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- 2025-12-25 13:58:17
- Policy
- Special authorization requested for COVAX-Pfizer vaccine
- by Kim, Jung-Ju Feb 05, 2021 05:50am
- The South Korean disease control authority is requesting the health authority to grant a special approval on 117,000 doses of Pfizer vaccines to be supplied to the country by COVAX Facility. Under the supply agreement with COVAX Facility, the vaccines would be promptly introduced to South Korea for inoculation starting from this month. On February 2, Korea Disease Control and Prevention Agency (KDCA) announced it applied for a special import authorization to the Ministry of Food and Drug Safety (MFDS) for the vaccines. The action is based on the results of the COVID-19 Vaccine Expert Council meeting convened by MFDS and KDCA and the Article 85 of the Pharmaceutical Affairs Act. In accordance to the Pharmaceutical Affairs Act, manufacturing and importing preventive drug or treatments without market authorization in South Korea may be possible as requested by a head of related ministry and agency amid pandemic or state emergency. Previously at the council meeting, the experts agreed on the need of special import authorization of COVAX Facility-supplied Pfizer vaccine considering WHO and the U.S. Food and Drug Administration (FDA) have approved of it and also as South Korea’s MFDS has participated in the collaborative review by WHO safety, efficacy and quality evaluation. MFDS accepted KDCA’s special import authorization application on Feb. 2, so the agency could ink the supply contract with Pfizer to immediately bring in the vaccine as soon as the ministry’s authorization is granted. Also the administrative procedure related to UNICEF shipping contract and customs clearance would be processed promptly as well. KDCA official said, “We would fully prepare all processes to initiate the inoculation as soon as the vaccines arrive in South Korea.”
- Policy
- The approval of Atozet’s generics was also difficult
- by Lee, Tak-Sun Feb 04, 2021 06:09am
- It has become difficult for generic companies of MSD's hyperlipidemia complex Atozet to approve items in January. If the approval was obtained in January, the drug for data-based re-evaluation commissioned by Chong Kun Dang and the timing of the registration were the same, so that within 20 drugs could be applied. However, it is known that the time of completion was held in early March, and drug price cuts due to the cascade system became inevitable. According to the industry on the 3rd, generics for Atozet, which had completed the preliminary review, was applied for permission on January 23, the day after the end of PMS. Accordingly, it is known that some companies expected to complete the approval in January. This is because most items have already been reviewed through preliminary review. An official from a pharmaceutical company said, "Since there was an examination period of about 5 days after the 23rd, I was hoping. However, the time was short and since several companies applied, it was difficult to obtain approval in January from the standpoint of equity." If it was approved in January, it was possible to apply the drug price standard of up to 20 same active ingredients. This is because Chong Kun Dang's Drug for data-based re-evaluation was approved on the 8th. Drugs that apply for benefits for the same month are recognized in the same order. Generics for Atozet applied a working day on the 25th, and it was reported that the completion time of the permit review was set in early March. Another pharmaceutical company official said, "Through a preliminary review, we have completed the review of safety, effectiveness, standards and test methods, but if there is no supplementation by applying Working Day according to the existing regulations, the review will be completed in early March." He also said, "It was impossible to get approval in January." With 24 Generics for Atozet, generics licensed after February are subject to a stepped drug price, which is about 15% lower than the existing lowest price. Compared to the already approved Chong Kun Dang products and their consignment products, the launch time is also slow.
