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- 2026-05-18 18:57:47
- Policy
- Over 40mil COVID-19 vaccines cleared for release in 6 mos
- by Lee, Tak-Sun Aug 23, 2021 05:55am
- Ministry of Food and Drug Safety The number of COVID-19 vaccines granted National Lot Release in Korea has exceeded 40 million. The large-scale batches of Pfizer vaccines introduced in late July have accelerated the number of vaccines approved for lot release. According to the Ministry of Food and Drug Safety on the 22nd, 1.6 million doses (for 800 thousand people) Pfizer Korea’s ‘Cormirnaty inj. (tozinameran)’ were approved for National Lot Release on the 20th. The cumulative number of doses approved reached 41.263 million with the release, exceeding 40 million doses for the first time in 6 months since the first lot of COVID-19 vaccines were released on February 17th. The National Lot Release system is the final quality inspection system conducted by the MFDS before releasing appropriate products for marketing approval. Only COVID-19 vaccines that were officially approved are counted, and vaccines supplied by COVAX Facility or from other countries are not subject to the national lot release. With vaccinations now in full scale for people less than 50 years of age in Korea, most of the vaccines approved for lot release are Pfizer vaccines. Over 1 million doses of the Pfizer vaccine have been supplied since the end of July. 코로나19백신 국가출하승인 현황(식약처 자료 발췌) However, the amount approved for national lot release and the number of people vaccinated differ. The use of vaccines that did not go through the national lot release system and the use of the low dead space syringe has increased the number of those vaccinated. According to the Korea Disease and Prevention Agency, 25,866,970 people received their first vaccination, and 11,562,518 people completed vaccinations as of 22nd, 12:00 p.m. In other words, 50.4% of the population has received the first dose, and 22.5% of the population has been fully vaccinated. Among those that received the first dose of the COVID-19 vaccine, 10,836,390 received the AstraZeneca vaccine, 11,620,319 received the Pfizer vaccine, 2,280,477 received the Moderna vaccine, and 1,129,784 received the Janssen vaccine. Only 101,000 doses of the Janssen vaccine were approved through the National Lot Release, however, much more people were able to be vaccinated with Janssen vaccines that were provided by the U.S., which did not pass through the National Lot Release system. A total of 2,454,000 doses of the Moderna vaccine, which had seen a disruption in supply recently, were approved through the National Lot Release system. Currently, the Korean Ministry of Food and Drug Safety has approved 4 COVID-19 vaccines from AstraZeneca, Pfizer, Janssen, and Moderna.
- Policy
- Perjeta's price was down 10% to ₩2,214,600
- by Kim, Jung-Ju Aug 23, 2021 05:55am
- Five drugs that succeeded in insurance benefits in Korea due to Risk Sharing Agreement (RSA) have been re-contracted by lowering drug prices to the expiration of the contract. According to the industry, the MOHW is recently pushing to revise the list of drug benefits aimed at the 1st of next month for a total of five successful drugs negotiated by the NHIS and the pharmaceutical companies. The drugs are Roche Korea's Perjeta (Pertuzumab) and Novartis' Meqsel (Trametinib Dimethyl Sulfoxide) , which will reduce existing drug prices by at least 0.5% and at most 10%. Perjeta's prices were down 10% from ₩2,465,60 to ₩2,214,600. The price of Meqsel will be reduced from ₩128,344 to ₩127,639, and Meqsel 0.5mg will be lowered from ₩32,086 to ₩31,910, respectively.
