- LOGIN
- MemberShip
- 2025-12-24 10:00:59
- Policy
- Ticagrelor Napadisylate by Chong Kun Dang was applied
- by Lee, Tak-Sun Jul 07, 2020 06:13am
- It has been shown that Chong Kun Dang developed a salted product of Ticagreler (Brilinta, AstraZeneca) and applied for permission to the MFDS. It is the first product to be approved as a Ticagrelor salt product. Anti-thrombotic agent, Ticagrelor, is a poorly soluble drug and is known to have poor solubility, so it has been noted whether salted drugs can overcome disadvantages. According to the industry on the 6th, Chong Kun Dang developed Ticagrelor napadicylate and applied to the MFDS on the 26th of last month. AstraZeneca Korea’s Brilinta (Ticagreler) was approved in July 2011. This product has indications that reduce the incidence of thrombotic cardiovascular events (death due to cardiovascular events, myocardial infarction, stroke) in combination with Aspirin in adult patients. Domestic pharmaceutical companies have made generics for Brilinta and have been sequentially approved since November 2017. However, due to the remaining material patents, it cannot be launched immediately, and will be sold from November next year. 25 items have obtained the right to monopolize the market from November 21, 2021 to August 20, 2022 by obtaining generic exclusivity by overcoming the remaining patents excluding material patents. Chong Kun Dang also obtained generic exclusivity. It is Ticarex 90mg which is unsalted form of Ticagreler. Accordingly, it is expected that Chong Kun Dang will release salt added products and salt free products simultaneously. In particular, it is expected that the salt additive product has improved solubility of Ticagrelor and will be able to secure competitiveness in the market. Brilinta is a blockbuster drug with a record of ₩10.3 billion in outpatient prescriptions (based on UBIST) last year.
- Policy
- Daewoong's Camostat was approved for clinical trial phase II
- by Lee, Tak-Sun Jul 07, 2020 06:12am
- Daewoong’s FoistarDaewoong has been approved for clinical trials in patients with mild and moderate COVID-19 as a drug with Camostat Mesilate used as a treatment for pancreatitis. The MFDS approved a plan for phase II clinical trial for 'DWJ1248', which Daewoong applied for on the 6th. DWJ1248 is known as Camostat Mesilate. Daewoong holds Foistar (Camostat Mesilate). This clinical trial is a double-blind, randomized, placebo-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of DWJ1248 in 90 patients with mild and moderate COVID-19. A team of researchers from Georg-August-Universität Göttingen is raising hopes as a candidate for COVID-19 treatment by announcing the results of an experimental study in which the Camostat prevents lung cell infection of COVID-19 in the global journal “Cell”. The research team at Aarhus University Hospital in Denmark started a phase II clinical trial to check the effectiveness of COVID-19 of Camostat Mesilate after receiving research funding from the Lundbeck Foundation. In Korea, Crystal Genomics was approved for the first time in a phase II clinical trial to evaluate the effectiveness and safety of Camostat for COVID-19.
- Policy
- Stepped drug pricing applied on maximum price as of Aug 1
- by Kim, Jung-Ju Jul 07, 2020 06:12am
- The Korean government unveiled the specified schedule and plan to apply stepped drug pricing system, also known as the upper limit price reevaluation on listed drug. Although the Regulatory Reform Committee ordered Ministry of Food and Drug Safety (MFDS) to drop the ‘1+3 joint bioequivalence test system’ from the revised ‘Regulation on Pharmaceutical Approval, Notification and Review,’ the health authority’s intention to limit joint bioequivalence test and to promote drug master file (DMF) registration are still apparent in the newly revised policy. Ministry of Health and Welfare (MOHW) officially disclosed the ‘Plan on Reevaluating Pharmaceutical Maximum Reimbursed Price,’ and spoke of the key dates such as a base date for reevaluated pricing and evidence submission period for the responsible pharmaceutical and bio companies. ◆Reevaluation subject and exemption conditions: Drugs listed for reimbursement before the government finalized the ‘Pharmaceutical Decision and Adjustment Criteria (MOHW notice No. 2020-51)’ as of Feb. 28 are subject to the reevaluation. But some are exempted from the reevaluation; drug requested for decision by the President of Korea Orphan and Essential Drug Center (KOEDC), or oxygen, nitro oxide, basic parenteral nutrition, artificial perfusates and radiopharmaceuticals are ruled out from the reevaluation. Other exempted drugs include low-cost drug, shortage prevention drug, orphan drug and other drugs specifically designated by the Minister of Health and Welfare, according to the Example 가 (Ga) to 라 (Ra) of the Item 2 of