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- 2025-12-25 17:28:52
- Policy
- COVID-19 vaccine likely to be approved w/o clinical trials
- by Lee, Tak-Sun Nov 16, 2020 06:02am
- The COVID-19 vaccine candidate material, which is showing a rapid pace in commercialization, is expected to undergo bridging study after the market because clinical trials are difficult in Korea. The clinical trial is difficult because, ironically, there are few COVID-19 confirmed cases in Korea. On the 10th, Pfizer USA and BioNTech, Germany are developing a vaccine candidate for COVID-19, showing an effect of preventing viral infection in about 90% of subjects as a result of the interim clinical trial. Pfizer is undergoing phase III clinical trials with 43,538 people. This interim result is based on data that about 90% of cases occurred in the placebo group as a result of analyzing 94 confirmed cases of COVID-19 in the group receiving the COVID-19 vaccine and the group receiving the placebo. In other words, only 10% were confirmed in the COVID-19 vaccine group. The Korean quarantine authorities plan to promote domestic introduction by looking at the final clinical results while being cautious about the intermediate clinical results. However, in Korea, clinical trials prior to domestic approval seem to be practically difficult. This is because the efficacy of the vaccine can be confirmed only when the target number of confirmed patients is reached. The clinical trial of Pfizer's vaccine will also continue until 164 confirmed cases of COVID-19 are reached. It is pointed out that in Korea, where there are few confirmed cases, it is virtually difficult to proceed with a clinical trial waiting for a confirmed case to occur in the test group. Accordingly, it is known that there is a high possibility of verifying whether the vaccine is effective in Koreans through a bridging study after marketing after approval of the vaccine based on multinational clinical trials. A bridging study refers to a test conducted for Koreans when it is difficult to apply foreign clinical data due to racial differences. To date, there has been no case of an overseas vaccine for COVID-19 applied for permission to the MFDS. However, the MFDS believes that the COVID-19 vaccine jointly developed by AstraZeneca and Oxford University will apply for approval soon, and is undergoing preliminary evaluation. Preliminary screening is conducted by the MFDS’ exclusive review team 90 days before the expected date of application for products that are expected to apply for permission. The Pfizer vaccine is also expected to undergo preliminary screening and approval early.
- Policy
- The introduction of vaccine will be discussed after results
- by Lee, Tak-Sun Nov 12, 2020 06:28am
- The MFDS said it would discuss the final clinical results of Pfizer's COVID-19 vaccine, which showed the potential for clinical success, for introduction. Seo Kyung-won, the head of the drug review department at the MFDS, made such a statement at a briefing on the approval status of vaccines for the treatment of COVID-19 held on the 10th. She said, “According to Pfizer's announcement, the interim results of a phase III vaccine trial resulted in 94 infected patients with 38,599 vaccines twice on the 8th.” She also reported that the vaccinated group had more than 90% of the preventive effect when compared to the non-vaccinated group. "Intermediate results seem positive, and phase III trials are currently in progress in six countries including the US and Brazil," she added. The phase III clinical trial ends when 164 confirmed cases are found. She said, “We will comprehensively judge the final clinical results and determine whether it is effective or not, such as safety, duration of immunity, and effects on the elderly.” “We have been continuously monitoring the test results, but we will continue to closely monitor the test results, and we plan to discuss the introduction at the government level.”
