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- 2025-12-23 05:25:56
- Policy
- “Will provide systemic support for homegrown mRNA vaccines"
- by Lee, Hye-Kyung Feb 11, 2022 05:55am
- The Ministry of Food and Drug Safety promised to spare no effort in providing institutional support so that domestic companies can foster mRNA vaccine manufacturing and development capabilities. On the 9th, Food and Drug Safety Minister Gang-lip Kim held a roundtable meeting with vaccine R&D developers and experts that are participating in the ‘mRNA Bio-venture consortium’ at Quratis’ production facility (Osong, North Chungcheong Province) to discuss measures to support the development of homegrown mRNA vaccines. Members from the Vaccine Center for Assisting Safety & Technology, Korea biomedicine Industry Association, Eyegene, Geneone Life Science, Quratis, Boryung Biopharma participated in the meeting. mRNA(messenger RNA) platform has been receiving much attention as an innovative platform for pharmaceutical development, as the technology may significantly reduce the time and cost required for manufacturing pharmaceuticals and can be applied to treat various diseases including cancer in addition to vaccines. The roundtable meeting was prepared for the government to listen to the needs in the field and discuss measures for support, as the MFDS plans to actively support the system and infrastructure necessary for developing the mRNA platform technology in Korea. At the meeting, vaccine developers and experts agreed that although securing the source technology is important for developing homegrown vaccines using mRNA technology, fostering professionals and implementing advanced regulatory science are most important for the commercialization of the vaccines. In other words, the industry asked for the MFDS’ continued efforts in advancing relevant regulations and fostering related personnel for the development of the biopharmaceutical industry. Minister Kim said, “Development homegrown mRNA vaccines is a must not only to overcome the current COVID-19 pandemic but to prepare for new epidemics and ensure public safety. We will spare no effort in providing institutional support so that domestic companies can foster mRNA vaccine manufacturing as well as development capabilities. Kim added, “We are committed to improving public health and will continue to conduct approval reviews based on expertise and regulatory science while fostering experts in the area. I ask you for your best efforts in developing domestic vaccines to protect the health and safety of our people.”
- Policy
- It's hard to handle free national support for self-diagnosis
- by Lee, Jeong-Hwan Feb 11, 2022 05:55am
- Prime Minister Kim Bu-Gyeom expressed disapproval of the ruling party's proposed "free support for self-diagnosis kits for the whole country." This is because the production of diagnostic kits is currently insufficient to cover free distribution across the country. On the 8th, Prime Minister Kim responded to a question from Rep. Shin Hyun-young of Democratic party of Korea in a comprehensive policy inquiry by the National Assembly's Special Committee on Budget and Settlement. On the same day, Rep. Shin asked, "The ruling party has argued that free supply to the whole country is needed." In fact, when the National Assembly's Health and Welfare Committee decided on the supplementary budget review on the 7th, the unit opinion said, "The government is considering supplying self-inspection kits to the entire nation." Demand for self-diagnosis kits has increased significantly recently as the government has implemented a quarantine policy that allows PCR tests only when positive results are obtained in rapid antigen tests. Prime Minister Kim said, "The production itself is difficult to cover the nation's free distribution of self-kits," explaining, "We made about 200 million kits a year, of which 100 million kits have to be exported, so there is a limit to production to free support with the rest." Regarding criticism that the government should adjust its own kit consumer sales price to less than 2,000 to 3,000 won, Prime Minister Kim replied, "The distribution process will also cost appropriate supply," adding, "We will decide with the MFDS and organize it quickly so that there will be no confusion." Meanwhile, according to the government, the current public sector procurement unit price per kit is about 2,350 won, and the market price is between 7,000 won and 8,000 won.
