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- 2026-04-15 16:52:52
- Policy
- Will the Committee allow AZ vaccine in the elderly?
- by Lee, Tak-Sun Feb 08, 2021 06:08am
- This is because the Central Pharmaceutical Affairs Review Committee, a specialized advisory body for the MFDS, determines the adequacy of the approval from 2pm. While it is expected that the Central Pharmaceutical Affairs Review Committee has decided on item approval, it is noteworthy how it will decide on the administration of the elderly. Earlier, the 1st expert meeting, Verification Advisory Group, suggested the use of the vaccine, saying, "There is no reason to exclude the administration of AstraZeneca’s vaccine to the elderly." The MFDS will hold an advisory meeting on the Central Pharmaceutical Affairs Review Committee for AZ Vaccine in a conference room at the headquarters in Osong, Chungbuk at 2 pm on the 4th. The MFDS is holding expert meetings three times in the case of COVID-19 vaccines and treatments. Final approval is decided through the first verification advisory group, the second Central Pharmaceutical Affairs Review Committee, and the third final review committee. In general, the agenda has been decided mostly through the Central Pharmaceutical Affairs Review Committee. In consideration of public interest and securing trust in screening for COVID-19 vaccines and treatments, the expert meeting was increased three times. However, since the committee has made a final decision, it seems that the approval of AZ vaccine will be decided through this meeting. The number of participants in AZ's COVID-19 vaccine clinical trial (UK and Brazil) was 8,895 adults over the age of 18 (4,440 vaccine groups, 4,455 control subjects). The average age was 42.2 years old, and 7.4% (660 people) of the elderly over 65 years old verified the effectiveness. Some European countries have recommended vaccination restrictions due to the fact that there are fewer seniors in clinical trials. Authorities in Germany, France, Sweden, Austria, Poland, Italy and Belgium recommended that older people should limit vaccination. However, the European Medicines Agency (EMA), which oversees drug approval in EU countries, did not place any restrictions on the administration of AZ vaccine to the elderly. The verification advisory group, who first consulted on whether or not to obtain permission in Korea, also stated that there was no reason to exclude the administration of the elderly. At the verification advisory meeting held on January 31 of last month (including 8 infectious internal medicine specialists, clinical statistics specialists, etc.), a number of experts said, "It is impossible to rule out administration to the elderly just because the number of elderly persons among the participants is small." However, some opinions suggested that the administration of the elderly aged 65 or older should be decided through additional clinical trials. A number of experts from the advisory group said, "In the clinical trial of the AstraZeneca’s vaccine, the prevention effect was confirmed in all subjects, including over 65 years of age, and the immune response after white administration is similar to that of adults and the safety profile is good." A small number of experts say that the preventive effect has not been proven due to lack of data, and that the antibody titer is lower than that of adults under the age of 65 and that the correlation between the immunogenic response and the preventive effect has not been established. In the end, according to the majority opinion, the verification advisory group recommended that vaccination is possible even for elderly people over 65 years of age. The meeting is expected to involve more experts than the verification advisory group. Earlier, a total of 18 people, including members of the verification advisory group, attended the Central Pharmaceutical Affairs Review Committee of Celltrion's COVID-19 treatment Rekirona. The results of the Central Pharmaceutical Affairs Review Committee meeting in Rekirona were different from that of the Verification Advisory Board. While the verification advisory group determined that it could be used for all mild patients, the Central Pharmaceutical Affairs Review Committee recommended that only high-risk patients be allowed among mild patients. Therefore, even at the Central Pharmaceutical Affairs Review Committee meeting of AZ’s vaccine, the possibility of results contrary to the previous verification advisory's position to allow the administration of the elderly cannot be excluded. It is analyzed that there is a high probability that a similar decision will be made in Korea as the European EMA, the agency most trusted by the MFDS, has not placed restrictions on vaccination for the elderly. If AZ vaccine is limited to the administration of elderly people, the vaccination plan should be changed. This is because most of the vaccines vaccinated in the first quarter are AZ vaccine. In particular, elderly people in nursing hospitals have difficulty in getting the Pfizer vaccine, which is introduced in mid-February because of their mobility. Pfizer vaccines require frozen storage and can only be inoculated at specific centers.