- Policy
- Boryung introduced Symbenda's first generic in Korea
- by Lee, Tak-Sun Nov 12, 2020 06:19am
- #Boryung introduces a generic drug which was reimbursed in 2 years ago. Boryung's Bendamustine HCl is the first generic for Symbenda. The MFDS approved Boryung's Bendamustine HCl on the 11th. It is a generic for Symbenda which was approved by Ezai Korea in 2011, and is the first generic in Korea. Symbenda was approved in 2011, but it took seven years to be reimbursed. It has been listed in September 2018. BR (Bendamustine/Mabthera (Rituximab)) therapy was successfully applied in Follicular Lymphoma (FL) with no previous treatment experience, raising expectations. BR therapy is recommended as a first-line treatment for follicular lymphoma patients in the United States and Europe. Follicular Lymphoma accounts for about 3% of all non-Hodgkin lymphomas, an average of 150 patients a year, and most of them are 55-60 years old. BR therapy demonstrated the efficacy of improving overall health status and improving quality of life in terms of cognitive, emotional, and social function in a phase III study compared with standard therapy R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin HCl, Vincristine Sulfate, and Prednisolone). .The safety aspect is improved compared to the existing Mabthera-based chemotherapy combination therapy .Last year, Symbenda recorded sales of ₩2.5 billion (IQVIA) in Korea .Symbenda's re-examination (PMS) expired on June 16th .As there are no patents listed on the MFDS’ Green List, there are no restrictions for generics to enter .Boryung, which has established a strong sales network among domestic companies in the anticancer drug market, preoccupied the first generics .Boryung is also developing 'BR2002', a new drug for treating non-Hodgkin's lymphoma .BR2002 was approved for phase I clinical trial by the US FDA last year .It has 4 licensed lymphoma treatment systems .Boryung's 'Bendamustine HCl', which was approved this time, is an imported finished drug by Boryung .
- Policy
- Budget Subcommittee passes KRW 965 bln for COVID-19 vaccine
- by Lee, Jeong-Hwan Nov 12, 2020 06:19am
- The Budget and Accounting Evaluation Subcommittee of the National Assembly Health and Welfare Committee has deliberated and decided on the 2021 budget plans for the Ministry of Health and Welfare (MOHW), the Ministry of Food and Drug Safety (MFDS) and the Korea Disease Control and Prevention Agency (KDCA). The subcommittee explained the infectious disease control and healthcare budget has been vastly expanded around 965 billion won for seeking COVID-19 vaccine, whereas unnecessary budget was cut boldly. Apparently, the infectious disease control and prevention budget of 965 billion won was newly allocated to get an access to COVID-19 vaccine. Moreover, 9.52 billion won was allocated to establish regional infectious disease specializing hospitals, and 88.14 billion won was increased for the budget to cover the influenza vaccine cost for the National Immunization Program (NIP) and to expand free immunization program for population aged 14 to 18 and 62 to 64. As for the healthcare sector, improving publicness of regional center hospital added the budget of 110.3 billion won. The subcommittee also put 18.8 billion won on top of the budget for mental health management and suicide prevention due to COVID-19 related depression and for creating a culture of respective human lives. Also the committee increased the government financial aid funding up to 209.2 billion won to lessen the National Health Insurance (NHI) premium in vulnerable community directly impacted by COVID-19. As for food and drug safety management, the budget of 1.77 billion won was additionally reflected to eradicate illegal online distribution of food and drugs, while 6.43 billion won was reflected to expand and enhance Children’s Meal Service Management Center to support small-scale kitchen for children’s meal service. The clinical trial safety standard reinforcing project and clinical trial management system to promote development of new drug including COVID-19 treatment received the budget of 5.32 billion won. Meanwhile, the Budget Evaluation Subcommittee significantly revised the KDCA budget, as an independent agency budget, because it was initially submitted to the National Assembly as a part of MOHW. The original budget plan under the MOHW approval allocated 36.10 billion won in 33 tax revenue programs and 341.86 billion won in 65 tax expenditure programs. But the plan was revisited and amended for the independent government institute of KDCA. Basically, the subcommittee provided a solid financial foundation for KDCA to execute infectious disease control and prevention as a standalone central administration agency. The Health and Welfare Committee is to convene a general meeting and to deliberate the budget plans passed by the subcommittee at 5 PM on the same day. The Budget and Accounting Evaluation Special Committee would then comprehensively assess the budget plans. The budget review procedure would be completed after the National Assembly plenary session passes the finalized plan.
