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- 2025-12-24 11:39:48
- Policy
- 26 million flu vaccines will be released this year
- by Lee, Tak-Sun Jun 22, 2020 06:08am
- It is expected that 26 million flu vaccines will be released this year. The MFDS is planning to cooperate closely with the industry in preparation for an increase in demand for inoculation due to the prevalence of COVID-19 and the flu at the same time in the second half of the year. On the 18th, the MFDS announced that it will hold a briefing on the lot release of flu vaccines in 2020 for domestic vaccine manufacturers and importers. The main contents of the briefing are ▲ Amendments to the lot release approval regulations ▲ Precautions when preparing a summary of manufacturing and quality control ▲ Plan for procurement of vaccination for public use. Influenza vaccine planned for domestic distribution in 2020 An official from the MFDS said, "We expect the country's seasonal flu (influenza) vaccine to be approved for the lot release this year at about 26 million. And plans to work closely with the KCDC." The MFDS said that it would pay attention to the condition of COVID-19 ooutbreak, and will promptly approve the lot release so that seasonal flu vaccines can be supplied smoothly, and closely monitor supply and demand in cooperation with the KCDC.
- Policy
- What is the solution for Remdesivir/generic competitiveness?
- by Lee, Tak-Sun Jun 19, 2020 06:21am
- Kim Young-ok, director of pharmaceutical safety bureau at the MFDS There was no communication between the MFDS and the pharmaceutical industry due to the COVID-19 crisis that began in Korea from the end of January. Since the 'Director of pharmaceutical safety bureau at the MFDS-CEO Meeting in 2020' was postponed indefinitely on February 12, the news of the MFDS was only occasionally available through data and articles. The 'Online Video Conference between the MFDS and the factory managers in the pharmaceutical industry' held on the 2nd and 9th attracted attention as it was a place of communication after a long time. The MFDS says it will continue to expand such non-face-to-face video conferencing and investigation. Officially met with reporters this year, Kim Young-ok, director of pharmaceutical safety bureau at the MFDS, also selected keywords of the MFDS as a solution to non-face-to-face environmental changes and generic competitiveness measures after the COVID-19 outbreak. In addition to the reporter's meeting with director Kim Young-ok held on the 16th, there was also a story about the homework facing the MFDS in COVID-19 crisis. These include, for example, special imports of Remdesivir and clinical trials of COVID-19 treatments. The following is a summary of the meeting with Director Kim Young-ok. After COVID-19 incident, how will the factory survey be conducted? "As the non-face-to-face environment becomes common, it is inevitable to change. Some are already doing so. For example, if there is a due diligence report from the PIC/s member countries, it replaces the actual investigation. I'm going to try a method that I can see even if I don't go, and I think I can connect to the company and employees through video equipment to look at facilities, equipment, etc. Korea has good IT technology and networks, If it goes well, I think these things will be enlarged and become everyday." Will the policy briefing sessions proceed in a non-face-to-face manner in the future? "I recently had a videoconference with the factory manager of a pharmaceutical company, and I plan to expand it in the future because it was a place where I could communicate with the field without face-to-face. There are several technical and unfamiliar parts. There are many effective aspects. The policy briefing session is also looking for ways to make it non-face-to-face, and it is also considering ways to post content on Youtube and so on, so that it does not end in one time. Counseling is also being prepared so that the videoconference can proceed as much as possible." In this non-face-to-face situation, can clinical trials of COVID-19 treatment be conducted properly? "The clinical trials for new drug development should also prepare for system maintenance according to non-face-to-face. Change has already begun.. In the case of COVID-19 treatment, it is difficult for clinical trial operators to contact and even obtain consent. The agency has made improvements to ensure that clinical trials can be carried out smoothly. As a result, 12 clinical trials related to COVID-19 treatment and 2 vaccines have been approved." How is the public-private partnership to strengthen the competitiveness of generic drugs? Paradoxically, international confidence in medical products in Korea has been increasing a lot since COVID-19. I think Korean medicine should enter the global market with this opportunity. It is discussing strengthening international competitiveness of generic drugs through public-private councils in this regard. There are two main objectives. The first is to provide accurate information to the people, and the second is to make 'K-Generic' grow into the future industry. In order for these things to work, we need to help them enter the global market. The MFDS is planning to proceed with international cooperation with local governments so that Korean companies can obtain product approvals quickly from overseas countries. The public-private council plans to announce the final conclusion in late June." How is the cause of NDMA detected in Metformin being investigated? “We plan to draw a final conclusion through the NDMA investigation committee. We