- Policy
- Re-evaluation of benefits, scheduled to be conducted annuall
- by Kim, Jung-Ju Feb 03, 2021 06:09am
- At the end of last year, the government is about to begin the main evaluation of the five active ingredients following the pilot project of reevaluation of the adequacy of registered drugs for Choline alfoscerate (reevaluation of the benefits of registered drugs). It seems to have taken into account the time taken for the procedure, such as review and re-evaluation, review of the Pharmaceutical Benefits Advisory Committee, and report to the Health Insurance Policy Review Committee. The government (insurer) plans to prepare a system for recovering drug costs for damages in the first half of the first half of the first half of the year in relation to the increase in administrative litigation, which has become more controversial due to the suspension of execution of choline alfoscerate. Yang Yoon-seok, head of the health insurance department of the Ministry of Health and Welfare, reported the reevaluation plan as a negative agenda at the 2nd plenary meeting of the 2021 the Health Insurance Policy Review Committeeon the afternoon of the 29th, and then met with the Korea Special Press Association to explain the government's position. He said, "I know the pharmaceutical bio industry is struggling with the re-evaluation of registered drug benefits," and "It will be conducted on an annual basis, but in the long term, we are also seeking a plan to evaluate it every 4 to 5 years (regularly). " The following is the contents of questions and answers with Yang. ▶ It is understood that it reported to the Health Insurance Policy Review Committee that a plan to compensate for financial losses due to suspension of execution was prepared in the first half of the year. Please explain this. “The government is aware of the problem of benefits due to the suspension of execution. Last year, the National Assembly also pointed out this issue. Measures to improve the system (which allow the reimbursement of drug costs, etc. paid during the suspension of execution) is being reviewed internally. We are not in the process of making any specific disclosures yet.” ▶ The contract to redeem the Choline alfoscerate drug has not been negotiated since 56 pharmaceutical companies filed lawsuits. The deadline is until the 10th of this month, are there any plans to extend the negotiation deadline in consideration of the litigation situation? "The negotiation period has not been completed yet. I think the NHIS will proceed with the negotiations as much as possible within the deadline. It will report the status of the negotiations after the negotiation period is over, and I will review the details and review again. " ▶ If the system is improved, is it a premise to amend the law? "Improving the system doesn't mean amendment of the law." ▶ Last year, the NHIS conducted a research on this. Do you proceed based on the result? "I'll refer to that, but how to actually legislate is a matter for the government to review and decide." ▶ Does it mean to proceed with government legislation? "The form of legislation has not yet been decided." ▶ This is a question about the reevaluation of the five ingredients that will be notified to the pharmaceutical company this month. The re-evaluation plan has been reported to the committee, please tell me the direction of the future. "It seems that the third quarter will have to go through the process of re-evaluating all five ingredients. Eventually, the re-evaluation will not be able to proceed in an annual cycle. Therefore, it can be considered that the process is being carried out in an annual plan." ▶ Do you have anything else to comment? "Last year, I had a lot of motivation and ambition as the head of the insurance drug department, but I had a lot of difficulties with COVID-19. Re-evaluation of benefits would be an inconvenient issue for the pharmaceutical industry. However, when applying benefits, it is correct to provide effective medicines to the public when applying benefits. Although it is currently undergoing annual evaluation, it is also seeking a plan for a long-term evaluation for the next four to five years, and a series of lawsuits filed by companies are guaranteed rights under the constitution, that's why a full legal review will be needed for the (under review) redemption bill."
- Policy
- Samyang Biopharm started to develop generic for Votrient
- by Lee, Tak-Sun Feb 02, 2021 06:25am
- It was found that a domestic pharmaceutical company started developing Votrient’s generic for Novartis' blockbuster kidney cancer treatment. Generic for Votrient is attracting attention in that there are no commercialized items yet. The MFDS approved the bioequivalence test protocol of Samyang Biopharm’s SYO-1987 on the 28th of last month. Samyang Biopharm is expected to demonstrate equivalence with Novartis' reference drug in a bioequivalence study. This reference drug is used for ▲progressive renal cell carcinoma, and ▲progressive soft tissue sarcoma (the efficacy and safety of this drug in patients with liposarcoma or gastrointestinal stromal tumors have not been proven) previously administered chemotherapy. The drug with this indication is Novartis Korea's Votrient (Pazopanib), a kidney cancer treatment approved by GSK in Korea in 2010, and Novartis owns the copyright as GSK's anticancer drug was sold to Novartis. Advanced kidney cancer treatment is a drug that competes with existing Sutene (Sunitinib, Pfizer) and has become a blockbuster. according to IQVIA, the sales amount in 2019 was ₩13.2 billion, and in the first half of last year, it recorded ₩6.7 billion. Votrient's re-examination expired in August 2016, and the patent is also expected to end on July 24, 2022. With the introduction of generic exclusivity in 2015, domestic pharmaceutical companies challenged the patent through a trial to invalidate the extension of the term, but it was withdrawn or invalidated. This is because they challenged without a strategy. Since then, there has been no news about the development of generics. Samyang Biopharm is a company that focuses on localizing anticancer drugs, and also owns blockbuster products such as Genexol (Paclitaxel). When a generic for Votrient is developed, it is expected to be supplied at a lower price, reducing the economic burden on patients.