- Policy
- Pfizer’s COVID-19 vaccine needs to be reviewed
- by Kim, Jung-Ju Nov 12, 2020 06:19am
- With the interim results announced that the effectiveness of the COVID-19 vaccine being developed together by Pfizer in the United States and BioNTech in Germany is more than 90% effective, the Korean government has decided to take a cautious approach in the future. It is because the clinical results of other products are expected to be released sooner or later, and safety is the top priority, so there is no need to worry about supply and demand. Joon-Wook Kwon, the second vice president of the Central Disease Control Headquarters (Director of the Korea National Institute of Health), answered the news of Phase III clinical trials of Pfizer's vaccine and the direction of response to supply and demand of vaccines in Korea through a briefing during the day on the 10th. Currently, Korea is in the process of securing the COVID-19 vaccine through bilateral consultations with some global pharmaceutical companies following the COVAX organization. However, the progress of pre-purchase is not disclosed through agreements with companies, but pre-purchase of products that have entered phase III clinical trials worldwide are being discussed. In other words, this drug also belongs to the group of drug candidates that Korea can select through international organizations that have already paid the advance payment. Pfizer's Phase III clinical trial is the fastest news among them. Pfizer analyzed 94 people infected with COVID-19 among the participants of Phase III on the 9th of the local time, and found that the drug being developed is showing a 90% preventive effect. However, in the case of Pfizer, the UK has already announced the pre-purchase, and Germany has also declared priority to supply its own people. Accordingly, the domestic supply and demand situation is also a concern. He said, "It is obvious that (Pfizer's phase III clinical trial) is in a good situation, so that it is difficult to find a case that achieved good results through clinical phase III in 9 months." also he added that we are looking at additional results and comprehensively reviewing various drugs being developed by other companies besides Pfizer. He said, “Based on our experience now, there are no cases of good results through phase III clinical trials in 9 months,” he said. “ However, as a quarantine authority, Pfizer confirmed additional results and Besides, we are looking at various drugs being developed by other companies.” However, we reaffirmed our cautious position on concern that the opportunity for Korea to pre-purchase will be diminished due to the supply of domestic companies by developers. He said, "It's not that we're going to do the pre-purchase slowly. The pre-purchase will do our best to proceed normally, but the actual vaccination results of other countries, and adverse reactions or problems occurring in the field, etc. "I will check closely and do it slowly." He also emphasized that "the vaccine will be carefully judged by watching the vaccination situation in other countries."
- Policy
- The re-evaluation of α-GPC will be implemented next month
- by Lee, Tak-Sun Nov 11, 2020 08:48am
- The MFDS stated that the clinical re-evaluation schedule of the brain function improving drug, Choline alfoscerate has not changed. The clinical plan must be submitted by the 23rd of next month. If the deadline is not met, the sale will be suspended immediately. Shin Seung-seung, an official of the Drug Safety Assessment Division of the MFDS, met with a reporter on the 10th and said this. She explained, "The companies must submit a reasonable plan to recruit enough subjects, it is about 90 days until the plan is reviewed, and it may be extended if supplementation comes out." In principle, the MFDS is in the position that all indications for Choline alfoscerate should undergo clinical reevaluation. However, if there is a basis in the plan submitted by the company, it will be carefully reviewed through expert advice. The industry argues that Choline alfoscerate should be excluded from clinical re-evaluation as it has been recognized for its clinical usefulness when re-evaluating the benefits of the HIRA in relation to the efficacy of dementia. Regarding this, she said, "there has not yet been received by companies or expert groups regarding clinical reevaluation." In addition, she said, "In order to maintain the indication, it is a principle to undergo clinical trials for the three approved effects, but a plan must be submitted first." Currently, the issue of reimbursement recovery on the premise of a clinical reevaluation failure is also being discussed. In this audit of the state administration, Nam In-soon, a member of Democratic Party of Korea, mentioned the necessity of a plan for insurance finances, and the MOHW also said, "We will review various measures including contracts between the NHIS and pharmaceutical companies. Accordingly, if the clinical reevaluation fails, the possibility of benefit redemption and negotiations with the related government and pharmaceutical companies increased. However, regardless of this, the MFDS plans to proceed with clinical re-evaluation without any change in schedule. She said, "We will share the data with the MOHW, but the clinical re-evaluation will proceed separately from the drug price issue, and the schedule will not be delayed." The deadline for submitting the clinical re-evaluation plan for Choline alfoscerate preparations is until December 23, and if this is the first violation, the product will be suspended for two months, the second will be suspended for 6 months, and the third will be canceled.