- Company
- Accumulated exports of K-Biosimilars reach ₩9Tril
- by Chon, Seung-Hyun Aug 23, 2021 05:55am
- Cumulative exports of biosimilars developed by Celltrion and Samsung Bioepis exceeded ₩9 trillion. Growth has slowed compared to the products’ first market entry, however, the products have been marking stable growth based on their solid pipeline. ◆Celltrion Healthcare exports ₩789.5billion in H1…cumulative sales exceed ₩6 trillion According to the Financial Supervisory Service on the 19th, Celltrion Healthcare’s exports reached ₩789.5 billion, a 1.6% increase from the ₩777.2 billion in the same period last year. Although growth was not as explosive as in the previous year, the company still recorded large-scale overseas exports. Celltrion Healthcare is an affiliate of Celltrion that has Celltrion Healthcare Holdings (share 24.3%) as its largest shareholder. Celltrion Healthcare sells antibody biosimilar products that it received from Celltrion to global distributors. In other words, Celltrion Healthcare’s sales refer to the export performance of biosimilars developed by Celltrion. Celltrion Healthcare is selling 4 biosimilar products including ‘Remsima,’ ‘Truxima,’ ‘Herzuma,’ and ‘Remsima SC’ in the global market. Remsima’s original is Janssen’s ‘Remicade.’ Remsima SC is a subcutaneous injection formulating of Remsima. Truxima and Herzuma are biosimilars of ‘MabThera’ and ‘Herceptin,’ respectively. By each product, Remsima sold the most in exports, recording ₩302.1 billion in H1 this year. Adding Remsima SC(₩35.1), the Remsima brand sold ₩337.3 billion in exports in H1 this year. Remsima is the first biosimilar product that was approved in 2012. It had annually recorded the highest export sales among all Celltrion’s biosimilars but was outrun by Truxima’s record of ₩786.8 billion last year. However, this year, sales of Remsima again surpassed that of Truxima and became the No.1 product in exports. Truxima’s export sales fell 25.3% YOY from ₩365.8 billion to ₩273.3 billion in H1 this year. The company explained that Truxima’s sales in Q1, which saw a 32.6% YOY decrease to mark ₩109.7 billion, was due to a temporary adjustment in the supply schedule of its products. Herzuma’s export sales in H1 this year were ₩102.3 billion, a 25.7% YOY increase. Herzuma’s share in the European market in Q1 was 15%, a slight decrease from the 19% it held in Q1 last year. However, in the Japanese market, its share exceeded that of its originator Herceptin, to record 50%. This was more than a twofold market expansion in a single year from the 25% share it held in Q1 last year. Celltrion Healthcare, which was listed on KOSDAQ in 2017, has been recording its export performance in its business report since 2014. Since 2014, Remsima and Remsima SC have recorded the most in exports with a cumulative record of ₩3.7123 trillion. Truxima, which started making export performance in 2017, marked ₩1.9925 trillion, and Herzuma’s cumulative exports amounted to ₩575.1 billion. On whole, Celltrion Healthcare’s cumulative exports from 2014 to H1 this year marked ₩6.3 trillion. ◆Samsung Bioepis makes ₩354.2 billion in H1… cumulative sales record ₩2.0889 trillion Samsung Bioepis’s operating profit last year was ₩145 billion, an 18.1% YOY increase from the same period of the previous year. Since it recorded its first profit in 2019 with ₩122.8 billion, its profit has grown even more in a single year. Samsung Bioepis recorded ₩187.5 billion in sales in Q2, which is a 22.7% YOY increase. The company had continued on a downward roll since Q3 of last year, when it recorded its all-time high with ₩236.9 billion, however, in only 2 quarters since then, the company has recovered its performance to a level similar to its pre-COVID-19 performance. The accumulated sales of Samsung Bioepis in the 1H of this year rose 5.5% compared to the same period of last year, to record ₩354.2 billion Most of its sales were generated from overseas sales of the company’s self-developed biosimilars. Samsung Bioepis had succeeded in commercializing 5 biosimilars of biopharmaceuticals – ‘Enbrel,’ ‘Remicade,’ ‘Herceptin,’ ‘Humira,’ and ‘Avastin.’ In the global market, the company has signed marketing partnership agreements with multinational pharmaceutical companies such as Biogen and Organon to sell its products. Biogen is in charge of the local distribution and sales of the three autoimmune treatments, ‘ Benepali,’ ‘Flixabi,’ and ‘Imraldi.’ Organon (formerly known as MSD) is selling the three products in countries other than the U.S., Korea, and China, as ‘Renflexis (Remicade biosimilar), ‘Brenzys (Enbrel biosimilar),’ ‘Hadlima (Humira biosimilar).’ Organon is also in charge of selling the two anticancer drugs - the Herceptin biosimilar ‘Ontruzant’ and Avastin biosimilar ‘Avincio’ – abroad. According to performance reports by Biogen and Organon, biosimilars of Samsung Bioepis had made $573 million (approximately ₩675 billion) in H1 this year. Sales made by Biogen rose 4.3% YOY to record $407 million (approximately ₩470 billion). Sales made with biosimilars through Organon were $166 million (approximately ₩195 billion). Although the drugs sold less in comparison to its performance in the European market, its growth of 43.4% YoY has been received positively due to its growth potential. Due to the preorders that were made in Q1, sales in Q2 had decreased, then rose sharply in the second half of the year with the technology fee (milestone payments) from signing biosimilar license agreements with Chinese companies such as S Bio and C-Bridge Capital in 2019 being reflected in the revenue. This year, sales have stabilized to record ₩166.7 billion in Q1 and ₩187.5 billion in Q2. Samsung Bioepis, which was established in 2012, had shown full growth since recording ₩147.5 billion in sales in 2016. Last year, sales increased over fivefold compared to four years ago. Since its launch in 2012, Samsung Bioepis has recorded a cumulative sales of ₩ 2.8895 trillion. Most of Samsung Bioepis' sales come from overseas sales of biosimilars or technology fees. Its domestic sales contributions are small compared to exports. In other words, Celltrion and Samsung Bioepis’ combined exports of biosimilars recorded over ₩ 9 trillion in total.
