resume the public-private consultative body in the near future and confirm the BT preferential treatment standards in response to inquiries from the three pharmaceutical organizations regarding the BT preferential drug price policy. It has been reported that the Ministry of Health and Welfare's position is to partially accept the demands of the three pharmaceutical groups not to announce preferential policies without prior discussion or to immediately submit them to the Health Insurance Policy Deliberation Committee agenda. Pharmaceutical industry officials are observing that the Ministry of Health and Welfare has already reached the stage of completing the internal establishment of BT preferential standards and measures. It is explained that the Innovative New Drug Public-Private Consultative Body, which will be launched in September at the earliest or early October at the latest, will decide on what criteria and how to give preferential treatment to the prices of drugs made by innovative pharmaceutical companies. The Ministry of Health and Welfare and NHIS have announced plans to announce BT preferential measures within September at a National Assembly debate and press conference. The public-private consultative body that will discuss the generic drug price system, including comprehensive generic drug price cuts, is showing no significant movement. Previously, in July, the Ministry of Health and Welfare signed a private contract with Professor Kim Dong-sook of Kongju University's research team for a research project to 'prepare a plan to improve the generic drug price system', so the pharmaceutical industry predicts that the implementation of the system related to generic drug price reduction will be delayed until the study is completed and the results are analyzed. This is the consensus of experts. Last April, under the direction of Second Vice Minister Park Min-soo, the Generic Drug Price System TFT was formed and the reform of the drug price system was initiated. Compared to the time when the pharmaceutical industry expressed concern that the government might immediately move to reduce generic drug prices in batches, some portion of the system has not been implemented. It has been delayed. An official in the domestic pharmaceutical industry explained, “We requested the Ministry of Health and Welfare to publicly announce the drug price preferential treatment plan after going through the BT public-private consultative body and go through a sound review process, and they responded that they would accept it.” He explained, “Research on the generic drug price system reform plan, including generic drug price cuts, is scheduled to be studied until this year, and discussions are expected to begin only after next year.” This official said, “Fear or backlash over the wholesale price cut for generics has been delayed until the end of the study, but just reevaluating the comparison of overseas drug prices right now is a significant burden on pharmaceutical companies.” He added, “I hope that the Ministry of Health and Welfare will create the system together rather than unilaterally establish the system and then go through a formal opinion-gathering process.”
- Policy
- Will Enhertu pass PE evaluations for reimb in KOR?
- by Lee, Tak-Sun Sep 13, 2023 05:28am
- Due to delays in the review of the economic feasibility of the anticancer drug Enhertu (trastuzumab deruxtecan), the industry is seeing delays in its reimbursement agenda being submitted for deliberation to the Drug Reimbursement Evaluation Committee. The agenda had previously passed the Cancer Disease Deliberation Committee review after redeliberation in May. The company expects to receive positive results at the Pharmacoeconomic Evaluation Subcommittee meeting in October. According to industry sources on the 12th, Daiichi Sankyo recently submitted supplementary pharmacoeconomic evaluation data to HIRA for its Enhertu and expects to pass HIRA deliberations in October. Enhertu passed the CDDC review after redeliberations in May. The committee determined Entertu reimbursable for the treatment of ▲unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens (third-line or higher treatment), and ▲locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior therapies including an anti-HER2-based regimen (third-line or higher treatment) As a result, the agenda was supposed to be submitted for deliberation by the Drug Reimbursement Evaluation Committee. However, it seems that the company and the government are having difficulty reaching a consensus in the pharmacoeconomic evaluation process. Daiichi Sankyo submitted the PE evaluation data in July, but was unable to reach an agreement with HIRA. The industry analysis is that Enhertu's superior effect is hindering economic evaluations. Currently, the Pharmacoeconomic Evaluation Subcommittee is evaluating the cost-effectiveness of Enhertu compared to Kadcyla. However, as Enhertu demonstrated an extension in progression-free survival (mPFS) by more than 22 months compared to existing drugs, and the increase in the administration period that followed, there have been limitations in proving the cost-effectiveness of the drug using the current economic evaluation method. Even so, Daiichi Sankyo has accepted most of the deliberation results from the last Pharmacoeconomic Evaluation Subcommittee’s