- Policy
- Following Kymriah, Zolgensma is also about to be reviewed
- by Lee, Tak-Sun Feb 09, 2022 06:09am
- Jang Yong-myung, executive director of HIRA development, briefing with reporters at Korea Special Press Association on the 8th So-called "one-shot treatments" that treat specific rare diseases with one administration are speeding up the reimbursement. Following Kymriah, which treats blood cancer such as leukemia and lymphoma, Zolgensma (Onasemnogene Abeparvovec), which treats a rare disease called SMA, is also set to be reviewed by HIRA's Drug Reimbursement Evaluation Committee. These drugs were difficult for patients to access because of their high price instead of high therapeutic effects, but if they are reimbursed, the burden of drug prices is expected to be relieved. Jang Yong-myung, executive director of HIRA Development, said at the Korea Special Press Association meeting on the 8th that Zolgensma will deliberate on the Drug Reimbursement Evaluation Committee to evaluate the adequacy of medical care benefits. Zolgensma is a drug that can treat spinal muscular dystrophy with a single dose. Spinal muscular dystrophy is a fatal rare genetic disease in which muscles are gradually contracted due to deficiency or mutation of normal SMN1 genes, and if not treated, 90% of SMA type 1 dies before the age of 2 or requires permanent respiratory aids. More than 30% of SMA type 2 patients can also die before the age of 25, requiring lifelong treatment. Zolgensma replaces genes that can prevent SMA progression, so it is expected to improve the quality of life of patients and their families as it can be fundamentally treated only once in a lifetime with intravenous administration. It is an ultra-high-priced new drug worth about 2 billion won, and it is too expensive for patients to handle, so being paid is the only hope for patients and their families. Accordingly, the solution found by the insurance authorities allows pharmaceutical companies to refund the amount paid to patients who was not effective. Executive Director Jang said, "Kymriah and Zolgensma are one-shot treatments that expect therapeutic effects from single administration, but there is a limit to proving cost effectiveness through existing evaluation methods due to high price and long-term uncertainty." "In the case of Kymriah, all patients who have been administered will be obligated to collect patient conditions for a certain period of time, and according to the results of the patient-level performance evaluation, pharmaceutical companies will refund a certain amount of money after administration," he explained. He also said, "If we claim more than a certain amount, we will pay on the condition of a contract that returns all excess amounts," adding, "We will be subject to risk-sharing revaluation after the fourth year of registration." Kymriah passed the Reimbursement Evaluation Committee on the 13th of last month under these conditions. As the adequacy of benefit has been recognized, it will now be possible if negotiations between the NHIS and pharmaceutical companies proceed smoothly. The HIRA plans to evaluate the adequacy of benefit in the same way as Kymriah or Zolgensma. Novartis applied for a decision on medical care benefits for Zolgensma in May last year and is currently being reviewed by the HIRA. It has been collecting opinions from the society since July last year, and at the end of last year, an expert advisory meeting was held to discuss clinical usefulness. At the end of January, the Drug Benefit Standards Subcommittee also reportedly set the benefit criteria. Executive Director Jang said, "Zolgensma is also considering a therapeutic performance-based refund mechanism to overcome the limitations of proving uncertainty and cost-effectiveness about long-term effects, just like Kymriah, as a drug that is effective with one administration."