- Policy
- AstraZeneca vaccine has been approved in 121 countries
- by Lee, Tak-Sun Aug 23, 2021 05:55am
- The most widely approved coronavirus vaccine in countries around the world was AZD1222, co-developed by AstraZeneca and Oxford University. AZ vaccine was the first approved COVID vaccine in Korea in February. According to the MFDS, the KOBIA, abd the national vaccine safety technology support center, AZ vaccine was approved in 121 countries around the world, with the largest number of licensed countries among COVID-19 vaccines. AZ vaccine has been tested in the largest number of countries, with 35 clinical trials in 19 countries. Developed by Pfizer and BioNTech, BNT162b2 has been licensed in 97 countries around the world. It was also granted the second COVID-19 vaccine in Korea following AZ in March. Pfizer vaccine was found to have carried out 31 clinical trials in 17 countries. The third most licensed vaccine was Sputnik V, developed by Russia's The Gamaleya Research Institute of Epidemiology and Microbiology, which was licensed in 70 countries. It is a product that has not yet been licensed in Korea, and Huons, which produces the vaccine on consignment, applied for a preliminary review before applying for permission in April. Unlike AZ and Pfizer vaccines, Sputnik V did not receive WHO's Emergency Use Authorization. The fourth most licensed vaccine is Moderna's mRNA-1273 vaccine, which has been approved for use in 65 countries. Moderna vaccine was approved in May in Korea. It was approved in the order of Ad26.COV2.S (59 countries), Sinopharm's BBIBP-CorV (53 countries), India's Serum Institute's Covishield (45 countries) and Sinovac's CoronaVac' (32 countries). In Korea, a total of four types of vaccines, including AZ, Pfizer, Modena and Janssen, have been granted, and vaccinations are underway. The WHO's EUA includes seven vaccines: Moderna, Pfizer, Janssen, AZ, Serum Research Institute, Sinopharm and Sinovac. The WHO's Emergency Use Authorized vaccines can be used by reference to countries that have difficulty in screening drugs alone.
- Policy
- Women under the age of 17 will be given Gardasil 9 for free
- by Lee, Jeong-Hwan Aug 23, 2021 05:55am
- President Moon Jae-in is answering directly to celebrate the 4th anniversary of the petition. He promised the government will expand the scope of free cervical cancer vaccinations from women under the current age of 12 to under the age of 17 so that all women and teenagers can receive free vaccination benefits. He said he would also make efforts to expand the workforce and improve the working environment and treatment of nurses at health centers who are responding to COVID outbreak. On the 19th, President Moon directly responded to the public to mark the 4th anniversary of the petition. President Moon has declared more support for cervical cancer vaccinations. This is the answer to 18,817 people's petition to oppose the increase in the amount of the cervical cancer vaccine Gardasil 9 and to apply insurance premiums. There are a total of 48 requests for cervical cancer vaccine support. The standard is to respond when more than 200,000 people agree, but President Moon said, "A small number of agreements does not mean less important." President Moon said, "Cervical cervical cancer is the only cancer that can be prevented by vaccination, but it is often not vaccinated due to the cost of up to ₩600,000." He said, "We will expand the scope of free vaccination for cervical cancer from women under 12 to under 17 years of age and receive free benefits for all female teenagers." President Moon said, "We will allow low-income women aged 18 to 26 to receive free vaccinations and gradually expand the scope." It also mentioned hiring nurses and improving treatment at health centers, which are essential workers in response to COVID-19. 65,385 people have joined the petition to prevent nurses at health centers from collapsing. "We have hired 1,273 nurses in the first half of this year, and we are hiring 2,353 more people to respond to infectious diseases this month," President Moon said. "We will continue to expand the number of nurses and improve the working environment and treatment." In addition, President Moon promised to expand medical support for the infertility and strengthen support for vacation, preferential vaccination of COVID to caregivers and delivery call centers and visiting service workers. Furthermore, President Moon announced his plan to introduce a system that will allow government agencies such as the National Assembly, courts, Constitutional Court and the National Elections Commission to file petitions online at the end of next year.