deliberation in order to quickly receive reimbursement. The company had requested redeliberation on some aspects that are difficult to accept. Daiichi Sankyo recently submitted the supplementary materials and is expecting positive results at the Pharmacoeconomic Evaluation Subcommittee meeting that will be held in October. In the paper, ‘Analysis of Socioeconomic Indirect Cost of Premature Death in Patients with HER2-positive Metastatic Breast Cancer (MBC) using Nationwide Claims Data’ that was recently published on Yakhak Hoeji on August 31, research teams of Sungkyunkwan University’s School of Pharmacy and Samsung Medical Center showed that socioeconomic benefits were greater with the administration of Enhertu. The research teams identified the claims data of 2,212 patients with HER2-positive MBC who were prescribed trastuzumab-emtansine as a second-or-higher-line of treatment from January 2007 to May 2021 using nationwide insurance claims data to estimate the progression-free survival (mPFS) and the resulting socioeconomic benefits. As a result, the mPFS of trastuzumab-emtansine ranged from 7.1 months (age 65 or older) to 12.5 months (age 30s), and the mPFS of trastuzumab-deruxtecan (Enhertu) was more than three times longer for all ages, ranging from 23.4 months (age 65 or older) to a maximum of 41.1 months (age 30). Accordingly, the socioeconomic benefits brought about by the extended PFS with the use of trastuzumab-deruxtecan (Enhertu) compared to existing drugs were estimated to amount to KRW 261.4 billion, which is averages to KRW 118 million per patient. An official from Daiichi Sankyo Korea said, "We hope that the authorities will review Enhertu’s reimbursement more flexibly, in consideration of the various aspects such as social losses of breast cancer and the extension of patients' lives that can be expected through Enhertu treatment under the framework of Korea’s current pharmacoeconomic evaluation system.
- Policy
- Forxiga's generics, advertised for off-label indications
- by Lee, Hye-Kyung Sep 12, 2023 05:37am
- Forxiga's generic development companies that promoted 'chronic heart failure, chronic kidney disease' in their drug advertisements were subject to administrative sanctions. On August 18th and 22nd, the Ministry of Food and Drug Safety suspended Boryung and Aju Pharmaceuticals from advertising for products containing Dapagliflozin for three months, respectively. The objects of disposal are three items, including Boryung's Trudapa 10 mg (Dapagliflozin Bis L-proline), Trudapa M SR 10/500 mg (Dapagliflozin, Metformin), and Trudapa M SR 10/1000 mg (Dapagliflozin, metformin). and Aju Pharmaceutical's Daparil 5 mg (Dapagliflozin Propanediol Hydrate), Daparil 10 mg (Dapagliflozin Propanediol Hydrate), Daparil Duo SR 10/500 mg, Daparil Duo SR 10/1000 mg, etc. There are 4 items. They were subject to administrative action after it was discovered that they used pamphlets targeting doctors and advertised content other than the approved efficacy and effects. The original, AstraZeneca Korea's Forxiga, has three indications, including type 2 diabetes, chronic heart failure, and chronic kidney disease, but the generic developed by domestic pharmaceutical companies only has type 2 diabetes as an indication. In this situation, Forxiga's generic companies became subject to administrative action by producing and distributing promotional materials containing claims that the drug was effective against chronic heart failure and chronic kidney disease, which are unauthorized indications. The only companies to which the Ministry of Food and Drug Safety has issued administrative measures are Boryung and Aju Pharmaceuticals, but as the number of domestically approved products for Dapagliflozin reaches 222, the likelihood that other pharmaceutical companies will also be subject to administrative measures if they advertise for indications other than those approved has increased. The efficacy or performance of pharmaceuticals cannot be advertised unless permission or modification is granted in accordance with Article 68 of the Pharmaceutical Affairs Act. In the case of a first violation according to the standards for administrative disposition in Table 8 of the Rules on the Safety of Medicines, etc., the advertising business for the product concerned will be suspended for 3 months. As it became known that generic drug developers were promoting non-approved indications, AstraZeneca Korea sent a certificate of contents to the companies in question, leading to an inspection by the Ministry of Food and Drug Safety. Meanwhile, after Forxiga's substance patent expired last April, a total of 90 pharmaceutical companies entered the market with 105 single-drug products and 64 combination products approved. According to UBIST, a pharmaceutical market research firm, the outpatient prescription performance of Dapagliflozin single and combination drugs in May was 11 billion won. The sales of the original Forxiga were 4.7 billion won, and those of Xigduo were 4.1 billion won, accounting for about 80%. The remaining 2.2 billion won was accounted for by generics Forxiga and Xigduo. As of May, 60 pharmaceutical companies recorded a total of 1.436 billion won in prescriptions for single drugs, and 31 pharmaceutical companies recorded a total of 772 million won in prescriptions for combination drugs.