- Policy
- Administration of AZ vaccine to the elderly is appropriate
- by Lee, Tak-Sun Feb 02, 2021 06:25am
- The MFDS’ verification advisory group composed of domestic experts presented an opinion that there was no reason to exclude the administration of AstraZeneca's COVID-19 vaccine to the elderly. In addition, it was evaluated that the inoculation was performed twice at the standard dose, and the inoculation interval was appropriate for 4 to 12 weeks. The verification advisory group held a meeting on the 31st of last month and made such a decision on AstraZeneca's COVID-19 vaccine. Many experts who participated in the verification advisory group said that ▲the clinical trial plan was designed to confirm the efficacy and safety in subjects over 18 years old, ▲the prevention effect was confirmed in all subjects including 65 years or older, ▲immune response after vaccine administration considering the similarities with these adults and ▲having a good safety profile, it was revealed that administration to the elderly could not be excluded just because the number of elderly people among the participants was small. However, the preventive effect was not proven due to insufficient data on the high-risk elderly, and that the seroconversion rate in immunogenicity was not different from that of adults, but the antibody titer was lower than that of adults under the age of 65. In addition, they suggested that the correlation between immunogenic response and preventive effect is not established, so it is desirable to reflect additional results such as clinical trials. It was judged appropriate to administer the standard dose, two times, in the planned clinical trial. The advisory group said that ▲the planned dose in the clinical trial was the standard dose, ▲the first administration in the low-dose group and the standard-dose group had a higher preventive effect in the standard-dose group, and ▲the dose interval between the low-dose group and the standard-dose group was not appropriate to simply compare the preventive effects due to the different backs, and ▲the reason was that the comparison between groups was limited due to the small number of subjects in the low-dose group. As for the vaccine administration interval, the opinion was that 4-12 weeks were appropriate as requested by the company. The evidence was that the effect lasted up to 12 weeks after the first vaccination, and the effect was confirmed when administered for 4 to 12 weeks in a major clinical trial conducted in Brazil. However, it was recommended that it is necessary to present specific guidelines for administration intervals after approval in the clinical field after consulting with experts. The MFDS synthesizes expert opinions, efficacy, effects, and recommendations obtained through this verification advisory meeting, as well as the review results, to determine the safety, effectiveness, and safety of the applied items, including the use of the elderly in situations where clinical data for the elderly are limited. It announced that it plans to receive advice from the Central Pharmaceutical Affairs Review Committee on the 4th on matters that need to be considered during approval. Results of the Central Pharmaceutical Affairs Review Committee will be released on the same day. On the 5th, a final review committee for Celltrion's COVID-19 treatment CT-P59 will be held, and it is planned to make a final decision at this meeting.