- Company
- Sanofi disturbs distributors with first vaccine bidding
- by Feb 08, 2021 06:08am
- Sanofi Pasteur, a first pharmaceutical manufacturer to jump into the vaccine bidding market and stir up the pharmaceutical distributor industry, could not ink the final procurement agreement. The company dropped its agreement offer as it failed to meet the bidder qualification standards. A pharmaceutical distributor industry reported on Feb. 4, although Sanofi Pasteur won the military camp hepatitis A virus vaccine procurement bidding via the Korea Online E-procurement System late last month, the company did not pass the bidder review. Valued at 6.3 billion won, the bidding was intensely competitive with total 47 companies participating. And Sanofi Pasteur was the only pharmaceutical manufacturer among pharmaceutical distributor bidders. Sanofi Pasteur apparently offered the lowest price among all bidders (80.576 percent of the previously procured price), and was selected as a top choice. And the pharmaceutical distribution industry was thrown into turmoil as the multinational pharmaceutical manufacturer won the initial bidding. So far, by tacit agreement, the vaccine bidding market was exclusively owned by distributors. But Sanofi Pasteur broke the unspoken rule and entered the bidding. And because of the surprise participation, the general bidding price dropped. Sanofi Pasteur also joined the meningococcal vaccine bidding opened around the same time. The company did not win the bidding, but the distributor industry definitely noticed the shocking action. Regarding the distributor industry’s fierce disapproval, Sanofi Pasteur firmly responded the direct bidding participation is not problematic, but the company had an unforeseen issue. The Public Procurement Service selected the multinational company as a top choice, but the manufacturer failed to meet certain conditions. The government agency official said, “Sanofi Pasteur voluntarily withdrew from the bidding due to unqualified review score. The agency is currently reviewing the second choice of the bidder.” It indicated the end of Sanofi Pasteur’s attempt in the bidding, but the industry is still tensed up from the happening, because a pharmaceutical manufacturer directly bidding for a government procurement deal could threaten the existence of the distributor industry. The manufacturer also mentioned of possibly participating in other biddings in the future. On Feb. 3, the Vaccine Business Committee associated under Korea Pharmaceutical Distribution Association was convened to talk about response strategy against similar prospective issues. The committee stressed mutual understanding and consideration from the vaccine manufacturer and importer are needed, and agreed that the government and each pharmaceutical company should clarify their scope of bidding. Particularly, the current bidding system only stipulates the basic qualification for the bidders to be a pharmaceutical wholesale distributor. The committee members raised their voices that the regulation should be amended to consider a bidder’s refrigerated transportation and vaccine distributing capacity to properly select the winning bidder. A pharmaceutical distributor industry insider said, “At the moment, the number of vaccine distributors is limited. But if manufacturers start taking over the bidding, then vaccine distributors would be unable to survive the market. Pharmaceutical manufacturers and distributors should form to a mutual relationship.” The association plans to disseminate official statement to each manufactures to request for cooperation, and to file a formal complaint to the authority to revise the relevant regulation.
- Policy
- Government-pharmaceutical organizations discuss measures
- by Lee, Jeong-Hwan Feb 08, 2021 06:07am
- The MOHW and medical groups discussed COVID-19 vaccination plan and comprehensive measures to strengthen health insurance non-reimbursement management. The operation plan of the Health and Medical Personnel Policy Deliberation Committee was also on the agenda of the meeting. On the 3rd, the MOHW (Minister Kwon Deok-cheol) held the 4th working-level meeting with pharmaceutical organizations at the Korea Health Promotion Institute. It was attended by Health and Medical Policy Officer Lee Chang-joon of the Ministry of Welfare, Health and Medical Policy Manager Kim Kook-il, Medical Personnel Policy Manager Kim Hyun-sook, Medical Security Management Manager Gong In Sik, and Health Care Innovation Team Leader Jeong-min Yoo. The KHA Vice Chairman Song Jae-chan, the KDA Vice Chairman Hong Soo-Yeon, the AKOM Vice Chairman Lee Jin-ho, the Korean Pharmaceutical Association Vice Chairman Kim Dong-geun , and the Korean Nurses Association Vice Chairman Kwak Wol-hee were seated. The agenda of the meeting includes comprehensive measures to strengthen health insurance non-reimbursement management, organization and operation plan of health care personnel policy deliberation committee, operation plan of health care personnel support agency, progress of mid- to long-term health care personnel supply and demand estimate, and COVID-19 vaccination implementation plan (draft). Lee Chang-joon said, "We will provide necessary information to patients for effective non-reimbursement management, while discussing ways to minimize the burden on medical institutions and medical personnel, and continue to collect opinions from the medical community and related organizations." said. He explained, "The Health and Medical Personnel Policy Deliberation Committee was organized to reflect the opinions of various roles and classes." This policy officer said, “We will closely discuss the training and supply and demand management of health care personnel, measures to improve the treatment environment, etc. with related ministries, related organizations, and experts. To secure medical personnel necessary for COVID-19 vaccination, education, and designation of a consigned medical institution, etc., Active cooperation with organizations is necessary. The Health and Medical Development Council will actively discuss tasks that are difficult to resolve due to conflicts of interest between the direct sectors and produce results of the operation of the consultative body."