- Policy
- Novavax vaccine passed the national lot release procedure
- by Lee, Hye-Kyung Feb 09, 2022 06:09am
- 840,000 doses of Nuvaxovid PFS, a Novavax vaccine, have been released in the national lot. The MFDS (Minister Kim Kang-rip) announced on the 8th that SK Bioscience has approved 840,000 Nuvaxovid PFS manufactured in Korea for the first time. Nuvaxovid PFS, which was approved for shipment to the country this time, is a vaccine manufactured in a way that has already been used for hepatitis B and cervical cancer vaccines. The vaccine can be immediately inoculated with a PFS-typed single injection that contains one dose per vaccine without dilution or subdividing, and the MFDS expects people to be vaccinated conveniently, such as being used for visits by elderly and severely disabled people. National Lot Release refers to a system in which the state comprehensively evaluates the results of the inspection test and the results of the manufacturer's manufacturing and testing for each manufacturing unit (lot) before the vaccine is distributed on the market. The MFDS verified the manufacturer's test method from 2021 for the national lot release of Nuvaxovid PFS, established its own test method, introduced equipment such as enzyme analysts, reviewed the manufacturing and test data for 840,000 times, and decided to release the national lot. As a result, Potency assay and content assay were conducted to confirm that the product was not contaminated by conducting sterility tests and endotoxin tests, and quality test data issued by the manufacturer's quality assurance manager were reviewed to produce consistent quality. The MFDS said, "We will continue to do our best to ensure that quality vaccines are stably supplied by quickly and thoroughly verifying the COVID-19 vaccine introduced in Korea." Information on the national lot release of the COVID-19 vaccine can be found on the COVID-19 vaccine and treatment information (www.mfds.go.kr) on the representative website of the MFDS.
- Policy
- Focus on the possibility of NovaVax vaccine booster shot
- by Lee, Tak-Sun Feb 08, 2022 05:55am
- Experts expressed great interest in the cross-vaccination use of the vaccine during the Novavax COVID-19 vaccine screening process approved in Korea on the 12th of last month. This is because Novavax is likely to be used for additional vaccinations, so-called booster shots, in a situation where most people have been vaccinated with different types of vaccines. However, the MFDS said that among the clinical data submitted by the company, there is a lack of valid data for cross-vaccination, and that cross-vaccination can be considered only when basic vaccination permission is given priority. Such information is recorded in the minutes of the Central Pharmaceutical Affairs Council released on the website of the MFDS on the 7th. Novavax was approved in Korea under the product name Nuvaxovid PFS on the 12th of last month. SK Bioscience receives technology transfer from Novavax and manufactures the vaccine from the undiluted solution to the finished product. It is the first gene recombination vaccine licensed in Korea, and is the fifth approved COVID-19 vaccine after AstraZeneca, Janssen, Pfizer, and Moderna. After the MFDS' self-examination, it was finally approved through a verification advisory group composed of experts, the Central Pharmaceutical Affairs Council, and the final inspection committee. Among them, the Central Pharmaceutical Affairs Council has the greatest impact on vaccine licensing. Fifteen external experts and eight officials from the MFDS attended the Central Pharmaceutical Affairs Council meeting held at 2 p.m. on the 6th of last month in the headquarters of the MFDS in Osong. Experts who attended that day asked about the evaluation of related efficacy, saying that the Novavax is likely to be used for additional vaccinations (booster shots) with the majority of Koreans receiving the existing vaccine. The MFDS said, "The difference between this applied vaccine and the existing one is a single-use PFS, and if it is not used within the deadline after opening as a multi-use vial, it should be discarded." The MFDS also said, "It is also advantageous in terms of compliance with administration as a vaccine for gene recombination platforms that have already been commercialized." Since the company announced plans to develop adolescents and additional vaccinations, the MFDS expressed expectations for youth use with low vaccination rates. In response, a member of the committee asked, "Is there any study conducted as an additional vaccination for vaccines on other platforms in foreign countries?" and the MFDS replied, "According to data released in the UK, additional vaccinations were made for companies D and B." The MFDS explained, "When additional vaccinations were given to those who completed the basic vaccination of Company D, they showed a higher immune response than those who received the virus vector vaccine." However, the MFDS said, "After deciding whether the safety and effectiveness of the applied vaccine can be recognized in terms of permission, the quarantine authorities will decide whether to use it by reflecting the current situation." The MFDS also stressed, "Additional vaccinations can be reviewed only when permission for basic vaccinations is decided first." Nevertheless, at the meeting, some suggested that an additional phrase "need to check cross-vaccination data later" is needed for Novavax permits. The MFDS replied, "In some cases, normal cross-vaccinations can be confirmed through the published results of other research institutes such as universities, and it is difficult for the company to submit all of them." As a result, the committee agreed to approve the Novavax as "for use twice every three weeks for those aged 18 or older," but did not conclude separately regarding cross-vaccination. Meanwhile, the Novavax is expected to begin vaccination for unvaccinated patients at each hospital and clinic soon after approval from the MFDS.
