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- 2025-12-25 13:58:17
- Policy
- Soliris follow-on Ultomiris conditionally listed
- by Lee, Hye-Kyung Mar 09, 2021 06:24am
- Handok’s paroxymal nocturnal hemoglobinuria (PNH) treatment Ultomiris (ravulizumab) is getting closer to the National Health Insurance (NHI) reimbursement. On Mar. 4, the Health Insurance Review and Assessment Service (HIRA) convened a second meeting of the year for the Drug Reimbursement Evaluation Committee (DREC) and deliberated listing six items, such as Ultomiris, Sanofi-Aventis Korea’s Praluent (alirocumab) pen injection 75 mg and 100 mg, Kuhnil, Penmix, Boryung Pharmaceutical and Yungjin Pharm’s Pentosin (daptomycin) injection 350 mg and 500 mg. As a result, the reimbursement for Praluent injection was cleared, but Ultomiris and Pentosin were conditionally passed, where the companies would have to accept a pricing lower than the evaluated price. Ultomiris shares the same active ingredient with one of the most expensive new drugs Soliris (eculizumab). The follow-on drug was authorized by the U.S. Food and Drug Administration (FDA) in December 2018, and European Medicines Agency (EMA) in July 2018. The South Korean health authority approved of the drug on May 21, 2020. The upper limit pricing on Soliris is at 5,132,364 won per vial (30 ml), costing a patient approximately 400 million won a year for administering three vials biweekly. Meanwhile, Ultomiris administers maintenance load once every eight weeks for two weeks after the initial load. The long interval in administration would help lowering the cost per patient even if it is priced similarly to Soliris. However, Handok would win the reimbursement only if it accepts a pricing lower than the DREC’s evaluated price, as it proposed a pricing higher than what DREC evaluated as. All six items containing daptomycin—either approved as domestically manufactured or imported as a complete product of Cubicin authorized in 2003 by an American-based Cubist Pharmaceuticals in 2003—also applied for the listing but received conditional approval.
- Policy
- GC Pharma-Moderna-KCDC ink COVID-19 vaccine contract
- by Lee, Jeong-Hwan Mar 08, 2021 06:20am
- GC Pharma has officially announced it would supply the COVID-19 vaccine developed by Moderna. The decision is made for the vaccine distribution deal signed between the multinational company and the Korea Disease Control and Prevention Agency (KDCA).. On Mar. 4, GC Pharma (President Heo Eun-cheol) stated it would distribute 40 million doses of an American-based Moderna’s COVID-19 vaccine. The company elaborated the decision was made to support the government’s goal by supplying the vaccine at the right timing, immediately after the South Korean authorization procedure. Previously, KDCA said the 40 million doses of Moderna’s COVID-19 vaccine would be imported to the country from the second quarter. The decision was made based on the contracts signed between GC Pharma and Moderna, and GC Pharma and KDCA. The vaccine developer and the health authority would support GC Pharma in processing the local authorization process and take in charge of the local distribution. President Heo Eun-cheol of GC Pharma commented, “We are proud to be able to cooperate with the government and Moderna to supply the vaccine to the people. As controlling the infectious disease is the top priority task for a pharmaceutical company, GC Pharma is seeking various means to prepare for COVID-19 and other prospective public health emergency based on the capability and experience the company has been accumulating.”
- Policy
- Amivantamab designated as a rare drug
- by Lee, Tak-Sun Mar 08, 2021 06:19am
- Janssen's Amivantamab, which is promoting joint development with Yuhan's non-small cell lung cancer treatment Leclaza, has been newly designated as an orphan drug. The MFDS announced that it will newly designate five drugs, including Amivantamab, as orphan drugs, and announce additional target diseases for three drugs, including 5-Aminolevulinic acid HCl. Orphan drugs are used for the purpose of diagnosing or treating rare diseases. It is a drug that has been designated by the Minister of Food and Drug Safety with no alternative drugs or with improved safety or efficacy than alternative drugs. Amivantamab has been designated as a treatment for non-small cell lung cancer with an epidermal growth factor receptor (EGFR) exon 20 insertion mutation. In order to support the development of treatments for rare and incurable diseases, the MFDS is operating an orphan drug designation system that allows rapid approval of orphan drugs according to the characteristics of the disease. An official from the MFDS said, "The designation of an orphan drug is expected to help in the development of treatments for people with rare and intractable diseases." It said, "We will continue to formulate policies to guarantee patient treatment opportunities in the future."