are investigating with the manufacturer with the detected item. We went through due diligence to understand the situation. When the data is gathered in the committee, it seems that scientific conclusion will be reached. However, it seems difficult to complete the cause investigation within a short period of time because there are various facts (causes) in the process.” How is the discussion of accident compensation due to the NDMA case going on? "This issue is also being discussed through the public-private council. However, I think we should see the lawsuit result in the Valsartan case. I intend to participate if it goes through legislative assembly with regard to personal contributions." How is the proceedings of special import for Remdesivir going? "We are in the process of discussing with Gilead and the KCDC. The timing and quantity of supply will be decided in a consultation process. Gilead is also actively negotiating. These drugs need to be approached in that respect because the company has more publicity than taking private profits. Gilead knows well." Isn’t the reevaluation of Choline alfoscerate formulations too late? “We are going at our own pace. The schedule of the MFDS was in June, and it seems to be going as it was. In the meantime, there were data limitations, and thus, manufacturers were asked for additional data. Some experts reviewed it internally, and some evaluations were conducted by the evaluation agency. Currently, Pharmaceutical Affairs Review Committee’s meeting is scheduled to be held and it will be asked if a special reevaluation is appropriate. If a special reevaluation is conducted, it is planned to seek advice on how appropriate it is. When the results are announced, we will take steps to organize the position of the MFDS and publish it soon. However, the Committee is not a deliberative body, but an advisory body.”
- Policy
- Lee Nak-yeon, would continue to support COVID-19 development
- by Lee, Jeong-Hwan Jun 19, 2020 06:20am
- 민주당 코로나19 국난극복위원회 이낙연 위원장(왼쪽)과 전혜숙 부위원장Chairman Lee Nak-yeon urged the MOHW and the MFDS to fully compensate for the cost of R&D so that domestic COVID-19 vaccines and therapeutics can contribute to the world. On the 17th, Chairman Lee attended the 'One-Health Strategy Debate on Future Infectious Diseases X' hosted by the Democratic Party of Korea’s COVID-19 National Overcoming Committee. Chairman Lee said that even if domestic COVID-19 vaccines and treatments are not developed for the first time in the world, policy support and cost compensation should be sufficiently provided. In particular, he pointed out that the new infectious diseases, including COVID-19, are caused by the spread of common infectious diseases, and that the 'one-health research system' between the government, industry, and academics should be promptly established. "In recent meetings with pharmaceutical representatives, the development of COVID-19 vaccine is delayed compared to the initial forecast, the more this is done, the sooner the health research system needs to be established." Lee said. Chairman Lee said, “We hope that vaccines and treatments will be made in Korea for the first time in the world, but they have sufficient strategic and industrial value even if they are not the first. It is clear that the message will be supported to the end. The MOHW and the MFDS must fully compensate for the R&D expenses as the President promised." He added, "If the domestic pharmaceutical industry develops a therapeutic drug and makes a profit, it will be reassuring to give it back. We look forward to the day when the Korean pharmaceutical industry will contribute beyond the prevention and diagnosis to the treatment and prevention of humanity."
- Policy
- Dexamethasone would be difficult to use as direct treatment
- by Lee, Jeong-Hwan Jun 19, 2020 06:20am
- While Dexamethasone focused global attention as a candidate for the COVID-19 treatment, the government decided that Dexamethasone would be difficult to use as a direct treatment. The government explained that Dexamethasone, which is considered a relatively old drug, is used to alleviate severe inflammation rather than directly treating COVID-19. On the 17th, at 2 pm, the head of the Central Disease Control Headquarters, Jung Eun-Kyeong, answered the question of using Dexamethasone in a regular briefing question and answer. Dexamethasone is attracting attention as a result of a clinical study published in the UK that significantly lowers the mortality rate of severe patients. However, Jung Eun-Kyeong believes that Dexamethasone would be difficult to use as a fundamental solution to directly treat COVID-19 infection. Head Jung Eun-Kyeong said that Dexamethasone is a steroid-based drug, and although it can be expected to relieve severe inflammation, it is not enough to expect the effect of eliminating the virus itself. In particular, The head hoped that overseas research result for Dexamethasone would not have much effect on the amount of Remdesivir, which is pursuing special import for COVID-19 treatment. She said, "Dexamethasone is a common drug that is used primarily to reduce inflammation. Medical experts have suggested that this drug reduces inflammation, but it also reduces immunity and requires attention. I think it's not a drug that fundamentally treats COVID-19 infection, but an anti-inflammatory drug." She added, "It is necessary to discuss experts such as clinical doctors to determine whether clinical research of Dexamethasone (for direct treatment of COVID-19) is needed. I don't think this medicine will affect other medicines (such as Remdesivir)."
