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- 2025-12-23 23:22:37
- 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."
- Policy
- KDCA on cost-effectiveness of expanding HPV vaccination
- by Lee, Tak-Sun Mar 02, 2021 06:25am
- HPV vaccine ‘Gardasil 9’ The government is apparently conducting a study on the cost-effectiveness of expanding the human papillomavirus (HPV) vaccination subject and vaccine types. The outcome of the research could affect the pharmaceutical industry. On Feb. 24, the Korea Disease Control and Prevention Agency (KDCA) official answered Democratic Party Lawmaker Choi Hye-young asking about the agency’s clear stance on the expansion of HPV vaccination subject, as a part of the low birthrate and aging society responding master plan, and said a relevant research is ongoing at the moment. KDCA official elaborated, “The Fourth Low Birthrate and Aging Society Responding Master Plan states the government would review the effectiveness of expanding the HPV vaccination subject from female adolescents alone to both female and male adolescents and switching the quality vaccine targeting two to four types of HPV to nine types. Based on the result of the consignment research in progress, the government agency would consider expanding the vaccination subject.” The ongoing research, running from May last year to coming May, would decide the prioritized order of the national vaccination subject and related mid to long-term plan. And another follow-up research, running from last January to December next year, would analyze the cost-effectiveness in expanding the national HPV vaccination. The KDCA official said, “The government would comprehensively evaluate the result of the policy research regarding the unique quality of the disease, the vaccine’s preventive efficacy against the disease and cost-effectiveness to decide the prioritized order of the vaccination from a public healthcare perspective.” Currently, HPV vaccines like Gardasil and Cervarix are supplied in South Korea. The government’s decision to expand the vaccination subject and vaccine type could positively affect the relevant companies.
- Policy
- The MFDS released the minutes of the Advisory Meeting
- by Lee, Tak-Sun Mar 02, 2021 06:25am
- The Central Pharmaceutical Affairs Review Committee, a legal advisory body of the MFDS, also found that there was a controversy over the AstraZeneca (AZ) COVID-19 vaccine, which has been delayed for vaccination for 65-year-olds. It is administered to adults over the age of 18, including those over 65, but there was an opinion that the elderly should specify that "the vaccination should be carefully decided" in the precautions for use. However, no conclusions were drawn, including the recommendation of the MFDS’ Vaccination Committee to discuss whether to be vaccinated at the age of 65. The MFDS released the minutes of the Advisory Meeting of the Central Pharmaceutical Affairs Review Committee on the approval of the AZ COVDI-19 vaccine on the 4th. The AZ COVDI-19 vaccine was approved for vaccinations over the age of 18, subject to future US clinical data submission as advised by the Central Pharmaceutical Affairs Review Committee on the 10th. However, it stated in the precautions for use that the use for the elderly over the age of 65 should be carefully decided. It was the reason for the lack of clinical data if limited to 65 years of age or older. In addition to the efficacy and effect, which are the most important paragraphs in the permit, the indication was set to be 18 years or older, so that the elderly 65 years or older can also be included. The Central Pharmaceutical Affairs Review Committee also debated whether or not to allow vaccinations for seniors over 65 years of age. The majority opinion was that the vaccine should be made available to people over 65. One member said, "The supply of other vaccines may not be available because the supply timeline of other vaccines is tight. It should be allowed to reduce concerns about severe morbidity in the elderly." Another member also said, "Pregnant women are limited, but for people over 65 years of age, limiting as a matter of effectiveness should be considered differently." He said, "In consideration of the vaccine supply, it would be better to allow it to be 18 years of age or older, and that the effect may be inferior to 65 years of age or older. But there were also objections. One member argued that "the vaccine is not approved because it has a good immune response, and the effect in the elderly is unknown." He added that it is necessary to include restrictions on the use of 65 years of age or older. Another member argued, "It is reasonable to wait for the results of the US clinical trial, not to deny that there is a benefit to the patient, but