- Policy
- 1 free dose of rare cancer treatment Lutathera
- by Lee, Tak-Sun Mar 05, 2021 06:25am
- Apparently, South Korea’s Ministry of Food and Drug Safety (MFDS) is to lessen the patient’s financial burden through a patient aid program for a rare cancer treatment Lutathera until it gets officially listed for reimbursement. The government program would grant a free dose of the treatment. MFDS announced the Lutathera patient aid program would run for 12 months as collaborated by Korea Orphan & Essential Drug Center (KOEDC, CEO Kim Nakyung), a foreign drug developer with an Advanced Accelerator Application, and Korea Alliance of Patients Organization (KAPO). Lutathera is indicated to treat patients with neuroendocrine tumor, which costs approximately 100 million won for a single treatment cycle (total four doses). In November 2019, MFDS acknowledged Lutathera as an emergency use drug and it has been supplying the drug with KOEDC. The ministry elaborated the government has been preparing the patient aid program to ensure patients with treatment opportunity by providing support in purchasing the drug and managing the safety. The patient aid program stipulates the foreign drug developer to provide at least one dose of the drug for free to patient, and KODC to give user guide to patient and healthcare provider for safe use and designate a Chief Safety Officer (CSO) to manage individual patient administration record and adverse reaction report. The program would be temporarily available for about 12 months from Mar. 2, but the program would still provide support to access the drug to patients, who participated in the program before the end date, during the planned treatment term. However, depending on the reimbursement listing date for Lutathera licensed by Novartis Korea, the program could end earlier than initially scheduled. Minister of Food and Drug Safety Kim Gang-lip stated, “We expect to grant access to the treatment opportunity to struggling patients with neuroendocrine tumor in South Korea through the patient aid program. The ministry would continue to provide support for the patients in pain fighting against disease to get them the needed treatment access.” For more information on the patient support program, contact and enquire KODC via hotline (02-2219-9815) and email (drugsafety@kodc.ac.kr).
- Policy
- Jardiance generics win approvals one after another
- by Lee, Jeong-Hwan Mar 04, 2021 06:10am
- A series of generics of Boehringer Ingelheim Korea’s antidiabetic sodium-glucose co-transporter-2 (SGLT2) inhibitor Jardiance (empagliflozin) seem to be receiving the market authorization one after another. On Mar. 3, South Korea’s Ministry of Food and Drug Safety (MFDS) authorized Korea Prime Pharm’s Empazin 10 mg and 20 mg tablets. As a result, three South Korean companies—Kukje Pharma, Dongkoo Bio & Pharma and Korea Prime Pharm—have Jardiance generics ready for the market. The health authority green lit Kukje Pharma and Dongkoo Bio & Pharma’s Jardiance generics, Glinace and Empance, on Feb. 24. These were the first Jardiance generics to be approved in the country. Jardiance can be administered as a supplementary to diet and exercise therapies for adult patients with type 2 diabetes to control their blood sugar level. Although the three items have been cleared for marketing, the Jardiance generic cannot be released immediately. The product patent in Jardiance expiring in 2025 has not been challenged successfully. In other words, the approved companies have presumably submitted a patent certification to MFDS that they agree to launch the products after October 2025, when Jardiance patent expires. A company releasing the generic before the patent expiration would be penalized and lose the authorization. The patent expiring on Oct. 23, 2025, ‘the use of and production of glucopyranosyl-substituted benzol derivatives and drug containing the compound,’ has been challenged by Dong-A ST attempting to nullify the patent in 2015, but it was eventually dismissed in 2018. However, 52 South Korean pharmaceutical companies have successfully requested negative confirmation and evaded Jardiance’ crystalline form patent expiring in 2026. Ultimately, the generic makers can either nullify the other patent, or launch the generics after Oct. 23, 2025 after the patent expiration. Similar to Kukje Pharma, Dongkoo Bio & Pharma and Korea Prime Pharm, the other patent-evaded companies would highly likely to seek for the marketing authorization in advance. Pharmaceutical market research data UBIST on outpatient prescription volume found Jardiance has generated 29.2 billion won and 35.4 billion won in 2019 and 2020, respectively.