- Policy
- HPV vaccine expanded free vaccination for men and women
- by Lee, Jeong-Hwan Feb 08, 2022 05:54am
- It is estimated that about 200 billion won will be spent over the next five years to expand the national vaccination target of HPV vaccination to children aged 11 and 12 regardless of gender. Assuming that the target vaccination rate is 89%-100%, an annual average budget of about 40 billion won is needed. This is the result of Baek Jong-heon, a member of the National Assembly, entrusted with the cost estimation of some revisions to the Infectious Disease Prevention and Management Act proposed by the National Assembly's Budget Office on the 4th. Baek Jong-heon proposed a bill to expand the subject of HPV national vaccination (NIP) to children aged 11 and 12 regardless of gender. As a result of the cost estimation by the Ministry of Budget and Policy, a total budget of 2015 billion won to 210.5 billion won will be needed depending on the target vaccination rate. Specifically, the current HPV vaccine NIP is inoculating 12-year-old women. Accordingly, in the first year of implementation of the amendment, the cost of inoculation for 11-year-old women was estimated, and from the second year of implementation, the cost of inoculation for women was excluded from the estimation. The target vaccination rate was estimated by dividing it into two scenarios because the inoculation rate of 89.6% and 100% in 2020 were separately counted. The vaccine cost was 62,200 won for HPV4 at the public health center, reflecting the average increase in the number of vaccines over the past three years (2019-2021). As a result of the estimation, a total of 2015 to 210.5 billion won was estimated from 2022 to 2026 when HPV vaccinations were conducted for 11-year-old women and men aged 11 to 12 according to the revision of Baek Jong-heon. In the case of scenario 1 with an 89.6% vaccination rate, a total of 201594 billion won will be required for five years from 2022 to 2026, including 79.242 billion won in 2022 and 30.736 billion won in 2026. When the inoculation rate was estimated to be 100% scenario 2, it was estimated to be 210.512 billion won for five years from 2022 to 2026, including 88.439 billion won in 2022 and 30.787 billion won in 2026.
- Policy
- Generics for Bridion are being released one after another
- by Lee, Tak-Sun Feb 07, 2022 05:58am
- Generic drugs are being released one after another ahead of the patent expiration in April, with the drug Bridion (Sugammadex Sodium, MSD), which helps wake up from anesthesia during surgery. As the domestic market size of the drug alone is around 40 billion won, domestic generic companies are expected to aggressively target the market. According to the MFDS on the 6th, six generics of Sugammadex Sodium have been approved so far since Hanlim was first approved on December 29 last year. Bridion is a drug that directly acts on the relaxation of the muscles used for patient anesthesia and restores them to their original state. In patients over the age of 2, it is used in reverse of neuromuscular blocking induced by Vecuronium or Rocuronium. These are muscle relaxants used for patient anesthesia during surgery. Bridion, approved in Korea in October 2012, is also a new anesthetic antagonist drug that came out in 20 years. In particular, this drug is widely used because it can provide a stable surgical environment to medical staff in that it acts directly on muscle relaxants and acts within 3 minutes. Existing drugs were indirectly applied to muscle relaxation drugs, resulting in slow recovery of relaxed muscles. Bridion's rapid action not only enhances surgical stability, but also relieves concerns about muscle relaxation remaining after surgery. In particular, existing anesthetic antagonists have the advantage of being used even for patients with respiratory or cardiovascular diseases that are highly likely to have side effects. With this differentiation, Bridion is maintaining high growth in the domestic market. In the second quarter of last year based on IQVIA, its performance was 11.2 billion won. The drug, which recorded 39.1 billion won in sales in 2020, is said to have surpassed 40 billion won last year. Market sales were so high that other generic companies also paid attention early on. However, material patents are valid until April 12 this year. Since 2018, pharmaceutical companies such as Daewoong Pharmaceutical and Chong Kun Dang have been challenging patents, but all of them have been dismissed by the Intellectual Property Tribunal. As the patent expiration time is imminent, generic drugs are preparing to be released with permission. First of all, Hanlim was approved for the first generic under the product name Briturn on December 29 last year. In January, products from Sandoz Korea, BMI Korea, and Huons were approved. On the 4th, Boryung Pharmaceutical and Jeil Pharmaceutical were then approved by Huons for items that were commissioned. These generic drugs are expected to be released on the market from April 13, when patents are terminated. As it is such a large-scale drug in the market, expectations for sales performance are high, but the prevailing opinion is that it will be difficult to win the competition of the original drug. In the case of general hospitals that perform a lot of surgery, the reliability of original is much higher. It remains to be seen whether generic drugs will overcome this and set meaningful records in terms of market share.