- Policy
- Tagrisso, approved phase III clinical trial
- by Lee, Tak-Sun Jun 18, 2020 06:28am
- Tagrisso, the third-generation medicine for metastatic non-small cell lung cancer with certain types of abnormal EGFR genes is gradually expanding its treatment area. Recently, the results of Phase III clinical trial that proved the effectiveness of Tagrisso as an adjuvant therapy after surgery were released at the American Society of Clinical Oncology (ASCO 2020). The effectiveness of the patient's preoperative adjuvant therapy is also verified at this time. The MFDS approved the clinical trial for 'NeoADAURA' in Tagrisso on the 15th. It is a multinational clinical trial, with 351 patients participating. Of these, 22 are domestic patients. It is also a long-term test scheduled to start in July this year and continue through January 2029. In this study, patients with resectable non-small cell lung cancer, which are positive for epidermal growth factor receptor (EGFR) mutation, are administered as a prior adjuvant therapy alone or in combination with chemical therapy to compare Tagrisso and standard chemotherapy. AstraZeneca has named the test the 'NeoADAURA' test. Earlier, in ASCO 2020 held in May, ADAURA Phase III intermediate results to prove Tagrisso's 'post-surgery adjuvant therapy' were released and made headline. In a study of 682 patients with stage I~III non-small cell lung cancer who had resected the tumor site, Tagrisso was found to reduce the risk of recurrence or death by 83% in patients with stage 2~3A, the primary endpoint. In addition, the risk of death was reduced by 79% in the secondary endpoint including stage Ib patients. If ADAURA is a verification of adjuvant therapy after surgery, NeoADURA, which is being performed at this time, can be said to be a verification of preoperative adjuvant therapy before surgery. A third-generation anti-cancer agent, Tagrisso is indicated ▲ for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test and ▲ for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy . However, insurance benefits have not yet been applied as a primary treatment. Nevertheless,domestic sales amounted to ₩79.2 billion, ranking sixth among all drugs based on IQVIA.
- Policy
- What criteria did it decide whether to introduce Kaletra?
- by Kim, Jung-Ju Jun 18, 2020 06:28am
- What criteria did the government decide whether to introduce Remdesivir and Kaletra, which are used internationally as a treatment for 'COVID-19'? The government explained that the US FDA recently canceled the Hydroxychloroquine's emergency use of 'COVID-19' and that Korea is also considering whether to introduce it in consideration of the global clinical situation. Central Disease Control Headquarters the director of the headquarters deputy director of the Korea Centers for Disease Control and Prevention Jun-Wook Kwon, Vice Head of the Central Disease Control Headquarters, replied to this through a questionnaire at the regular briefing of the Central Disease Control Headquarters today (16th). Currently, the United States has canceled the emergency use of Hydroxychloroquine, and the Korean government has also reviewed this as an important matter and has virtually stopped clinical trials. In our case, the number of patients is rapidly declining, and in the United States, several clinical studies have reported the effects of side effects or insignificant effects, so it is not actually implemented. Vice Head Kwon said, "Currently, our quarantine authorities are applying or recommending that the treatment guidelines recognized or accepted by experts through the Infectious Diseases Association be applied in first-line clinical trials, and the urgent decision of Remdesivir, which was conducted by the US National Institutes of Health, was also made through various reviews by experts such as the Infectious Diseases Association and the Central Clinical Committee." Kaletra is similar to Remdesivir. The reason why experts in the United States are not recommending the use of treatment guidelines is another reason why our authorities are not introducing Kaletra. Vice Head Kwon said, "We will also consider this if the effectiveness of treatment is negative through foreign situations or several papers for effective treatment. However, clinical trials are being conducted in Korea if the test results have not yet been shown."