- Company
- What is the expert evaluation of the single dose COVID-19 va
- by Whang, byung-woo Feb 08, 2021 06:07am
- Johnson & Johnson's COVID-19 vaccine, which has the advantage of a single vaccination, has been evaluated as not as expected, revealing 66% of the preventive effect. Experts are suggesting that approval is expected as long as they exceed the minimum standards of the WHO, but the evidence should be supplemented. On the 29th, Johnson & Johnson released the results of clinical trials for its vaccine (Janssen vaccine) at local time. Clinical results show that this vaccine has an average of 66% prophylactic effect (72% in the US, 66% in Latin America, and 57% in South Africa). These results are relatively low compared to Pfizer 95%, Moderna 94.1%, and Novavax 89.3%, which is not good even considering the strength of single dose. This is same as when there was an announcement that AstraZeneca's COVID-19 vaccine had a prophylactic effect of about 62%. However, experts explain that the Janssen vaccine can be approved based on the efficacy criteria of the vaccine published by the WHO. Choi Won-seok, a professor of infectious medicine at Korea University Anam Hospital, said, "When COVID-19 vaccine was first developed, the criterion that we thought we could respond to the epidemic was about 50% of the prevention effect. All the vaccines available so far, including Janssen, have exceeded this standard." He said, "The standard for responding to COVID-19 epidemic is 70%. Janssen recorded an average of 66%, but in the US clinical trials, the result was more than 70%, so it will meet the US Food and Drug Administration (FDA) standards." Johnson & Johnson plans to apply for Emergency Use Authorization from the Food and Drug Administration (FDA) as early as this week, and a preliminary review has been requested in Korea. In this regard, Kang Jin-han, director of the Vaccine Bio Research Institute at Catholic University of Medicine, said, "It is said that if the vaccine prevention effect is more than 50%, it is normal and it is good if it is more than 70%. if the prevention effect is more than 50%, it will be approved." However, he said that while evaluating that a single dose of Janssen vaccine is meaningful, it is also clear that the preventive effect is lower than expected. He said, "The data aren't all public and can't be concluded. The evidence is not clear on how long a single dose lasts independent of the seroconversion rate. It should be said that the preventive effect should be sustained like the two doses, but it is unfortunate that this part is not clear." The Janssen vaccine is a single vaccination and is easy to distribute and store. Who is vaccinated? In addition to the single vaccination, the Janssen vaccine has the advantage of being easy to set up an inoculation plan because it remains effective for more than 3 months in refrigerated distribution and storage, and is delivered in a 5-dose vial package that does not require dilution. The vaccine for 6 million people will be supplied from the second quarter, and Johnson & Johnson is confident that there will be no disruption in the contracted supply. Experts believe that it is effective to first inoculate the elderly living in the facility. Professor Wonseok Choi said, "It is difficult to judge a specific profile before knowing it, so we should prioritize storage and accessibility. However, if there is a limited supply and there is no option of a vaccine, we have no choice but to inoculate at the currently selected priority." He stressed, "If the characteristics of each vaccine are similar and do not have a significant effect, we will have to prioritize vaccination, which shows clinically more effective."