- Policy
- Yuhan’s no-food-required fenofibrate tablet approved
- by Lee, Tak-Sun Nov 11, 2020 06:07am
- Yuhan Corporation Yuhan Corporation has received the health authority’s approval on a fenofibrate tablet, orally taken regardless of meal consumption, to treat hyperlipidemia. The form and administration method are unique to the drug only in South Korea. GC Pharma with the original fenofibrate Lipidil supra is also in process of developing a tablet with the same dosage form. On Nov. 5, the Ministry of Food and Drug Safety (MFDS) granted an approval on Yuhan’s ‘Yuhan Fenofibrate 145 mg Tablet.’ Used to treat patients with primary hyperlipidemia, the newly approved drug in a 145-mg tablet is taken orally for once daily with or without having a meal. The existing fenofibrate tablets were in 160 mg dose and taken after a meal to facilitate the drug absorption. Yuhan conducted a bioequivalence test on its tablet drug and confirmed the equivalence with Abbott’s Tricor that has not been released in South Korea. Tricor is a new form of fenofibrate, approved by the U.S. Food and Drug Administration (FDA) in 2004. Unlike other fenofibrate forms, the absorption in gastrointestinal tract is faster and it can be consumed without food consumption. The unique form has not been introduced to the Korean market, yet. GC Pharma initially got ‘Lipidil NT’ approved for the market with the same substances and form, but the company dropped the license voluntarily in 2014. GC Pharma is currently working on developing the form. In last August, the company had a Phase 1 trial approved to compare its 145-mg fenofibrate tablet against Tricor as a reference drug. But Yuhan nabbed the item approval first and claimed the chance to open the market before GC Pharma. Besides fenofibrate, similar drugs like fenofibric acid and choline fenofibrate have a variety of products that can be taken without a prior food consumption. Hanmi Pharmaceutical’s Fenocid Capsule (fenofibric acid), Daewon Pharmaceutical’s TG Fenon Tablet (choline fenofibrate) and Korea Pharma’s Fenocholine Capsult (choline fenofibrate) are the examples. Abbott has also launched a combination drug Cholib Tablet (fenofibrate plus simvastatin). Although Abbott’s single agent drug Trilipix Capsule (choline fenofibrate) was approved for the market in 2013, the license was dropped when it was expired in January 2018. Recently, fenofibrate drugs have been used frequently to treat patients with hypertriglyceridemia. As one of hyperlipidemia, hypertriglyceridemia has a high prevalence rate and requires drug treatment to lower the cardiovascular event risk as it cannot be managed only through strict diet and exercise. Statin drugs are used the most on hyperlipidemia, but it demonstrate low response rate in drug administration. To cover the flaw, fenofibrate drugs are also prescribed usually in combination.