- Policy
- Clinical data for the elderly for the AZ vaccine are lacking
- by Kim, Jung-Ju Feb 01, 2021 11:52pm
- The detailed schedule and plan for vaccination in Korea was announced, and a limited vaccination discussion continues overseas due to the lack of clinical data for AstraZeneca (AZ)'s COVID-19 vaccine, and the results of the review by licensing authorities are drawing attention later. The MFDS will take all these into account and conduct a statistical review, but will review all the data inferring the effectiveness of the company to determine the final approval. Sang-Bong Kim, Director of Bio-Pharmaceutical Bureau of the MFDS explained this through a regular briefing of COVID-19 during the day on the 28th. Currently, the MFDS is in the process of reviewing as AZ applied for COVID-19 vaccine approval. However, due to the lack of clinical data on the elderly, the company and Germany are also aware of this, and talks about vaccination plans for young people are also coming out. When applying in Korea, AZ also submitted data stating that dose adjustments are not necessary for the young and the elderly, data from clinical trials in the UK and Brazil, and some of the data submitted to the EU licensing authority. Director Sang-Bong Kim said, “The vaccine safety and effectiveness verification advisory group, the Central Pharmaceutical Affairs Review Committee, and the final review committee will thoroughly review when limiting clinical subjects to the elderly. and in the currently submitted clinical results data, the number of elderly clinical investigators is insufficient, so a statistical review is necessary." The MFDS is planning to review and verify the effect inference as well as the immunogenicity data that AZ submitted at the time of EU approval application was submitted to the MFDS. In the case of AZ products, the COVAX facility will collect the amount and timing of supply around the world and notify each country in the future, so the quarantine authorities plan to determine the inoculation plan by reflecting this schedule.
- Policy
- Can COVID-19 vaccine by the COVAX be quickly introduced?
- by Lee, Tak-Sun Jan 27, 2021 06:15am
- COVID-19 vaccine developed by PfizerThe health authorities said that it is possible to quickly introduce COVID-19 vaccine supplied from the COVAX Facility. This is because the MFDS has been participating in the COVAX Facility vaccine joint review since October at the request of the WHO. Pfizer's vaccine was pre-verified on the 31st of last month when the WHO approved Emergency Use Authorization. This is why the government believes that rapid vaccination is possible by receiving the Pfizer vaccine from the COVAX Facility in early February. The MFDS announced in a report from the President on the 25th that it is participating in the joint review of the COVAX Facility’s COVID-19 vaccine at the request of the WHO in October. Pfizer's mRNA vaccine has been reviewed, and 13 items will be reviewed. In fact, on the 31st of last month, the WHO Emergency Use Authorization of the Pfizer vaccine. On the 22nd, it also signed a contract for 40 million doses of Pfizer vaccine for the use of the COVAX Facility. It is expected to be supplied to member countries that have joined the COVAX Facility from February. The case of Korea is also being discussed. Current status of the MFDS Korea has signed a vaccine supply contract for a total of 1,000 people with COVAX Facility. Among them, 50,000 Pfizer’s vaccines are expected to be introduced first in early February. However, Pfizer’s vaccine has not been approved in Korea, so it is possible to introduce it in an emergency only through special imports. Until now, special imports have been mainly applied to small amounts of imported products such as orphan drugs and essential drugs. However, last year's COVID-19 treatment 'Remdesivir' could be introduced urgently due to an infectious disease. However, it is said that it is impossible to apply special imports for imported vaccines that do not have domestic clinical cases or screening history. In response, the MFDS explained that vaccines supplied from the COVAX Facility can be considered for special imports because Korean examiners participated in the joint review. An official from the MFDS said, “In the case of vaccines supplied through the WHO, examiners of the MFDS have participated in the quality certification evaluation. At the request of WHO, we have been participating in the WHO quality certification evaluation of COVID-19 vaccine since last October. Because I participated in the review, it will be used as a reference when deciding on special import.” It is explained that this situation was also reflected by the MFDS' description of the WHO joint review situation in the data of the President's report. It is interpreted that if the introduction of COVID-19 vaccine is confirmed by the COVAX Facility in early February, it is highly likely to follow special import procedures. Special import is determined by the KCDA through expert advice, etc. Special import is possible after 3-4 days of procedure. Pfizer's vaccine applied for official approval from the MFDS on the 25th. Since it plans to complete the approval review within 40 days with as early as possible, item approval is expected in early March. The government has signed a contract with Pfizer to bring in COVID-19 vaccine doses for 10 million people of the third quarter.