- Policy
- 1 ‘Soliris’ and 4 ‘Ultomiris’ cases seek prior approval
- by Lee, Hye-Kyung Feb 07, 2022 05:57am
- The 3 applications filed for preliminary approval of reimbursement to use ‘Ultomiris (ravulizumab)’ in new patients with paroxysmal nocturnal hemoglobinuria (PNH), and 1 application for re-deliberation were approved, and 2 cases of appeals that were filed were dismissed by Health Insurance Review and Assessment Service’s Healthcare Review and Assessment Committee. In the same disease class, no new applications were filed for newly reimbursed administration of ‘Soliris (eculizumab),’ but 1 of the new preliminary approval applications filed for reimbursement in new patients with atypical hemolytic uremic syndrome (aHUS) was approved. This January, the Healthcare Review and Assessment Committee deliberated cases for Soliris, Ultomiris, mid-to-long-term hospitalization due to external injury, etc., mid-to-long-term hospitalization for pain control, short-term hospitalization due to external injury, F-18 FDG PET for liver cancer, internal nasal splints used for endoscopic transnasal transsphenoidal hypophysectomy of pituitary tumor, ventricular assist device treatment, medical and selective insurance benefit for hemopoietic stem cell transplantation, and medical insurance benefit for immune tolerance induction therapy. Results that were disclosed on the 4th show that for Soliris, 22 PNH monitoring requests were approved, 1 new request for aHUS indication approved, 4 disapproved, 1 re-administration approved, and 4 monitoring cases approved. For Ultomiris, 3 requests to reimburse new patients with PNH were approved, 1 re-deliberation approved, and 2 appeals were dismissed. Soliris, which has an insurance cap of 5,132,364 won per vial (30ml), costs around 400 million won per year in drug expenses if 3 vials are administered bi-weekly for a year. Ultomiris was listed for reimbursement at 5,598.942 won per vial on June 7th last year, and patients must receive a maintenance dose every 8 weeks 2 weeks after receiving the initial dose. As Soliris and Ultomiris are both ultra-high-priced drugs, a preliminary approval system is conducted to determine eligibility for medical care benefits. Institutions that apply for the preliminary approval must administer the said Soliris or Ultomiris within 60 days of receiving notification of the deliberation results, and must resubmit an application if it wishes to administer the drugs after 60 days. Also, the long-term care institutions that receive the approval for Soliris or Ultomiris’s medical care benefit need to submit a monitoring report every 6 months, with those using Soliris for aHUS being required to additionally submit initial monitoring reports 2 months into treatment. Further details of the deliberation can be found on HIRA’s website (www.hira.or.kr) or business portal (biz.hira.or.kr.>comprehensive review criteria service > criteria > review criteria > Open deliberation cases).