- Policy
- Single-dose Janssen COVID-19 vaccine requests authorization
- by Lee, Tak-Sun Mar 04, 2021 06:10am
- Janssen’s COVID-19 vaccine to be introduced to South Korea in the second quarter has officially requested for authorization to the Ministry of Food and Drug Safety (MFDS). Following AstraZeneca and Pfizer, the multinational company would be a third company to apply for the authorization on COVID-19 vaccine in the country. On Feb. 27, MFDS official announced Janssen (Johnson & Johnson) has submitted an application for approval on COVID-19 vaccine (code name: Ad26.COV2S). The vaccine was one of a part the South Korean government’s vaccination plan. While AstraZeneca and Pfizer’s vaccines need double doses for a full vaccination, Janssen’s vaccine only requires single dose and the government chose the vaccine for its convenience. Janssen’s vaccine uses the mechanism of a virus vector vaccine, which injects adenovirus via virus vector to human body to generate the antigen in the body inducing the adequate immune response. The same mechanism is used by ‘AstraZeneca Korea Covid-19 Vaccine.’ MFDS stated the submitted quality, non-clinical, clinical and Good Manufacturing Practice (GMP) data would be closely reviewed, and it would decide on the approval based on the COVID-19 safety and efficacy review by the Advisory Panel, Central Pharmaceutical Affairs Deliberation Committee and Final Inspection Committee. Janssen has already gone through preliminary review on the vaccine based on the non-clinical data and quality assurance evidence from Dec. 22, 2020. Meanwhile, the U.S. Food and Drug Administration (FDA) announced its Vaccines and Related Biological Products Advisory Committee (VRBPAC) has granted an emergency use authorization (EUA) for Janssen COVID-19 vaccine on Feb. 26 as a third vaccine to be authorized in the U.S.
- Policy
- How GC Pharma obtained the copyright of Moderna vaccine?
- by Lee, Jeong-Hwan Mar 04, 2021 06:10am
- Moderna signed distribution agreement with GC Pharma for its COVID-19 vaccine in Korea, and GC Pharma has the final copyright. On the 26th, GC Pharma was a successful bidder as a domestic pharmaceutical company in charge of licensing and distribution of Moderna’s mRNA-1273 vaccine. GC Pharma's CEO Eun-cheol Huh bids for ₩34.2 billion. GC Pharma has completed the procedure for approval by the MFDS and national lot release for the domestic market approval of Moderna vaccine in the future. And it will be in charge of supplying 40 million doses of government vaccines. GC Pharma is expected to distribute vaccines sold to the general market in addition to the government's 20 million vaccines through an additional contract with Moderna in the future. GC Pharma is the only domestic pharmaceutical company to win the domestic copyright of Moderna vaccine. How did GC Pharma get the domestic copyright for Moderna vaccine? According to the pharmaceutical and bio-industry, Moderna carefully analyzed the expertise of the MFDS for the distribution of COVID-19 vaccine in Korea, the understanding of the pharmaceutical and bio-industry fields such as mRNA vaccines, and the sales force for the distribution of vaccines. It was evaluated and reviewed the vaccine expertise of domestic pharmaceutical and bio companies including GC Pharma. It is known that GC Pharma has secured Moderna's licensing and distribution rights with its strengths by strongly appealing to the understanding of biologics licensing and maintaining and strengthening the vaccine pipeline since its inception. In particular, there is an evaluation that the reliability of the vaccine field that GC Pharma has built up due to the involvement of a number of government ministries such as Cheongwadae, the MOHW, the MFDS, and the KCDA has influenced the successful bid. The pharmaceutical industry predicts that Moderna will struggle with whether to import the finished product for domestic distribution and consignment production after approval for COVID-19 vaccine. In the case of consignment production of mRNA vaccines in Korea, the transfer of the original technology is inevitable, and there are not many pharmaceutical companies that have sufficiently secured the domestic mRNA production process, so these factors are expected to determine whether Moderna's finished vaccine imports and consignment production. An industry insider said, "Moderna does not mention anything about consignment production while pursuing licensing and domestic distribution contracts. Because the domestic vaccination schedule is not close enough, Moderna may not think about consignment production itself."