- Policy
- A tough market for new Rosuzet generic
- by Lee, Tak-Sun Nov 10, 2020 06:06am
- Hanmi Pharmaceutical’s rosuvastatin-ezetimibe combination drug Rosuzet Although the door for generics is to open next year when the post marketing surveillance (PMS) period is terminated for the rosuvastatin and ezetimibe combination drug treating dyslipidemia, the market annually generating 150 billion won is actually not expecting any new generic. Many of pharmaceutical companies have already received the South Korean health authority by manufacturing drugs on consignments with substituting evidence submission. Only the companies turn the consigned manufacturing to direct manufacturing are conducting bioequivalence test with the reference drug Rosuzet by Hanmi Pharmaceutical after the PMS termination. The Ministry of Food and Drug Safety (MFDS) reported on Nov. 9 that the ministry has granted approval for bioequivalence test on only four pharmaceutical companies to confirm body absorption of their drugs compared against Rosuzet. The approved companies are Aprogen Pharmaceuticals, HK inno.N, Korea Prime Pharm and Jeil Pharmaceutical. Aprogen Pharmaceuticals and Korea Prime Pharm did not have approved item by the point of bioequivalence test approval. But the two companies had their products approved recently through their consigned manufacturer by sharing the test result instead of running a direct test. Jeil Pharmaceutical and HK inno.N had already-approved items to receive the bioequivalence test approval. The already-approved products are manufactured on consignments. The bioequivalence test would be conducted to switch to direct manufacturing. Compared to the consigned manufacturing, directly manufacturing the products could raise the profit ratio. It also has an advantage of maintaining the drug pricing by meeting the condition of bioequivalence test result for the pricing reevaluation. HK inno.N is planning to improve the profit ratio of its Rovazet ranked at the third place in the market by conducting a bioequivalence test. Although there are only seven companies in South Korea manufacturing a rosuvastatin plus ezetimibe combination drug, there are 150 approved items by 50 companies. The seven companies include Hanmi Pharmaceutical with the first-listed Rosuzet, Yuhan with Rosuvamibe ranked at the second place, and other companies like Daewon Pharmaceutical, Shin Poong Pharm, Aju Pharm, Alvogen Korea, and Ildong Pharmaceutical. Among those companies, Daewon Pharmaceutical and Shin Poong Pharm are entrusted with manufacturing of the drug by four companies, Aju Pharm by 14 companies and Alvogen Korea by 20 companies. These drugs are technically not a generic. But they are incrementally modified drugs approved with evidence submission. The consigned items have also submitted the identical evidence for approval based on the shared material. Accordingly, the same PMS terms would be applied until June 7. Regardless of the market generating 150 billion won annually, a new generic drug is unlikely to be developed as companies that initially prepared for bioequivalence test rather shared the substituting evidence with other companies and received item approval. The already-listed drug’s pricing is set with a sum of 53.55 percent of each individual drug. So a new generic would not get reduced pricing. However, based on the stepped pricing system, a new generic could receive the lowest pricing when listed later. With 20 same substance drugs already listed since last June, a new applicant drug would be automatically priced at 85 percent of the lower price between the lowest price or 38.69 percent of the upper limit price. Hence, the worst environment for a new generic has been created. The pharmaceutical industry insider commented, “As for the rosuvastatin and ezetimibe combination drug market, too many companies have resorted to sharing the submitted evidence to avoid the stepped pricing. Most of the companies could actually enter the market before the PMS period ends.”
- Policy
- NA “Age over 65 pneumococcal vaccine should use Prevenar13"
- by Lee, Jeong-Hwan Nov 10, 2020 06:05am
- The National Assembly pointed out the National Immunization Program (NIP) for the pneumococcal vaccine for elderly population aged over 65 should be switched from the existing 23-valent pneumococcal protein polysaccharide vaccine (PPSV23) to 13-valent pneumococcal conjugate vaccine (PCV13). The lawmakers claim the state should provide expensive PCV13, instead of comparatively more inexpensive and less preventive PPSV23, to have proper preventive effect against pneumonia in high-risk population amid COVID-19 pandemic. As Prevenar 13 is the only approved PCV13 in South Korea, the National Assembly recommended the NIP to replace Pneumo 23 and Prodiax-23, currently provided for free of charge at public healthcare center, with Prevenar 13. On Nov. 4, the Senior Expert Committee Office of the National Assembly Budget and Accounting Evaluation Special Committee addressed the recommendation when reporting the review result of 2021 budget plan by Korea Disease Control and Prevention Agency (KDCA). The KDCA’s NIP budget plan for 2021 allocated 347.79 billion won with 9.04 billion won (2.7 percent) increased from this year. The NIP offers PPSV23 once as a pneumococcal vaccine for the elderly population aged over 65 at a public healthcare center. Due to COVID-19 hindering the immunization at the healthcare