- Policy
- MFDS, published COVID-19 vaccine clinical trial guidelines
- by Lee, Tak-Sun Jun 18, 2020 06:28am
- The MFDS announced on the 16th that it has published guidelines to help early entry into the clinical trial of COVID-19 vaccine and support its commercialization. The main contents are: ▲requirements for quality data of clinical trial drugs ▲considerations for non-clinical studies such as toxicity tests cConsiderations for the first clinical trial ▲considerations for setting safety, efficacy, and immunogenicity evaluation items ▲The World Health Organization (WHO)’s COVID-19 vaccine Guidelines (Appendix). Development status of COVID-19 vaccines Meanwhile, the MFDS provides customized consultations to 11 companies developing COVID-19 vaccines through the 'Rapid Examination Promotion Group for K-Vaccine' and supports them to quickly enter the clinical trial stage. The Group consists of the 'Exclusive Examination Team' that oversees vaccine screening, the 'Situation Support Team' dedicated to internal and external business cooperation, and 'external expert advisory groups' such as academics and hospitals. Currently, 11 cases including 2 cases of clinical approval and 9 cases of non-clinical development are supported. An official from the MFDS, "We plan to actively support vaccine developers by providing new scientific information and clinical trial information at home and abroad so that the COVID-19 vaccine can be developed in Korea soon."
- Policy
- MFDS talks of choline alfoscerate efficacy reevaluation
- by Lee, Tak-Sun Jun 17, 2020 06:22am
- Director Kim Young-ok of Pharmaceutical Safety Bureau at MFDS Director Kim Young-ok of Pharmaceutical Safety Bureau at Ministry of Food and Drug Safety (MFDS) explained that the efficacy reevaluation on cognitive enhancer choline alfoscerate is in progress according to the principle, and the Central Pharmaceutical Affairs Deliberation Committee would assess the need for the clinical efficacy reevaluation. The director’s statement ultimately refuted the criticism the clinical efficacy reevaluation was announced too late, as the Health Insurance Review and Assessment Service (HIRA) has decided to reevaluate the drug’s reimbursement. On June 16, Director Kim met with correspondents at MFDS headquarters in Osong, and said the announcement of clinical efficacy reevaluation was belated and stressed “Decision-making procedure of the choline alfoscerate efficacy reevaluation is taking proper steps by the book,” while “The Ministry of Health and Welfare’s (MOHW) reimbursement reevaluation scheduled in June also seems to be on its track.” MFDS plans to convene the Central Pharmaceutical Affairs Deliberation Committee on June 19 to discuss conducting a clinical efficacy reevaluation on choline alfoscerate as skepticism on the drug’s cognitive enhancing benefit has been questioned. However, the ministry’s plan was disclosed only after HIRA officially stated Drug Reimbursement Evaluation Committee (DREC) on June 11 has called for the reimbursement standard adjustment on choline alfoscerate. And the public reacted with reproach on MFDS’ belated reevaluation plan. HIRA apparently has decided to raise the copayment rate to 80 percent for prescribing choline alfoscerate in other use besides dementia treatment. The public’s criticism is mainly on the sluggish planning of MFDS as the ministry has already collected all evidences regarding the drug’s efficacy from the manufacturers and suppliers in last November. Commenting on the criticism, Director Kim elaborated, “The initial evidence submitted were limited and the ministry has been reviewing all materials to see additionally required evidences,” also “the ministry consulted with experts and internally reviewed with National Institute of Food and Drug Safety Evaluation (NIFDS) on efficacy and benefits.” The ministry claims it is taking the next step of consulting with Central Pharmaceutical Affairs Deliberation Committee of running a Special Reevaluation (clinical efficacy reevaluation) on choline alfoscerate. Although the procedure was delayed amid COVID-19, the director argues the ministry was not deliberately slowing down the procedure. Director Kim noted, “The Central Committee would decide whether or not to conduct the reevaluation, and if so then the most adequate method of reevaluation would be discussed,” and “the ministry would officially disclose the result of the Central Committee decision and related procedure.” However, the director emphasized MFDS would make the final decision as the Central Committee is actually not a deliberation committee but a consultative committee. On the question raised about the low success rate in clinical trials with dementia patients and adequacy reviewing of them, Director Kim also answered the committee would cover the design of clinical trial, taking account of various circumstances.