- Company
- Elyson challenges patent of Entresto
- by Kim, Jin-Gu Feb 05, 2021 10:09am
- Novartis' heart failure treatment Entresto (Sacubitril / Valsartan) is expected to be challenged by domestic companies. Interest is focused on whether domestic companies can overcome Entresto's patents, in which a total of 4 patents are registered. According to the pharmaceutical industry on the 4th, Elyson recently filed a judgment against Novartis to confirm the scope of passive rights against Entresto's crystalline patent. In addition to this patent, which expires on September 21, 2027, a total of four patents for Entresto are registered. Product patent expired in July 2027, and two patents for composition expired in November 2028 and January 2029. It is explained that the remaining three patents must be overcome in order to early release generic for Entresto. If all four patents are successfully overcome, Elyson will be able to release the generic after April 13, 2022, when Entresto's PMS expires. Entresto is a heart failure treatment that Novartis launched in Korea in October 2017. In fact, after recording an outpatient prescription amount of ₩6.3 billion in 2018, the first year of its release, it has grown more than three times in two years to ₩20.3 billion last year. For this reason, many domestic companies have shown interest in launching generic for Entresto. It is reported that some companies have also initiated biological equivalence tests. However, there was no company that started a patent challenge. Elyson is expected to challenge the patent of Entresto, which will add challenges from other companies. A pharmaceutical industry official said, "Since last year, not a few pharmaceutical companies have shown interest in patent challenge for Entresto. With Elyson's first patent challenge, there is a possibility that other pharmaceutical companies will continue the patent challenge in about two weeks to meet the initial request for trial."
- Policy
- Phase III fast track for Leclaza·Lynparza was approved
- by Lee, Jeong-Hwan Feb 05, 2021 05:54am
- While a bill was proposed to upgrade the fast track system in phase III to the pharmaceutical affairs law from the public announcement, 62 new drugs were counted to have taken the fast track so far. Most of domestic and overseas anticancer drugs such as Leclaza (Lasertinib) developed by Yuhan, AstraZeneca's Lynparza, Tagrisso (Osimertinib), and Pfizer's Ibrance (Palbociclib), are fast tracked. Biosolution's CartiLife and Tego Science’s Rosmir were also included. On the 4th, the drugs approved by the MFDS for Phase III clinical trial, including drugs related to rare diseases and intractable diseases, as well as anticancer drugs and cell therapy drugs, received special cases of fast track. The CMA system is currently being operated by the MFDS with notice and internal guidelines (guidelines). In particular, the MFDS recently announced a revision of the licensing and management guidelines to improve the predictability of the CMA system in phase III clinical trial. It specifies the target of the fast track in detail, includes the evidence when setting the deadline for submission of the clinical plan, and describes whether or not the Central Pharmaceutical Affairs Review Committee needs consultation. When item approval, the conditions of permission were to be described in the permission details. In addition, the National Assembly is also pursuing a legislation (People Power Party, Jongheon Paik) to upgrade the CMA system of the MFDS to the pharmaceutical affairs law. Among 62 new drugs that followed the CMA track, Leclaza is the 31st domestic drug. Non-small cell lung cancer Leclaza 80mg is the 62nd CMA drug. Leclaza has been transferred to Janssen, a global pharmaceutical company, and is undergoing licensing procedures in other countries such as the United States. AstraZeneca’s ovarian cancer drug Lynparza, Novartis’ metastatic breast cancer drug Kisqali, and Biosolution’s osteoarthritis drug CartiLife were also approved for CMA. Lynparza, Kisqali and CartiLife, excluding Leclaza, were approved on January 18 this year, were CMA in 2019. Takeda Pharm's ALK-positive non-small cell lung cancer drug Alunbrig (Brigatinib), Tego science's sub-eye wrinkle improvement cell therapy Rosmir, soft tissue sarcoma drug Lartruvo (Olaratumab), Roche immune anticancer drug Tecentriq (Atezolizumab) and ALK-positive non-small cell lung cancer drug Alecensa (Alectinib), Pfizer's breast cancer drug Ibrance (Palbociclib) is also conditionally approved for phase III clinical trial. Hanmi’s Olita (Olmutinib), which was decided to discontinue marketing on September 30, 2016 due to a side effect of severe skin disease, also took the CMA track, and clinical trials are in progress even when the market is suspended. Eisai's Symbenda 25mg and 100mg are selected as treatments for which indications have been deleted due to failure to meet conditions such as submission of data for phase III clinical trials after CMA. Symbenda did not fulfill the condition and the indication was removed. GemVax & KAEL’s pancreatic cancer treatment Riavax was also delayed in submitting the result report for phase III clinical trials, so the MFDS decided to cancel its license. However, Samsung Pharm, who took over Riavax, objected to the disposition of the MFDS and applied for suspension of administrative disposition. Ilyang’s Supect (Radotinib) 100mg/200mg were also administered administratively. Pharmaceuticals that fulfilled the conditions for data submission in phase III include Boehringer Ingelheim's non-small cell lung cancer drug Giotrif (Afatinib) 20/30/40 mg, Amgen's bone giant cell tumor treatment Xgeva (Denosumab), Chong Kun Dang's CamTOBELL (Belotecan). For CMA drugs that have not completed the submission of data for phase III clinical trial, they are expected to submit final clinical results within the deadline reported to the MFDS. The MFDS is planning to actively approve the advancement of the CMA system by revising the internal guidelines and the handling of the CMA upgrade bill initiated by Jong-Heon Paik.