- Policy
- Pfizer’s ALL drug Besponsa renews RSA in KOR
- by Lee, Tak-Sun Sep 12, 2023 05:37am
- Pfizer Korea’s acute lymphoblastic leukemia (ALL) treatment ‘Besponsa (inotuzumab ozogamicin)’ has recently renewed its risk-sharing agreement (RSA) with the government. The company had signed an Expenditure Cap Type RSA for the drug in 2019. According to the National Health Insurance Service and industry sources on the 11th, Besponsa recently completed negotiations on renewing its RSA with the NHIS. This drug is reimbursed as a treatment for adult patients with relapsed or refractory ALL, regardless of their Philadelphia Chromosome mutation status. At the time of its reimbursement in October 2019, the drug was only approved for patients with Philadelphia chromosome-negative ALL, however, its reimbursement was extended to allow use regardless of Philadelphia Chromosome mutation status since February last year. Besponsa is the first antibody-drug conjugate introduced to ALL. It is a combination of an antibody, inotuzumab, which targets the CD22 antigen expressed on the surface of B cell precursor ALL cancer cells, and the cytotoxic drug calicheamycin to induce death and destruction of cancer cells. The company explained that the combination showed a stronger effect than existing chemotherapy and significantly improved the complete response rate compared to existing chemotherapy, helping patients successfully undergo hematopoietic stem cell transplantation. This drug, which signed a 4-year expenditure cap-type RSA at the time of reimbursement listing, will maintain its refund contract with the government for 5 more years until September 2028 through the RSA renewal. The contract term, which had been 4 years at the time of the first RSA signing, has now been extended to 5 years. Besponsa's current list price is KRW 11,445,800/vial. Based on IQVIA, it raised sales of KRW 5.6 billion in 2022.
- Policy
- Vytorin generics suffer blow from reevaluations
- by Lee, Tak-Sun Sep 11, 2023 05:30am
- The hyperlipidemia combination ‘Vytorin (ezetimibe+ simvastatin) suffered a direct blow from the insurance price ceiling reevaluations conducted in Korea. As a result, only two companies were able to maintain the highest insurance ceiling price for their generics. In particular, Genuone Sciences was the only company to maintain the highest ceiling price in the 10/10mg group. According to industry sources, the price ceiling of Vytorin generics had been reduced for 60 of the items (21 10/10mg dosage forms and 28 10/20 dosage forms) as a result of the price ceiling reevaluations. As a result, only Genuone Science’s Vyteb Tab was able to maintain its highest insurance ceiling price at KRW 784 among the 10/10mg dosage forms. Previously, 26 items had been sold at the highest price of KRW 784. In the case of the 10/20mg dosage forms that contain 20mg of simvastatin, the number of highest-priced drugs (KRW 1,095) was reduced to 2 - Genuone Sciences’ Vyteb 10/20mg and Korea United Pharm’s SImpex Duo Tab 10/20mg. Previously, 17 items had been sold at the highest price. The price of the original Vytorin fell from having the highest price due to a price cut made on January 1, 2022. Accordingly, Vytorin tablets 10/10 mg are priced at KRW 781, and 10/20 mg at KRW 1091. The insurance price ceiling set for products whose price was reduced by 15% because it does not meet one of the standard requirements is KRW 666 for the 10/10 mg dose and KRW 931 for the 10/20 mg dose. Of the 35 10/10mg products, 32 were priced lowest at KRW 666, and 28 of the 32 10/20mg products were priced lowest at KRW 931.