- Policy
- Lyrica CR generics begin development...PMS expires next July
- by Lee, Tak-Sun Aug 20, 2021 05:56am
- Development for generics of Pfizer’s pain reliever ‘Lyrica CR,’ whose post-market surveillance (PMS) period expires in July next year, has begun. Unlike Lyrica, which is taken twice a day, Lyrica CR is a once-daily formulation and is used for peripheral neuropathic pain in adults. With more than 80 pharmaceutical companies participating in the development of Lyrica generic, attention is focused on whether such avid interest will be shown for Lyrica CR as well. On the 17th, the Ministry of Food and Drug Safety approved the bioequivalence study protocol for Dasan Pharmaceutical’s DSP2102. The study will assess the bioequivalence of Dasan Pharmaceutical’s ‘DSP2102’ and Pfizer Pharmaceuticals Korea’s ‘Lyrica CR 300mg’ on 34 healthy adult participants. Dasan’s study will be the first to compare a drug with Lyrica CR. The PMS period for Lyrica CR, which was approved in July 2018, will expire in July next year. The move to conduct bioequivalence tests for the development of generics has begun as approval for generics is possible upon expiry of the PMS period. Lyrica is a leading product in the domestic pain reliever market. Lyrica sold 52.9 billion won according to IQVIA last year. However, Lyrica CR’s performance is not as significant as Lyrica’s as it has been released relatively recently, has a limited indication, and has viable competitors. In the same period, Lyrica CR only made 700 million won in sales. However, when considering that around 80 generic companies entered the market after Lyrica’s substance patent expired in 2012, the possibility remains that latecomers in the field will show an interest in the more convenient, less frequently taken Lyrica CR. However, with market competitors already existing in the market and new regulations in place for development, the number of companies jumping in to develop Lyrika CR generics is expected to be less than that for Lyrica. Six other companies including Yuhan Corp. own once-daily drugs containing the same ingredient as Lyrica CR. The products entered the market only a few months after the original, and the companies have been enjoying the first-mover advantage. Also, due to the restriction limiting each consigner to share its bioequivalence tests with only three consignees, the burden of companies needing to develop generic drugs themselves will have an effect in reducing the number of products seeking market entry. The use of Lyrica CR is limited compared to Lyrica, as it can only be used to treat peripheral neuropathic pain in adults. On the other hand, Lyrica is additionally indicated for epilepsy (as adjunctive therapy for partial-onset seizures with or without secondary generalization) and fibromyalgia.