the Notice Appendix 4, that require stable supply and management essential for medical service. Moreover, a first drug in the class to be listed is also excluded from the list of subject drugs. If the first-in-class drug is not on the list of reimbursed drugs, the drug that MFDS notified as a reference drug for bioequivalence test among the same substance drugs would be considered as the first-in-class drug. ◆Adjusted drug pricing and criteria: The base price for the upper limit pricing adjustment (reduction) is the maximum price among the same substance drug. However, drugs with premium pricing benefit would base their reevaluation on the original pricing without the premium. As announced previously, the maximum price of a listed drug would be reduced by passing two, one or none of the criteria—submitting individual bioequivalence test data or clinical trial confirmation data, and submitting evidence of using active pharmaceutical ingredient registered with DMF. A drug meeting two of the criteria would receive the maximum price lowered to the adjusted base price, and meeting one criterion would lower the price down to 85 percent of the base price. And the maximum price of a drug clearing none of the criteria would be reduced to 72.25 percent of the adjusted base price. MOHW does not plan to lower the maximum price of a drug with the price already lower than the adjusted base price. And if the adjusted price is lower than the base price of a low-cost drug, the maximum price would be reduced down to the low-cost drug’s base price. But the pricing would be adjusted as the original policy, if an item is listed with minimum unit (1 mL, 1 g, 1mCi etc.) or its maximum price is labeled with minimum unit. The bioequivalence test reference drug, not a first-in-class drug, would be only considered to have met the first criterion of submitting the individual bioequivalence test evidence or submitting the evidence of clinical trial. ◆Evidence submission: For the pharmaceutical companies to get the most of the maximum pricing, the reevaluation criteria should be met. The government has set the deadline on Feb. 28, 2023 for the evidential materials to be submitted to Health Insurance Review and Assessment Service (HIRA). Other details would be fine-tuned further by discussing with Drug Reimbursement Evaluation Committee (DREC).
- Policy
- Samsung Bioepis' Adalloce prefilled pen was approved
- by Lee, Tak-Sun Jul 06, 2020 06:15am
- Samsung BioepisSamsung Bioepis’ pen type product of Humira (Adalimumab) biosimilar named Adalloce has additionally approved in Korea It is evaluated as a product with improved convenience of administration than Adalloce PFS that was approved in September 2017. The MFDS approved Samsung Bioepis' Adalloce prefilled pen 40mg on the 3rd. This product is an injection type in a pen equipped with a colorless and transparent pre-filled syringe. It is a self-injectable form that can be administered by the patient himself, such as the previously approved Adalloce PFS. However, the pen formulation has the advantage of not only reducing the fear of the injection needle due to the lack of exposure to the injection needle, thereby reducing the possibility of contamination. Adaloche prefilled pen is simple to use because the injection drug is automatically injected by pressing the button on the injection site. Humira, which is the original drug of this product, has both pre-filled syringe and pre-filled pen formulations, and the preference of pen formulations is high. It has been reported that most patients with pen formulation experience pain reduction following injection. Adalimumab is mainly used in patients with rheumatoid arthritis. However, Adalloce has not yet been released in Korea. This is because Humira's fastest patent expires in June 2022. However, Samsung Bioepis succeeded in invalidating the Humira patent, which was scheduled to expire on July 18, 2023, through a trial request, and laid the foundation to release it sooner. Currently, Samsung Bioepis' Adalloce is the only product that has the same ingredient (Adalimumab) as Humira in Korea. Last year, Humira's domestic sales (based on IQVIA) amounted to ₩96.2 billion, and it is a very large-scale drug that is close to ₩100 billion. Samsung Bioepis has been selling Humira's biosimilar in Europe since October 2018 under the name Imraldi. Biogen, which sells Imraldi in the European market, said last year that its sales were $184 million, more than 10 times higher than ₩16.7 million in 2018. It is the No. 1 market share in Humira biosimilar products. It is an analysis that Imraldi is leading among the four biosimilars due to the advantages of price competitiveness and convenient pen formulation in the European market. It is highly anticipated that it will become a competitive with Humira if it is released in Korea.