- Policy
- Janssen Korea has obtained permission
- by Lee, Tak-Sun Feb 04, 2022 05:56am
- Janssen Korea has been approved by the MFDS for Pharmaceutical Consignment Permission for Manufacturing Business. This can be interpreted as part of the withdrawal of the Hyangnam plant. If Janssen Korea completely withdraws its Hyangnam plant, there will be no Janssen Korea plant facilities in Korea. The MFDS approved the "Manufacturing Business" of Janssen Korea as of the 26th. Drug consignment Manufacturing Business does not have domestic production facilities, but is granted to companies that are licensed for manufacturing items through consignment manufacturers. So far, 11 companies have received it. Among the nation's history, GL Pharm Tech , Corepharmbio, Crystalgenimics, Gunkang, Woosung,iN Therapeutics received a permit, and multinational pharmaceutical companies, including Organon Korea, Abbott, AstraZeneca, Moderna Korea and Janssen Korea. Janssen Korea's acquisition of a pharmaceutical consignment manufacturing and sales business is linked to the withdrawal of its Hyangnam plant. Janssen Korea stopped operating its Hyangnam plant last year. When the acquisition process is completed in the future, the factory will be used by Whanin. Janssen Korea is organizing items following the suspension of its Hyangnam plant. There are nine Janssen's remaining manufacturing permits. Among them, three items are for export and three items are commissioned and manufactured by Handok. Domestic sales items manufactured by themselves are organized into Tylenol 80mg for children, Tylenol 160mg for children, and Tylenol suspension. In the case of children's Tylenol suspension, the MFDS has currently applied for the withdrawal of permission. The remaining 80 items approved by Janssen Korea are all imported finished products. In the case of Ultracet Semi, Ultracet ER, and Ultracet ER semi, technology transfer to Handok is being produced on consignment, so Janssen needed permission to "consignment manufacturing and sales" even if the factory was withdrawn. There are two domestic pharmaceutical production facilities for multinational pharmaceutical companies: Otsuka Pharmaceutical Korea (Hyangnam Plant) and Janssen Vaccine (Songdo Plant).
- Policy
- 45 generics of Dapagliflozin+Sitagliptin were approved
- by Lee, Tak-Sun Feb 03, 2022 05:57am
- MSD Dapagliflozin+Sitaglipin from 45 companies, which can only be sold in September next year, has been approved. Analysts say that the number of licensed companies is increasing as Dongkoo and Daewon, which succeeded in developing products, start supplying generics. On the 28th, the MFDS approved 13 additional items of Dapagliflozin+Sitagliptin. As a result, the number of Dapagliflozin+Sitaglipin increased to 45. Forxiga is an SGLT-2 inhibitory diabetes treatment and has recently grown rapidly in the diabetes treatment market. Forxiga, the original drug, recorded 42.6 billion won in outpatient prescriptions (based on UBIST) last year. Januvia has long been leading the market with DPP-4 inhibitory drugs. MSD's Januvia recorded an outpatient prescription of 459 won last year. Two single drugs are widely used as diabetes treatments, and they are often used in combination. Therefore, it is analyzed that when a combination of the two ingredients is released, the convenience of taking them will increase, and the prescription performance will increase. Due to this expectation, it is interpreted that there were many requests for the production of consigned items from Daewon and Dongkoo. So far, a total of 15 items have been approved by Daewon, including the company, and a total of 30 items have been approved by Dongkoo. Daewon's Dapacombi 10/100mg and Dongkoo's Sitaflozin 10/100mg were approved, respectively, in December last year. Both drugs are the first combinations to contain Dapagliflozin 10mg and Sitagliptin 100mg. These drugs are believed to have signed contracts and applied for permission before July last year when the consignment BA restriction system was implemented. However, these products are not immediately available for sale. Both ingredients cannot be sold to the market before September 2023 because the material patents have not expired. At the same time, there is no standard for insurance benefits for the SGLT-2+DPP-4 complex. However, insurance benefits applied by the existing licensed complex systems are expected to be completed soon, so it is expected that insurance benefits will be easily obtained before the launch in September 2023.