- Policy
- DAA Daklinza and Sunvepra to be pulled out from Korea
- by Lee, Tak-Sun Jun 17, 2020 06:21am
- ‘Daklinza plus Sunvepra,’ the first direct acting antivirals (DAA) in Korea praised to have opened the era of ‘curable hepatitis C,’ would be withdrawn from the Korean market after five years since the launch. Bristol Myers Squibb (BMS) Korea, a supplier of the drug in Korea, has recently reported Ministry of Food and Drug Safety (MFDS) that the supply of Daklinza (daclatasvir) and Sunvepra (asunaprevir) would be halted due to the expanded treatment options of hepatitis C decreasing the demand on the drugs. Apparently, BMS Korea has already ceased supplying Sunvepra. The company projects Daklinza would be supplied until around March next year, considering the 243 cartons of stock confirmed as of Jan. 30, 2020. Daklinza plus Sunvepra, or the ‘DakSun combination therapy,’ was approved by the Korean health authority as a first DAA drug in April 2015. Previously, interferon injection or ribavirin were used to treat patients with hepatitis C, but the cure rate was low without directly acting on the virus. Since the release of DAA drug, the hepatitis C treatment has been showing over 90 percent cure rate. Other treatment options with improved administration regimen were released as well. Currently, the combination therapy has been pushed down from the first-line treatment option. Zepatier, Harvoni, Viekira/ Norvir plus Exviera, Daklinza plus Sovaldi and Mavyret are available as the first-line DAA treatment options at the moment. With the change in first-line treatment options, the DakSun combination therapy’s sales in Korea have dropped significantly. As of 2016, UBIST data showed Daklinza generated 36.8 billion won and Sunvepra made 9.3 billion won for outpatient prescription, but their sales plummeted to 300 million won and 100 million won, respectively. With the high cure rate, the overall number of patients fell sharply and halved the DAA market size. The 100 billion-won market in 2016 has shrunk down to 50 billion won last year. Now, the top selling DAA drug in Korea is AbbVie’s Mavyret making 40.3 billion won last year. The drug is leading the Korean market with the advantage of curing the virus within eight weeks. Other DAA options are generating less than 5 billion won a year. The pharmaceutical industry sees that such shift in the market has made withdrawal of Daklinza and Sunvepra in Korea inevitable.
- Policy
- Phase III trial of Eylea biosimilar is ready to kick off
- by Lee, Tak-Sun Jun 16, 2020 06:20am
- Samsung Bioepis is accelerating the development of a macular degeneration treatment, Eylea biosimilar (Aflibercept, Bayer Korea). The development stage is the most advanced in Korea. On the 11th, the MFDS approved phase III global clinical trials for Eylea biosimilar ‘SB15’ by Samsung Bioepis It is phase III trial comparing the effectiveness, safety, pharmacokinetics and immunogenicity between SB15 and Eylea in subjects with neovascular age-related macular degeneration. As a multinational clinical trial, 66 out of 446 subjects participated in Korea. Clinical trials are conducted at Kyunghee University Hospital, KUMC, KU Ansan hospital, Nune Eye Hospital, Pusan National University Hospital, Bundang Seoul National University Hospital, Samsung Medical Center, YUMC, Haeundae Paik Hospital, and AMC. Eylea, along with Lucentis, is the world's most used treatment for macular degeneration. It was released in July of that year with domestic approval in March 2013. As of IQVIA, 2019 domestic sales amounted to ₩46.8 billion. The domestic market outperformed Lucentis (Novartis), which recorded ₩30 billion. Domestic indications include not only for the treatment of neovascular age-related macular degeneration, but also for the treatment of vision damage caused by retinal vein obstructive macular edema/diabetic macular edema and by choroidal neovascularization due to pathological myopia. The domestic related patent (Modified chimeric polypeptide with improved pharmacokinetic properties) is expected to expire on January 9, 2024. There is no commercially available Eylea biosimilar to date. SCD Pharm and Alteogen are developing along with Samsung Bioepis in Korea. SCD Pharm was approved for phase III clinical trial by the US FDA in May. However, domestic clinical trials have not yet been approved. Alteogen was approved for clinical trial I by the MFDS in May last year, and was administered to the first patient in February. Eylea Biosimilar by Alteogen will be manufactured and supplied by DMBio and will be sold in the domestic market by Hanlim Pharm when commercialization and development are completed. Samsung Bioepis is the first phase III trial in Korea. Since 2017, Samsung Bioepis has also been conducting phase III clinical trials of the Lucentis biosimilar, which is the competitive drug of Eylea, and is expected to be approved soon as it is said to have been completed at the end of last year.