- Policy
- Next year's new drug R&D budget: 58 billion won
- by Lee, Jeong-Hwan Sep 08, 2023 05:34am
- The Ministry of Health and Welfare has set the national new drug development (R&D) budget for next year (2024) to 57.99 billion won, an increase of about 16.1 billion won from this year's budget of 41.19 billion won. 10.4 billion won was allocated to research to expand the new drug base, 16.5 billion won to research to build a new drug R&D ecosystem, 8.6 billion won to clinical development of new drugs, and 19.1 billion won to support the development of excellent new drugs to promote global expansion and partnerships. On the 6th, the Ministry of Health and Welfare submitted next year's budget plan to the National Assembly with these contents. National new drug development is a national task of the Yoon Seok-yeol administration. We have set a national scheme to become a global center for bio and digital health and to join the G5 in science and technology by fostering super-gap strategic technologies. The total budget for the project increased compared to the previous year, but most of the items have decreased if you look at the detailed project details. This is due to a decrease in the existing business budget as a new budget for promoting global expansion and partnership worth close to 20 billion won was established. Specifically, 10.465 billion won was earmarked for next year's budget for 'acid drug-based expansion research' to support researchers in deriving active substances and lead substances in order to continuously supply an early-stage new drug pipeline that is qualitatively and quantitatively excellent, compared to this year's 12.76 billion won. This is a decrease of 2.295 billion won compared to 10,000 won. Next year's budget for research on building a new drug R&D ecosystem is also 16.491 billion won, a decrease of 560 million won compared to this year's 17.051 billion won. The goal of the budget is to build an ecosystem that can smoothly connect basic research and clinical research and to intensively foster small and medium-sized enterprises and venture companies. Next year's budget for new drug clinical development has increased. 8.685 billion won was allocated, which is 645 million won more than this year's budget of 8.04 billion won. It is used to support phase 1 and 2 clinical trials for company-centered new drug development and global-level technology transfer. Next year's budget for new drug R&D commercialization support, which supports the resolution of barriers in significant stages of new drug development such as clinical trials, technology commercialization, and manufacturing/production, is 719 million won, a whopping 36.3% decrease from this year's 1.147 billion won. The amount was reduced by 428 million won. Next year's business unit operating expenses are 2.424 billion won, a 10.6% increase from this year's 2.192 billion won. The budget to support the development of excellent new drugs to promote global expansion and partnering, which will be deployed starting next year, is 19.125 billion won. The goal is to intensively foster and support next-generation new drugs that the global pharmaceutical and bio industries are paying attention to. KRW 2.363 billion is spent on lead drugs, 5.437 billion won on candidate drugs, 5.625 billion won on non-clinical trials, and 5.7 billion won on clinical trials. Specifically, the Ministry of Health and Welfare established a new budget to secure differentiated competitiveness and support new drug technologies that can actively advance into the global market. The intention is to strengthen global cooperation to intensively foster and develop next-generation food and new drugs such as ADC, TPD, new targets, and modalities, and to promote five projects that will be successfully carried out. The Ministry of Health and Welfare expects that after 2024, the expected effects will be to expand the domestic new drug development base by deriving excellent effective substances and lead substances, establishing a new drug R&D ecosystem, and enhancing company-centered new drug development capabilities.
