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- 2025-12-23 23:28:48
- 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pharmaceutical companies challenged the patent through a trial to invalidate the extension of the term, but it was withdrawn or invalidated.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.
- Policy
- Paclitaxel + Carboplatin + RT will be reimbursed
- by Lee, Hye-Kyung Jan 21, 2021 06:13am
- Paclitaxel+Carboplatin+RTprior chemotherapy, which required prior approval from the Director of the HIRA, will be reimbursed for anticancer therapy The HIRA announced that it plans to announce an amendment to the announcement of drugs prescribed/administered to cancer patients containing the above contents, and that opinion inquiry will be conducted by the 26th. In the case of resectable esophageal and marginal cancer, in order to receive Paclitaxel+Carboplatin+RT, a prior chemotherapy regimen, the medical institution had to submit an application for exceeding the scope of product approval to the HIRA. However, as a result of side effects evaluation for patients who used the same therapy as exceeding the scope of product approval, safety and clinical usefulness are recognized, so it is decided to recognize the same benefits as the alternative therapy Capecitabine + Cisplatin + CCRT. It was set to 5 cycles according to the clinical practice guidelines. The standards for reimbursement of anticancer drugs used for ovarian cancer have also been partially changed. for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: a deleterious or suspected deleterious BRCA mutation, or Genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy, Zejula, among monotherapy, changed the target of maintenance therapy and added therapy. Regarding maintenance therapy, there was a significant difference in progression-free survival in the clinical trial (NOVA) non-gBRCA patient group, but the NCCN guidelines prioritize the same therapy for BRCA mutant patients, and the sBRCA mutant group among non-gBRCA patients decided to recognize the benefit only for somatic BRCA patients, considering the clinical characteristics and effects similar to those of the gBRCA mutant group. It is recognized only for patients with BRCA mutation in consideration of the high demand for unmet medical care for new drugs that show sufficient effects in indications as a result of review of textbooks and guidelines regarding treatment regimens, and histological classification of patients subject to clinical trials. It was limited to highly serous ovarian cancer for reference.
- Policy
- Conditional approval on Celltrion COVID-19 treatment advised
- by Lee, Tak-Sun Jan 20, 2021 06:02am
- The South Korean health authority’s panel of experts verified the clinical results and advised an approval of Celltrion’s COVID-19 monoclonal antibody treatment candidate Rekirona with a condition to conduct Phase III trial. The panel recommended the drug to be used to alleviate the mild to moderate COVID-19 symptoms in adult patients. The Ministry of Food and Drug Safety (MFDS) stated a meeting for the advisory panel to verify the safety and efficacy in COVID-19 treatment and vaccine candidate was convened on Jan. 17 to discuss about the clinical results of Celltrion’s antibody treatment Rekirona. Prior to the consultation with the Central Pharmaceutical Affairs Deliberation Committee, the advisory panel was gathered to provide advice on clinical and non-clinical drugs and quality. The panel meeting consisted of eight external experts including infectious disease specialist, virologist, clinical statistic expert and other clinical trial experts, and four members from the Review Team and Clinical Trial Evaluation Team under MFDS COVID-19 Treatment Approval Evaluation Team. The advisory panel provided their assessment on the Rekirona injection’s clinical trial outcome to confirm the treatment’s efficacy and safety. The clinical efficacy was evaluated by how fast a patient recovers from seven COVID-19 symptoms (fever, coughing, shortness of breath, sore throat, muscle ache, fatigue and headache) after receiving the candidate treatment. The pharmaceutical mechanism was evaluated by timing how fast a patient’s viral test result change from positive to negative. Advisory panel “Shortened symptom alleviation time clinically meaningful" The trial participants either took the drug or a placebo twice-daily, when they expressed any one of the COVID-19 symptoms at a high or medium level. The researchers measured the time to alleviate or weaken all of their symptoms, after monitoring them until Day 14. As a result, the patients administered with the investigational drug took 5.34 days to recover from the COVID-19 symptoms, when the patients administered with a placebo took 8.77 days. The drug was confirmed to reduce the time to alleviate the COVID-19 symptoms by approximately 3.43 days. The panel judged