- Policy
- Pfizer vaccine can be administered over the age of 16 years
- by Lee, Tak-Sun Mar 03, 2021 06:23am
- The Central Pharmaceutical Affairs Review Committee, an expert advisory body for the MFDS, recommended the approval of Pfizer's COVID-19 vaccine. They gathered opinions that it is possible to administer them even over the age of 16. The MFDS explained the results by announcing the results of the Central Pharmaceutical Affairs Review Committee meeting held on the 25th. This Central Pharmaceutical Affairs Review Committee meeting is held with 19 external experts including 13 standing members of the Biopharmaceutical Subcommittee, which is a specialized subcommittee for deliberation on the safety and effectiveness of vaccines, 5 verification advisory members, and 1 expert recommended by the Korea Medical Association and the MFDS. Eight members, including the general review team, clinical review team, and quality review team of COVID-19 Crisis Response Support Division, attended the vaccine review team. They gathered opinions that item approval is possible when synthesizing the consultation results of the COVID-19 vaccine safety and effectiveness verification advisory group. In particular, based on the preventive effect confirmed in the results of clinical trials involving 16 years of age or older, it was concluded that it is reasonable to approve it for subjects 16 years of age or older like the efficacy and effect. Considering that the immune response of adolescents over 16 years of age is not different from that of adults, and considering the availability of adult clinical trial data, it was found that 'effectiveness and safety in adolescents aged 16 to 17 were extrapolated from the data of adults' in Korea as in the United States. The safety advisory result was an acceptable level for the safety profile, such as adverse events that occurred in clinical trials, but it was an opinion that close monitoring after administration was necessary for people with a history of hypersensitivity, including anaphylaxis. It was recommended that the reported abnormal cases be clearly reflected in the package insert. Based on this opinion, the MFDS announced that it plans to hold a final inspection committee by combining the efficacy and effect, indications and dose, and recommendations to determine whether or not to finalize the approval. The approval is expected to be decided next week.
- Policy
- Will Kymriah be approved?
- by Lee, Tak-Sun Mar 02, 2021 06:25am
- The market approval of Kymriah by Novartis, a commercially available CAR-T (chimeric antigen receptor-T cell) treatment in the domestic market, is imminent. Kymriah is the first CAR-T treatment approved by the US FDA, and it applied for approval in Korea earlier last year. According to the industry on the 1st, Kymriah recently completed the safety and efficacy review by the MFDS, and is about to get item approval. It can be said that a new drug is almost finished after the safety and efficacy review is normally completed. Moreover, Kymriah applied for approval in Korea early last year, and it is a drug that has been reviewed for a long time. By the US FDA, Kymriah was approved as a treatment for refractory or recurrent or acute lymphocytic leukemia (ALL) on August 30, 2017. It is the first CAR-T treatment. CAR-T is a type of cell therapy, and refers to a technology in which T cells extracted from cancer patients are re-injected into patients by expressing specific chimeric antigen receptor (CAR) in cancer cells by using a virus vector. It is in the spotlight as a next-generation anticancer agent in that it selects and kills only cancer cells while minimizing damage to normal cells. The productivity is low and the cost is high. However, the market size is expected to grow to more than $10 billion with good efficacy. Accordingly, ventures such as AbClon and GCCell are conducting commercial development in Korea. Kymriah's listed price is $475,000 (about ₩534.8 million), and in Japan, approved in March 2019, it was listed at ¥33.49 million (about ₩354.41 million). Domestic insurance authorities will be concerned as it is very expensive.
- Policy
- Celltrion abandoned clinical trials of CT-P59
- by Lee, Jeong-Hwan Mar 02, 2021 06:25am
- It was found that Celltrion gave up the clinical trial of CT-P59, a prophylactic antibody treatment to respond to COVID-19. Celltrion decided to suspend the project selection agreement in less than a month after it was selected for the government support project in December of last year. Celltrion cited the difficulty of developing vaccines from global pharmaceutical companies and recruiting patients for clinical trials as a reason for giving up clinical trials. On the 25th, Jeon Bong-min (Independent Representative) made the announcement through the 'COVID-19 treatment/vaccine development project, abandonment of the 2nd selection project agreement in 2020' submitted by the MOHW. In August and November of last year, the government provided a total of ₩31.7 billion for the development of Celltrion antibody treatments. Antibody therapy, which was the first task, has been in use since the 17th with the approval of the MFDS on February 5 this year. In mid-December, less than a month after the second selection project, Celltrion submitted a waiver to the Korea Drug Development Fund. Celltrion cited the difficulty of developing vaccines for global pharmaceutical companies and recruiting participants in clinical trials as reasons for giving up. Jeon Bong-min said, "The government is trying to develop a domestic treatment for COVID-19 with a budget of several hundred billion won, but the treatment for urgently ill patients is not being developed." He said, "The government will have to come up with a more systematic support plan in preparation for the re-proliferation of COVID-19 that there may be more."