- Company
- Novartis starts reimbursement discussions for Zolgensma
- by Eo, Yun-Ho Aug 20, 2021 05:56am
- After ‘Kymriah,’ Novartis has now begun the reimbursement listing process for ‘Zolgensma.' According to industry sources, the application for the reimbursement of Novartis Korea’s Zolgensma (onasemnogene abeparvovec-xioi) that was submitted through the approval-benefit appraisal linkage system will be put on the agenda for deliberation by the Central Review Adjustment Committee in coming September. As a result, Novartis, which already has Kymriah (tisagenlecleucel) set for review by the Cancer Disease Review Committee (CDRC) on September 1st, will be working with the government to list two of its blockbuster drugs for reimbursement benefit in September. And the industry's eyes are focus on whether and how the two drugs will be listed for insurance benefits. Zolgensma is a treatment for Spinal Muscular Atrophy (SMA), like ‘Spinraza (nusinersen)’ that was approved in 2017, and is a gene therapy that contains a genetic material that functionally replaces defective genes. The Ministry of Health and Welfare had approved Zolgensma as the second advanced biopharmaceutical after Kymriah. Advanced biopharmaceuticals are cell therapies or gene therapies that use live cells, tissues, or genetic material as ingredients. Under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals,’ advanced biopharmaceuticals can receive differentiated safety management including long-term follow-up studies and support for R&D and product commercialization. Despite being a one-shot treatment, the price of a single-shot of Zolgensma costs 2.5 billion won in the U.S. and 1.89 billion won in Japan. Due to this high price, the reimbursement approval process for Zolgensma in Korea is also not going to be easy. However, expectations on the drug's efficacy are very high. The Phase III SPR1NT and STR1VE-EU results for Zolgensma that was recently presented had received much attention to that effect. In the SPR1NT study, all pediatric SMA patients with two SMN Type 2 gene copy (Cohort 1) that were treated pre-symptomatically survived without requiring ventilatory or nutritional assistance, and achieved sitting independently for 30 seconds or more. Most (11/14) patients achieved age-appropriate motor milestones within the World Health Organization (WHO) window of normal development. In the STR1VE-EU study, most pediatric patients (82%) that were treated with Zolgensma, including those with severe SMA, achieved motor milestones unseen in the natural history of SMA Type 1. Zolgensma is indicated in Korea for the treatment of pediatric patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) who ▲ have been clinically diagnosed with SMA Type 1 or ▲ has up to 3 copies of the SMN2 gene.
- Policy
- The current health insurance premium increase rate is 2.91%
- by Lee, Hye-Kyung Aug 20, 2021 05:56am
- Health authorities have refuted allegations that health insurance premiums have been raised for the success of health insurance policies. The MOHW and the NHIS recently released a statement by the Korea Enterprises Federation (KEF) explaining that "reorganization, including a cap on health insurance premiums, is a reasonable and fair result of social consensus." The KEF said in a report that Japan and Taiwan, which have similar systems to Korea, have a higher upper limit on domestic health insurance premiums than other countries, with a gap of about 24 times and 12 times, respectively. The NHIS explained, "Health insurance is based on the principle of social solidarity, a social insurance system in which subscribers premiums, and anyone, regardless of income level, receives medical benefits as needed." The NHIS explained, "In Korea, as a single national health insurance, the insurance upper limit is institutionalized as income redistribution and social solidarity are emphasized, and the insurance upper limit is the result of social consensus that reflects the history of the national system and people's perception." In France, the health insurance premium rate reaches 13% (full copayment of patient), but the higher the wage level due to the lack of an upper limit, the greater the user's health insurance premium. The upper limit of insurance premiums is part of a reform of the health insurance premium system, and discussions have begun to cope with the heavy burden on low-income local subscribers. "It is based on years of social discussion and the agreement between the ruling and opposition parties to increase the equity of insurance premiums," the NHIS said. "It is planned to reorganize the imposition system of Step 1 in July 2018 and revise the effect of Step 1 in July 2022. In the process of promoting Moon Jae-In Care, the health insurance premium rate is 2.91%, which is lower than the average of 3.20% over the past decade (2007-2016), and the NHIS said, "As of 2021, the health insurance premium rate is 6.86%, France (13%), Germany (14.6%), and Japan (9.21-10.0%)." The NHIS said, "The health insurance premium rate for next year has not been determined, and it will be decided through social consensus after sufficient discussion by the Health Insurance Policy Committee, which includes all members, suppliers, and public interest members."