- Policy
- AZ’s Vaccine Verification Advisory Committee Meeting held
- by Lee, Tak-Sun Jan 27, 2021 02:24am
- An advisory group meeting to verify the safety and effectiveness of AstraZeneca's COVID-19 vaccine will be held on the 31st of this month. In this meeting, external experts will participate in the clinical trial data. In addition, the Central Pharmaceutical Affairs Review Committee for COVID-19 treatment developed by Celltrion will be held on the 27th, and the results will be released on the same day. The MFDS announced on the 21st the progress of COVID-19 vaccine and treatment review process. Completed the survey on the actual condition of the SK Bioscience factory. Request for quality data and review for lot release According to the MFDS, the AstraZeneca’s COVID-19 vaccine completed a factory site survey for SK Bioscience from the 18th to the 20th. Currently, non-clinical and clinical trial data and quality data are being reviewed. The vaccination group and the placebo group are compared and reviewed if there is any safety information that requires special attention in the elderly over 65 years of age. In the factory condition survey of SK Bioscience, as it is a virus vector vaccine, the management of genetically modified organisms in the factory and the management of the biosafety level (BSL) were confirmed. It is explained that the area manufactured with sterile injections has facilities and environments that can prevent contamination from fine particles and microorganisms, and that it has maintained the specified cleanliness level. The MFDS requested additional data necessary for screening, such as non-clinical, clinical, and quality, on the 15th, and as soon as the data are submitted, it reviews the preventive effect, the validity of the application and dosage, and safety, and the quality for national lot release. In particular, COVID-19 Vaccine Safety and Effectiveness Verification Advisory Group' meeting, in which external experts participate in the clinical trial data, will be held on the 31st of this month, and the results will be released on February 1, the next day. Celltrion's Regdanvimab screening is on the way. The Central Pharmaceutical Affairs Review Committee is likely to recommend approval this month For the COVID-19 treatment Celltrion's Regdanvimab, it has completed an investigation into the factory and clinical trial institutions, and is currently undergoing additional review and review of quality data for non-clinical and clinical trial data.The request for data submission including some of the quality data that has not yet been submitted was requested on the 20th, and the review will proceed as soon as it is submitted. The review results will be summarized and consulted on the safety, effectiveness, and matters to be considered during approval from the Central Pharmaceutical Affairs Review Committee, a legal advisory body of the MFDS, and the results will be disclosed on the same day. After that, the final inspection committee is held once to decide on item approval.
- Policy
- Nexavar's price drops by 30% & Teribone inj ↑31%
- by Kim, Jung-Ju Jan 25, 2021 06:22am
- The price of Bayer Korea's anticancer drug Nexavar 200mg (Sorafenib tosylate) will be reduced by 30% next month. It is a government control. After that, at the end of the year, the benefits that have been given the premium will end and fall further. The price of Dong-A ST's postmenopausal osteoporosis treatment Teribone inj 56.5μg (teriparatide) will rise by nearly 31% by the beginning of 2021. According to industry sources on the 21st, the MOHW is pushing ahead with the revision of the 'pharmaceutical benefit list and upper limit price table'. The actual application date differs for each item. ◆ End of addition = addition of Bayer Korea's Nexavar 200mg ends next month and the drug price drops by 30% The government has added 70% of the first listed products for one year from the date of the first generic registration, and then the addition is terminated. However, even if one year has elapsed, if the number of companies for the same product is less than 3, the addition is maintained until 4 or more within the maximum range of 5 years. The price to be cut next month will be ￦12,992 from ￦18,560. After that, as the addition ends on December 1, the adjusted price is ￦9,939 from ￦12,992, down 23.5%. ◆Addition of new items = Paricalcitol, a vitamin from Huons, and Cefditoren pivoxil, a cephalosporin antibiotic from Kukje Pharma, will be reduced in price according to the end of the addition The government has given an increase of 59.5% for one year from the date of first generic registration and 68% for innovative pharmaceutical company, and then terminated. The government adds 70% of the product to the product for one year from the date the generic is first listed and then ends the addition. However, even if one year has elapsed, if the number of companies for the same product is less than 3, the addition is maintained until 4 or more within the maximum range of 5 years. Huons' vitamin paricalcitol drops 21.2% from ￦15,309 to ￦12,056 from April 1st, and paricalcitol fine granule drops 9.9% from ￦647 to ￦583 from February 1st of next year. ◆Additional maintenance and termination = Donga ST’s Teribone inj 56.5μg will be added as of next month This is because the government maintains the addition when the number of companies under the same system is less than 3 even though the addition period has elapsed one year. The price is 30.7% higher from the current ￦43,606 won to ￦57,001. The end of the addition is February 1, 2023. If the addition is maintained, the number of companies of the same product is applied until the number of companies of the same product is 3 or less, and when the number of companies of the same product is 4 or more. The 4th~5th year is less than 3 companies, and the extension is decided every year after deliberation. Teribone inj56.5μg insurance price adjusted in 2023 will drop 23.5%.