- Policy
- Advanced biologics to receive expedited review
- by Lee, Hye-Kyung Sep 08, 2023 05:33am
- Advanced biological drugs that have demonstrated a significant improvement in safety or effect compared to existing treatments will be regarded as ‘drugs with no alternatives’ and allowed to receive expedited review in Korea. Until now, only advanced biopharmaceuticals with limited scope of application (such as patients who have positive or negative biomarkers) compared to existing treatments or those for patients who are unresponsive to existing treatments were regarded as ‘drugs with no alternatives.’ However, the Ministry of Food and Drug Safety decided to expand treatment opportunities for patients with rare and incurable diseases by revising the regulations and allowing expedited processing for biopharmaceuticals that have proven improved safety or efficacy compared to existing treatments. On the 7th, the MFDS issued a pre-announcement of administration of the ‘Partial amendment of the marketing authorization and review regulations for advanced biopharmaceuticals' and announced that it will expand patient treatment opportunities and harmonize domestic and foreign standards and regulations. Article 21 of the regulations that will be amended contains the designation of subjects eligible for fast-track review, which includes cases where there are no alternative treatments. Such cases were defined as ▲ cases where there are no domestically approved drugs, and ▲ cases where the target of application is limited due to the existence of positive or negative biomarkers compared to existing treatments, or cases where existing treatments cannot be used. When targeting patients who could not receive it or were unresponsive, it was limited to cases where there were no alternative treatments. However, through the amendment, the government decided to designate advanced biopharmaceuticals that have proven to have significantly improved safety or effectiveness, as well as drugs where production, import, and supply have been suspended and supply has not been resumed, as those subject to fast track review. In addition, probiotics were included in the definition of biological drugs, and the legal basis for restricting marketing authorization for gene therapies was specified as 'Article 11 (1) 9 (c) and (1) of the Rules on the Safety of Drugs, etc.' Also, terms such as quality review and quality evaluation were unified into standards and test method review, and provisions based on submitted data for conditional approval were also revised. The MFDS is accepting opinion submissions about the pre-announced administrative notice until November 6.
- Policy
- Yooyoung will newly release repackaged flagship Pravafenix
- by Lee, Tak-Sun Sep 07, 2023 03:50pm
- Yooyoung Pharmaceutical has voluntarily withdrawn the marketing authorization for its product, ‘Pravafenix Cap’, as the product is due for a packaging renewal. As a flagship product, Pravefenix Cap has been recording annual sales of approximately 20 billion KRW. The newly self-packaged product is expected to be listed for reimbursement this upcoming October. According to the industry, Yooyoung Pharmaceutical voluntarily withdrew its permit for Pravafenix Cap (pravastatin+fenofibrate) on the 18th. This comes 11 years after the company first received approval in July of 2012. The drug is a treatment for dyslipidemia, imported from the Belgian pharmaceutical company, SMB. Since then, the drug has settled as a flagship item and has long served as Yooyoung's cash cow. Based on UBIST, the drug reached an outpatient prescription sales of 21.4 billion KRW last year. Considering Yooyoung’s total sales being approximately122.1 billion KRW last year, Pravafenix accounted for a high proportion of the company’s total sales. The company received approval for ‘Yooyoung Pravafen Cap’ in February before withdrawing its approval for the existing Pravafenix. In the past, Yooyoung imported Pravafenix from SMB as fully packaged finished goods under an import permit. The new manufacturing approval for Pravafenix allows for the company to import the capsules in bulk and package the products at Yooyoung’s manufacturing facility. The company explained that this decision was made to flexibly respond to market demands. The newly packaged drug is expected to be listed for reimbursement in October. A company official stated that Yooyoung voluntarily withdrew the import permit in order to use the trademark “Pravafenix Cap”, as for the MFDS would not allow two authorizations under identical names. The product name of the new manufactuiring approval has been changed from “Pravafen Cap” to “Pravafenix Cap”. He added, "The newly released Pravafenix Cap is expected to be reimbursed from October, however reimbusment may be claimed for the original Pravafenix Cap as well during a short overlapping period in order to minimize supply interruptions. Although some domestic companies are developing generic versions of Pravafenix, there has been no news of an item receiving marketing authorization yet.