the clinical outcome is meaningful as it statistically proved the drug could lessen the time to improve the COVID-19 symptoms. The trial also tested the participants who have received the treatment for the change in the viral load to verify the mechanism of preventing the viral infection in a human body by letting the drug to bind with the novel virus instead of a human body cell. The virus test confirmed there is no significant difference between the drug-administered group and the control group with the duration of time the test result change from positive to negative. Although the shortened duration was not statistically meaningful, the panel claimed the administration of the drug seemed to show a tendency to decrease the viral load. Recommends conditional approval, but needs sufficient Phase III evidence To confirm the safety of the drug, the researchers monitored the administered participants until Day 28 to observe adverse reaction and any internal infusion related reaction for its frequency, type and severity. In the end, the type of adverse reactions like hypertriglyceridemia and hypercalcemia were predictable as they were reported from Phase I trial already. The majority of the cases were mild or moderate, and the rate was similar to that of the control group. None of life-threatening case was reported. Overall, the advisory panel recommended approving Rekirona, with a condition to conduct a Phase III trial, but also they laid down a few advices on the product’s efficacy and effect; the treatment clinically demonstrated alleviating mild to moderate COVID-19 symptoms in adult patients aged 18 and over, who does not require supplementary oxygenation, but showed the symptoms within seven days of the injection. The advisory panel demanded the South Korean company to conduct a Phase III to verify meaningful decrease in the disease progression from mild-to-moderate to severe in sufficient number of patients, and to set a detailed guideline for the use in the clinical scene by discussing it with the government separately. Also, the panel advised the company to conduct another trial to verify the combination of the treatment candidate and other severe symptom treatment or an immunomodulator to be used on patients who needs supplementary oxygenation. MFDS plans to utilize the panel’s advices, recommended efficacy and effect and indication and outstanding evidence material to review the investigation drug, and to seek for advices on safety, efficacy and pre-approval consideration from the Central Pharmaceutical Affairs Deliberation Committee, a legal advisory panel under MFDS.
- Policy
- Yuhan's Lazertinib was approved
- by Lee, Tak-Sun Jan 20, 2021 06:02am
- The new drug Lazertinib developed by Yuhan for the treatment of non-small cell lung cancer has obtained approval from the MFDS. The technology was transferred to the global pharmaceutical company Janssen and is currently undergoing licensing procedures in other countries such as the United States. It is the first country in the world to obtain approval from the FDA. The MFDS announced on the 18th that it has approved Yuhan's non-small cell lung cancer treatment Leclaza (Lazertinib mesylate) as the 31st new drug developed in Korea. Leclaza is used in patients with advanced lung cancer with specific gene mutations who have previously been treated for lung cancer. It is a target anticancer drug that inhibits the proliferation and growth of lung cancer cells by interfering with the signal transmission involved in lung cancer cell growth, and is less toxic to normal cells. The drug treats patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer who have previously been treated with EGFR-TKI. It selectively inhibits the epithelial cell growth factor receptor Tyrosine Kinase, which is involved in the growth, differentiation, and survival of cancer cells, and prevents cancer cell survival, proliferation and metastasis. Yuhan applied to conduct a phase III clinical trial after marketing based on the results of a phase II clinical trial conducted in Korea. The MFDS explained that the quality, safety and effectiveness, and post-marketing safety management plans were scientifically reviewed and evaluated according to the review criteria of the Pharmaceutical Affairs Law. The Central Pharmaceutical Affairs Review Committee, which includes experts treating lung cancer in the medical field, gave the final approval after consulting on the completion of the license and conformity to the system. The MFDS said that the approval of the new drug is expected to expand the range of drug options for the treatment of patients with recurrent non-small cell lung cancer. It emphasized that it will continue to provide scientific and thorough approvals and reviews, and by securing objectivity and transparency through expert advice, to ensure that the safety and effectiveness of treatments are sufficiently verified.