- Policy
- GemVax dementia drug candidate is reviewed for PSP
- by Lee, Tak-Sun Jan 21, 2021 06:14am
- It is considering clinical trials to verify the new drug candidate GV1001, which GemVax is developing as a treatment for Alzheimer's disease, for the rare disease progressive supranuclear pals. However, the Central Pharmaceutical Affairs Review Committee, an expert advisory body from the MFDS, has postponed the judgment that additional data are needed. The minutes of the Central Pharmaceutical Affairs Review Committee released by the MFDS on the 20th are as follows. The meeting held on the 11th of last month was to consult with GV1001 on the feasibility of conducting a clinical trial for patients with progressive supranuclear pals. GV1001 is a treatment for Alzheimer's disease that GemVax is developing. In Korea, phase II clinical trial have been conducted for moderate patients and are currently pursuing phase III trial. In addition, it has been approved for phase II clinical trial in the US, and is aiming to begin in the first half of this year. GV1001 is the same active ingredient as Riavax, which is licensed as a treatment for pancreatic cancer. It is being developed as a treatment for dementia by changing its use. However, Riavax was canceled in August of last year because it did not meet CMA criteria. According to the minutes of the meeting, the MFDS currently has no cure for progressive supranuclear pals. Given that the applied clinical trial is an Investigator-Sponsored Trial, not a Sponsor-Initiated Trial, it was judged that it was necessary to consider approving a clinical trial protocol if it could help progressive supranuclear pals. Advisors to the Central Pharmaceutical Affairs Review Committee pointed out that there are no animal studies and data on the results of phase II clinical trial for Alzheimer's disease are insufficient. It could be considered by submitting additional data. One member said, "Progressive supranuclear pals themselves are rare, and the speed of progression is so fast that it will be difficult to predict with an animal model. The validity of the dose is a safety issue. If there is data, we can consider approving the clinical trial protocol.” The chairman said, "It is necessary to submit data that can link Alzheimer's disease and progressive supranuclear pals to determine whether to replace the advanced progressive supranuclear pals animal model effect data with the Alzheimer's disease animal model effect data." "Let's review the results of the phase II clinical trial for sick patients." The committee members put emphasis on the fact that the results of phase II clinical trial for Alzheimer's disease are summary data, so it is necessary to review the full report. The MFDS concluded, "We will submit additional data according to the results of the meeting," and concluded that "We will determine whether to replace the effective data after receiving the data to prove the correlation between progressive supranuclear pals and Alzheimer's disease." It added, "We will ask for additional advice if necessary after we have received a report on the results of a phase II clinical trial for patients with Alzheimer's disease and reviewed it by the MFDS." Progressive supranuclear pals are rare diseases that cause degeneration of nerve fibers in the cerebral cortex and subcortical tissues, and cause Parkinson's symptoms such as gait disorders and impaired intelligence. Onset in their 50s to 60s and worsening symptoms lead to death. There is no special treatment and an urgent need for a cure.