- Policy
- Pariet holder was changed from Janssen to Kolmar in 20 years
- by Lee, Tak-Sun Jul 06, 2020 06:15am
- The domestic license holder for 'Pariet', a PPI used for GERD, has been changed in 20 years. As Janssen Korea operates the Hyangnam factory until next year, the manufacturer has finally changed. Eisai Korea is in charge of sales. According to related industries on the 3rd, the permit holders of Pariet licensed in 2000 were changed from Janssen Korea to Kolmar Korea, and an insurance code was newly established reflecting this from July. Accordingly, items whose license holder is Janssen Korea can only be claimed by this December. Since last year, Janssen Korea has been in the process of transferring manufacturing. This is because the operation of the Hyangnam Plant until next year will no longer produce Pariet, which was commissioned and manufactured in Korea. It is developed by Eisai, and Eisai Korea is in charge of sales. Janssen Korea has established a relationship since Pariet launched in Korea in 2000. In addition to permitting, manufacturing and production, the company also conducted joint sales with Eisai Korea. It closed sales in 2015, and was transferred to Kolmar Korea at this time. Pariet has recently released a low dose product, and is strengthening its marketing by conducting joint sales with Yuhan Corporation. Pariet is also receiving reflex benefits according to anti-ulcer drug Ranitidine has been banned due to the detection of NDMA, a carcinogen, It is noteworthy whether Pariet, whose license has changed from Janssen Korea to Kolmar Korea in 20 years, will making its way up once again in Korea with a new partnership.
- Policy
- Korean government designates remdesivir essential drug
- by Lee, Tak-Sun Jul 06, 2020 06:14am
- Product image of remdesivir (Source: BBC) The Korean government has designated specially imported COVID-19 treatment remdesivir, and clinically used COVID-19 treatment Kaletra (lopinavir/ritonavir) as National Essential Drugs. National Essential Drugs are designated to be constantly monitored for stock and supply flow, and to receive support for special importation clearance or contract manufacturing in Korea in case of shortage. After a pan-government deliberation, the Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-kyung) has decided expand the list of National Essential Drug from 403 items to 441 on July 2 to better manage the supply of drugs used to respond against disaster or emergency like COVID-19. Minister of Health and Welfare and Minister of Food and Drug Safety come together to agree on the special designation of drugs necessary in the healthcare scene but cannot solely rely on the function of market to stabilize flow of supply. The pan-government meeting for the essential drugs designation consists of nine government bodies including MFDS (chair), Ministry of National Defense, Ministry of the Interior and Safety, Ministry of Health and Welfare and Office for Government Policy Coordination. The latest list newly added total 38 items, such as three COVID-19 relevant drugs (remdesivir injection, lopinavir and ritonavir solutions), 31 drugs to respond against disaster or emergency (epinephrine used for CPR), and four items recommended by related government body like Korea Centers for Disease Control and Prevention (KCDC). Now the National Essential Drug list has 441 items consisting of four COVID-19 related treatments, 46 disaster response or emergency care treatments, 31 emergency antidotes, 31 tuberculosis treatments, 99 hepatitis virus, parasite and other infectious disease treatments, 33 vaccines, and 10 basic parental nutrition solutions. The government constantly monitors supply and stock of the essential drugs, and takes prompt actions to stabilize the supply by MFDS clearing special importation or using contract manufacturing organization to domestically supply the products. MFDS official said, “More of National Essential Drugs would be designated in the future to securely grant patient access to drugs in desperate need of special management,” and “The government would always strive to supply drugs essential to the public health.”
- Policy
- 33 seriously ill patients are eligible for free Remdesivir
- by Kim, Jung-Ju Jul 03, 2020 06:18am
- Gilead Science Korea's COVID-19 treatment 'Remdesivir' was supplied to Korea on the 1st of today. A total of 33 seriously ill candidates will be eligible for the first free application. However, they request to be administered at the discretion of the attending physician, and whether or not to administer is determined according to the selection criteria. Jung Eun-Kyeong, Head of Central Disease Control Headquarters at the KCDC, today (1st) at the regular briefing, explained the number and severity of serious patients currently considered as the primary target. According to the Head Jung, there are reports that Remdesivir shortens the treatment period through several clinical trials. Statistically, it is still unclear, but the supply was decided by special import because the drug is expected to reduce the mortality rate. The government has decided on the selection criteria for the target of the treatment so that it can be administered to patients who have not passed 10 days, which can be called early onset. In addition, it was limited to patients receiving oxygen therapy which chest x-ray or CT pneumonia, oxygen saturation was 94% or less. Jung Eun-Kyeong, Head of Central Disease Control Headquarters said, "The criteria for this medication were selected in consideration of experts' advice and recommendations from the central clinical committee operated by the National Medical Center, and by the MFDS, but the request is made at the discretion of the attending physician.” She added that there are basic treatment policies in the early stages of the onset such as administering antiviral drugs to suppress the growth of viruses, and using treatments such as Dexamethasone, which has anti-inflammatory effects, depending on the progress. It will be necessary to check the dosing criteria while checking the onset period. On the other hand, as of 2:50 pm on the first day that the application for medication was started, there are no medical institutions that have requested to apply for Remdesivir.