- Company
- Delstrigo seeks reimbursement to join the HIV drug market
- by Eo, Yun-Ho Feb 05, 2021 05:51am
- MSD’s HIV new drug Delstrigo has started the National Health Insurance (NHI) reimbursement application process. The pharmaceutical industry reported, MSD Korea has submitted an application for the NHI reimbursement on an once-daily fixed-dose combination tablet Delstrigo (doravirine / lamivudine / tenofovir disoproxil fumarate) treating human immunodeficiency virus type 1 (HIV-1). The South Korean authority approved Delstrigo as a treatment for HIV-1 infection in adults with no prior antiretroviral treatment experience. One of the combined agents, doravirine received South Korea’s Ministry of Food and Drug Safety (MFDS) approval as of Nov. 22, 2019, with a brand name of Pifeltro. The drug is indicated to be administered with another antiretroviral agent. Both Pifeltro and Delstrigo are indicated to treat HIV-1 infection in adults with no prior antiretroviral treatment experience. A Phase III DRIVE-AHEAD trial confirmed Delstrigo’s non-inferior efficacy compared to efavirenz (EFV)-emtricitabine (FTC)-tenofovir disoproxil fumarate (TDF). At week 48, 84 percent of the Delstrigo-administered patient group reached the viral suppression of HIV-1 RNA less than 40 copies/ mL, whereas 80 percent of the EFV-FTC-TDF group reached the level. As for clinical adverse reaction suspending the treatment, 3 percent and 6.6 percent of the patient groups reported adverse reactions, respectively, showing Delstrigo group had lower risk of adverse reactions. Currently, Gilead, GSK, MSD, Janssen, AbbVie and Bristol Myers Squibb (BMS) are competing in the HIV treatment market in South Korea, while Gilead and GSK are dominating 90 percent of the market share.
- 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.”
- Company
- Viatris’ Korean subsidiary has changed the name to Viatris
- by Feb 04, 2021 10:22am
- The Korean corporate name of the global healthcare company Viatris group will be officially changed to Viatris Korea from the 1st. Viatris’ Korean subsidiary (CEO: He-young Lee) was launched in November 2020 by combining Upjohn, a business division of global Pfizer, and Mylan, a global healthcare company. As the procedure for changing the domestic corporation name was recently completed, the company name changed from Pfizer Upjohn Korea to Viatris Korea from the 1st. Viatris is derived from the Latin words ‘via,’ meaning path, and ‘tris,’ which means three. Viatris Korea said, "The company's core value is expanding patient access to medicines, Leadership leading innovative healthcare solutions, and Trusted Partnership. We want to be a healthcare company that helps people live healthier in every stage of their lives." Viatris' major portfolio comprises more than 1,400 approved substances, including branded products, Rx drugs , generics, biosimilars, and over-the-counter (OTC) drugs for non-infectious and infectious diseases. Viatris Korea plans to provide quality treatments for non-infectious diseases such as cardiovascular, neuropathy, psychiatry, urology, and ophthalmology in the future, while reinforcing efforts for healthier lives for patients with non-infectious diseases. Based on the global product portfolio, it is planning to introduce various product portfolios and pipelines required by domestic patients such as new products in the field of infectious disease treatment including respiratory, biosimilars such as anti-cancer fields, and general medicines. An official from Viatris Korea said, "Viatris Korea provides innovative health solutions to patients and health care professionals, manages diseases and improves awareness, and provides various CSR (Corporate Social Responsibility) campaigns, including healthy aging campaigns. And we will contribute to the development of the healthcare industry and a healthy Korean society through various partnerships with the medical community, academia, government agencies, and NGOs."
- 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.