to consider the impact of the US clinical trial results." At this meeting, it was not easy to gather opinions on whether or not to be vaccinated over the age of 65. When the first agenda was discussed, when a single proposal was not prepared, other agendas were discussed and discussed again. Eventually, the chairman made a single proposal, stating that "there was a considerable compromise of opinions" and "let's give the elderly an opportunity to use it." However, One member also said, "It's different from saying that people over 65 are not recommended until there is additional evidence." In addition, there was an opinion that amendment was proposed as "there is insufficient data on the effect, so it must be carefully determined until the effectiveness is verified." In response, the MFDS argued that "until the effectiveness is verified" may require additional explanation as to whether the effectiveness has not been verified." An official from AZ said, "It was conducted according to the clinical trial plan, and it is judged that it showed safety and efficacy in research subjects including 65 years or older." "The results of the analysis of US data are expected to be released at the end of April, and the efficacy data for the elderly in the UK is 55%, and the P-value is similar to that of young adults with a P-value of 0.005, and is being monitored by UK regulators." Regarding the additive and chimpanzee adenovirus controversy, "Polysorbate 80 is an additive used in other vaccines and has a good safety profile," he said. "The PEG used in mRNA vaccines was associated with anaphylaxis reactions." He said, "The chimpanzee adenovirus was strategically selected for a virus that has not been immune to existing immunity, and it was evaluated on a large scale in other clinical trials such as tuberculosis, Ebola, HIV, and malaria vaccines, and there was no safety concern."
- Policy
- The MFDS is pre-reviewing a combination of Mifegyne
- by Lee, Jeong-Hwan Feb 25, 2021 06:23am
- The MFDS announced that it is in the process of applying for a preliminary review of the combination drug Mifepristone(generic for Mifegyne) and Misoprostol. The MFDS has also initiated a guideline for safe use of abortion pill and is also planning to collect opinions from experts such as gynecologists and women's groups. On the 24th, the MFDS made this announcement in a written inquiry by Nam In-soon, a member of Democratic Party of Korea and the National Assembly's Health and Welfare Committee. She inquired about the current status of domestic screening along with the efficacy and safety of Mifegyne in use in 74 countries around the world. The MFDS replied that it is being used after individual safety and efficacy evaluations along with each country's health care environment. The MFDS announced that it is confirming the application for a preliminary review of Mifepristone & Misoprostol. In other words, some domestic pharmaceutical companies are preparing for marketing permission for abortion pills. Preliminary review is a system in which the standards for preparing data required for drug marketing approval are reviewed in advance prior to formal marketing approval. All of the Mifepristone·Misoprostol combination drugs that have been requested for preliminary review are drugs used overseas as abortion pills. Mifepristone, generic for Mifegyne, is a drug that prevents fetal growth. Many foreign countries are using it, but it was not imported into Korea. Misoprostol induces uterine excretion, and is used in the treatment of gastric duodenitis in Korea. It means that in order to use it as an abortion pill in Korea, it is necessary to expand the indications to change the permission matters such as indications and dosage. The MFDS announced that it has also begun to establish guidelines for safe use of abortion pill. In addition, the MFDS said that it would prepare abortion pill-related policies through a procedure for collecting opinions from experts in various fields such as obstetricians, gynecologists and women's organizations. By referring to overseas prescription cases, even if they are not obstetricians, it is expected that doctors who have completed certain training can prescribe prescriptions. The MFDS said, "We have initiated a preliminary review of Mifepristone·Misoprostol. We will also prepare guidelines for safe use. We will thoroughly verify the safety and effectiveness of the product so that the drug can be used based on the doctor's accurate diagnosis." The MFDS said, "If there is a request for an evaluation to expand the indications of Misoprostol, we will conduct safety and efficacy evaluations." It added, "When establishing related policies with abortion pills, we will consider a plan to expand accessibility together with safety."