- Policy
- Seven companies are supplying flu vaccines this year
- by Lee, Tak-Sun Aug 20, 2021 05:55am
- SK Bioscience will focus on COVID vaccine after consulting with the KDCA. The market share of the GC Pharma is likely to increase. Two imported vaccines including Sanofi and GSK Flu vaccines, which will be distributed and sold in Korea this year, are nine items from seven companies, down three from the previous year. SK Bioscience, which had the highest sales performance of flu vaccines last year, will not supply them this year due to the production of COVID-19 vaccine, and Dong-A ST and LG Chem have also been excluded from the market. According to the MFDS on the 17th, domestic manufacturers that distribute flu vaccines this year are Boryung Bio (2 items), Boryung, GC Pharma (2 items), Il Yang (2 items), and the importers are Sanofi Pasteur and GlaxoSmithKline. Compared to last year, SK Bioscience, Dong-A ST, and LG Chem were excluded. SK Bioscience has been unable to distribute flu vaccines in Korea this year due to the production of COVID vaccine. SK Bioscience is commissioning and producing AZ and Novavax vaccine and is also developing its own products. A company official said, "The existing production line of the flu vaccine at Andong plant is producing COVID vaccines, in consultation with the KDCA, we decided not to supply flu vaccines this year." SK Bioscience recorded the highest performance in Korea last year, with production of only 4-valent flu vaccine worth ₩164.7 billion. As SK Bioscience is out this year, only two companies that produce raw material to finished products in Korea will remain: GC Pharma and Il Yang. The share of GC Pharma, which recorded the second highest production performance of ₩82.9 billion after SK Bioscience last year, is expected to increase significantly. In the case of Dong-A ST, the company received the original amount from Sanofi and manufactured and supplied the finished product, but due to the expiration of the contract, Vaxiflu Tetra Injection Solution Prefilled Syringe was revoked in January. LG Chem, which receives products from GC Pharma, is not selling flu vaccines this year. Like last year, Sanofi Pasteur and Glaxosmithkline distribute imported vaccines. However, Sanofi Pasteur participates in NIP for children and pregnant women under the age of 13. It is explained that the mandatory vaccination for national procurement aged 65 or older was not available because it was difficult to meet the supply schedule suggested by the KDCA. It is known that importers such as GSK do not actively participate due to the same low cost of the national mandatory vaccination project as last year. The MFDS predicts that about 28.8 million flu vaccines will be distributed this year. Among them, 14.6 million people were involved in the NIP project. Last year, National lot releases for 29 million people were distributed. As of the 13th, the national lot release for 3.66 million people was received.
- Policy
- Hanmi's Suvast 2.5mg has been approved
- by Lee, Tak-Sun Aug 19, 2021 06:03am
- There was no Rosuvastatin 2.5 mg available.Hanmi has started to create a new market by pushing for the approval of combination drug. The MFDS approved Hanmi's Suvast 2.5mg on the 17th. It is Rosuvastatin 2.5mg, which is not released in Korea. It is used in primary hypercholesterol and complex hyperlipidemia. Ministry of Health, Labour and Welfare of Japan recommends Rosuvastatin 2.5mg to Asians with smaller body types. According to indications of Suvast 2.5 mg, the recommended initial dose is 2.5 mg or 5 mg because of increased systemic exposure to Asian patients. Previously, if Rosuvastatin 5mg was used for initial dose, the drug choice that can be used with 2.5mg was increased. Hanmi is known to be planning to market Rosuvastatin 2.5mg strategically. Hanmi is also pushing for the approval of combination drug containing Ezetimibe. It is said that in April, it applied to the MFDS for approval of Rosuzet 10/2.5 mg (Rosuvastatin 2.5mg / Ezetimibe 10mg). Rosuzet posted ₩99.1 billion in outpatient prescription sales last year alone. It is expected to focus on Suvast 2.5mg, and drugs containing Rosuvastatin 2.5mg in Korea. As a result, it is expected that it will emphasize that the amount of Rosuvastatin 2.5mg is more suitable for Koreans with its initial dose. Hanmi conducted phase 3 of Ezetimibe/Rosuvastatin 10-2.5 mg dose group (N=68), this drug (Rosuvastatin 2.5 mg) dose group (N=67), Ezetimibe 10 mg dose group (N=70), and Rosuvastatin 5 mg dose group (N=70) for 8 weeks in 275 patients with primary hypercholesterol. In the primary validation, the LDL-C change rate (%) in this drug (Rosuvastatin 2.5 mg) administration group decreased statistically significantly compared to the Ezetimibe 10 mg administration group, and the average LDL-C change rate (%) in Ezetimibe / Rosuvastatin 10/2.5 mg administration group decreased by 2.5 mg. Through clinical trials, the complex has already been announced