- Policy
- It started supplying Remdesivir to Korea for free for July
- by Lee, Tak-Sun Jul 03, 2020 06:17am
- Remdesivir (BBC)Gilead's 'Remdesivir', a COVID-19 treatment, is supplied to Korea. In the month of July, the supply will be used free of charge. It is planned to be purchased and used through price negotiations after August. The director of The KCDC (Jung Eun-Kyeong) announced that it will supply Remdesivir, which was specially imported as a treatment for COVID-19, from July 1. On June 29, after the MFDS' decision on special imports, the KCDC signed a free drug supply contract with importer Gilead Science Korea (USA) on the 29th of last month through consultation on domestic introduction. However, it was decided that the amount of introduction would be closed according to the terms of the contract with Gilead. Patients who can receive Remdesivir are limited to severe patients with pneumonia and who need oxygen therapy. Therefore, hospitals that treat severely ill patients should request the National Medical Center to supply medicines, and the National Medical Center, if necessary, consults with the central clinical committee for emerging disease control to determine who should be administered. Jung Eun-Kyeong, Director of the KCDC, said, "We plan to do our best to secure treatments by continuing to cooperate with Gilead Sciences Korea to secure additional volumes of Remdesivir." The KCDC plans to secure free supplies until July, and purchase from price negotiations after August.
- Policy
- Lipiodol takes government’s pricing reduction to the court
- by Kim, Jung-Ju Jul 03, 2020 06:17am
- The government’s price reduction on Lipiodol Ultra Solution (iodized oil), supposed to be effective from July 1 with the release of generic, is now heading to the courts as the company objected to the decision. Until the judgment is made, the court has allowed Guerbet Korea to sell the drug for the original reimbursed price temporarily. The Seoul Administrative Court has ordered a suspension on the execution of the new list of reimbursed drugs and maximum reimbursed price, as the company filed a litigation case to drop the government’s action. On June 23, Korea’s Ministry of Health and Welfare (MOHW) has initially decided to lower the pricing of Lipiodol as the generic drug Fattiodol by Dongkook Pharmaceutical was listed. According to the government’s calculation of reimbursed drug price, MOHW authorizes adjustment of maximum prices of first-in-class drug and other products with the same administration method, substance and formulation when a generic drug is listed. The initial adjustment of the pricing would have lowered the price of Lipiodol in 12.8 g/ 10 mL dose at 190,000 won to 133,000 won by 30 percent from July 1. And the premium pricing benefit on the original was supposed to be removed from May 1 next year, which would once again lower the pricing from 133,000 won to 101,745 won. However, the company has filed litigation against the government decision and now the court is taking over the decision. The original price of 190,000 won would be temporarily maintained until Aug. 24. But if the case extends in longer period of time, the suspension of the pricing reduction would also be prolonged. For now, MOHW plans to follow the court’s order until Aug. 24, and inform further changes accordingly.
- Policy
- Amgen's Eylea biosimilar has been approved for Phase III
- by Lee, Tak-Sun Jul 02, 2020 06:10am
- Amgen is conducting a phase III clinical trial on Eylea biosimilar in Korea. Recently, Samsung Bioepis' Eylea biosimilar has also been approved for phase III clinical trials in Korea, so the Korean market is expected to face strong competition between Big Pharma and native biosimilar companies. On the 29th of last month, the MFDS approved a multi-national clinical trial phase III for 'ABP-938' by Korea Parexel. An Eylea biosimilar, ABP-938 is being developed by Amgen. This is a randomized, double-blind, phase III clinical trial comparing the effectiveness and safety of ABP938 and Eylea (Aflibercept) in subjects with wet age-related macular degeneration. A total of 566 people from various countries will participate, and 50 people will be recruited in Korea. Clinical trials will be conducted at SMC, SNUH, AMC, Seoul St. Mary’s hospital, and Korea University Anam Hospital. Eylea, along with Lucentis, is the world's most used treatment for macular degeneration, licensed in March 2013. Based on IQVIA, last year's sales amount was ₩46.8 billion. Competition for the development of biosimilars is intensifying as patents expire in the US this year. Samsung Bioepis, SCD Pharm, and Alteogen are developing as domestic pharmaceutical companies, and Amgen and Mylan have entered the development competition as US companies. As a domestic clinical trial, Samsung Bioepis' biosimilar was approved for phase III on the 11th of last month along with Amgen. Alteogen is undergoing clinical trial phase I in May last year. SCD Pharm announced in May that it had been approved for phase III clinical trial by the US FDA. It is expected that sales competition will intensify as Big pharma such as Amgen have recently entered the development of biosimilars.