centers, the vaccine is provided temporarily from last June 22 to Dec. 31 this year at designated healthcare institute. The Expert Committee Office of the Budget and Accounting Evaluation Special Committee ordered KDCA to consider using PCV13 for the pneumococcal vaccination program to improve prophylaxis against pneumonia amid COVID-19 pandemic. At the moment, Pfizer Pharmaceutical Korea’s Prevenar 13 is the only PCV13 approved for the South Korean market. SK Bioscience was the first Korean company to develop and receive the health authority approval on a PCV13 Skypneumo, but the company lost a patent challenge against Prevenar 13 and had to voluntarily drop the license in South Korea as it failed to evade the patent. The committees explained the recommendation was made, because the number of deaths by pneumonia in elderly population aged over 65 has been increasing steadily in last five years and preventing pneumonia in high-risk group became crucial due to COVID-19. In fact, the number of deaths by pneumonia in population aged over 65 has been surging from 13,701, 15,263, 18,202, 21,820 to 21,855 in year 2015 through last year, respectively. The Expert Committee Office said, “The high-risk group with senior citizens and people with underlying disease forms less antibody with PPSV23 and their duration of sustained antibody is also short. So the vaccine’s preventive effect against pneumonia has been controversial. The 2018 guideline for adult immunization recommends combination of PCV13 and PCV13 in immunosuppressed, asplenic, cerebrospinal fluid leaking and cochlear implanted adults over age of 65 years, who have not been immunized with the vaccine before.” The office added, “While the COVID-19 pandemic has not been fully contained, the government should review providing PCV13 for the high-risk population of age over 65 years as a part of NIP to see effective prophylaxis against pneumonia.”
- Policy
- Kang-rip Kim emphasized COVID-19 tx & vaccine development
- by Lee, Tak-Sun Nov 10, 2020 06:05am
- Kim Kang-rip, head of the MFDS, is greeting Kang-rip Kim (54 yrs old), the new head of the MFDS, emphasized, "We must concentrate our regulatory competencies as much as possible for the development of COVID-19 treatment and vaccine." At the inauguration ceremony held at the headquarters of the MFDS in Osong, Chungbuk on the evening of the 2nd, he said that he is at the forefront of critical work to overcome the era of COVID-19. He said, "First of all, we must mobilize our regulatory capabilities to develop COVID-19 treatments and vaccines that are safe for the public. We will develop new technologies and create a regulatory environment that can effectively respond to future medical demand through rational regulation. It is also important.” At the same time, he proposed four goals that centered on the life and safety of the people. The first goal is professional safety management. He said, "The MFDS will respect expertise as a top priority, and we will cultivate professional manpower, improve the workforce management system, and improve the working environment so that we can grow this area." The second is the strengthening of international competitiveness, he said that he will create a policy environment with comparative advantage by referring to countries with advanced regulations, and that he will foster a harmonious international model that promotes the technology industry based on safety and quality management. It will strengthen cooperation in international cooperation. Director Kang-rip Kim (right) is greeting the staff Third, he emphasized open organization and collaboration. It is to create a work environment based on internal and external communication, strive to communicate with major policy customers and other ministries, and work together to achieve results. Lastly, he emphasized that he will prepare international food regulations and respond proactively to innovative medical care in the future, saying that he will pursue future values based on strong safety. He said, "The MFDS is at the forefront of important tasks that determine the future of Korea in the context of COVID-19. I have a duty to present a path to save health, safety and economy together, not only to respond to COVID-19, but also to biohealth growth." He said, "I always believe in our ability to overcome the COVID-19 era and look forward to our ability." As a member of the MFDS, he pledged to work together with fierce thoughts. Lastly, he said, "I spent exactly 30 years and a few days in the Welfare Department, responsible for the happiness of the people, and worked in a culture that cares for people. I hope that leadership that can maximize the total happiness of each and every organization is established as a desirable leadership." The inauguration ceremony was held in the meeting room space in consideration of a non-face-to-face distance, similar to the retirement ceremony of Director Lee Eui-kyung in the morning, and only senior officials attended. He graduated from Yonsei University and was appointed as the 6th head of the MFDS on the 1st. At the MOHW, he worked as the head of the Insurance and Reimbursement Division, the Head of the Policy Team for the Disabled, the Head of the Medical Policy Team, the Head of the Health and Medical Policy Division, the Head of the Health Industry Policy Bureau, the Social Service Policy Officer, the Pension Policy Officer, and vice minister.
