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- 2025-12-23 20:01:33
- Policy
- MFDS to support domestic vaccine for COVID-19
- by Lee, Tak-Sun Apr 14, 2021 06:06am
- The MFDS has announced that it will establish a new indicator that eases the phase 3 clinical criteria for the existing COVID-19. Through this, the plan is to support the rapid commercialization of domestically developed vaccines. Director Kang-rip Kim made such a statement at a briefing at the special quarantine inspection meeting in response to COVID-19 on the 12th. Director Kim said, "We will promote the rapid establishment of immune surrogate indicators that enable clinical trials at low cost and with a smaller number of subjects compared to the existing phase 3 clinical trials," and "guide for vaccine development using immune surrogate indicators. We will cooperate with international organizations such as WHO as well as presenting the line in detail and securing basic data by analyzing the immunogenicity of the vaccinated person." In addition, he added, "We will also promote technical support for production and quality control, such as establishing production technology and test methods for each platform of vaccine for most domestic vaccine developers without mass production experience." Phase 3 clinical trials of COVID-19 vaccine are administered together with placebo to compare the number of confirmed cases, which requires tens of thousands of subjects, which is expensive and time consuming, and the speed varies depending on the environment of COVID-19 occurrence. Accordingly, the industry is demanding the establishment of an immune proxy to replace this, which is being reviewed positively by the MFDS. The MFDS is also planning to expand the scope of clinical trials for Regkirona, a domestic antibody treatment. "The domestic antibody therapy Regkirona is limited to the use of the elderly, cardiovascular, respiratory, diabetes, and hypertensive patients due to the lack of clinical evidence due to short-term development." "We will support the expansion to patients with reduced immunity and obesity such as heart disease and cancer." He emphasized, "If we approve treatment purposes for emergency patients, we will support timely treatment of corona patients, such as shortening administrative procedures." Lastly, the MFDS promised to support the rapid introduction of self-test kits. Therefore, it is an explanation that we will cooperate with related ministries to shorten the development period, which normally takes 8 months, to less than two months.
- Policy
- Hanmi’s Rosuzet with annual sales of ₩99.1 billion
- by Lee, Tak-Sun Apr 13, 2021 05:46am
- Rosuzet (Hanmi, Rosuvastatin-Ezetimibe), a blockbuster drug with annual prescriptions of ₩99.1 billion, expects to add a new dose. Rosuzet is currently licensed for three doses, and the new dose is known to contain unlicensed doses in Korea. According to industry sources on the 12th, Hanmi recently applied for a new dose of Rosuzet to the MFDS. Rosuzet is a combination drug that combines Rosuvastatin and Ezetimibe, an ingredient for treating hyperlipidemia, containing Ezetimibe 10 mg and three different doses of Rosuvastatin. Specifically, there are 3 items including Ezetimibe-Rosuvastatin 10/10mg, 10/20mg, and 10/5mg. Currently, Rosuvastatin 5mg, 10mg, and 20mg are approved in Korea. However, it is known that the product applied for approval this time contains 2.5mg of Rosuvastatin. Overseas, there are also 2.5mg and 40mg in addition to the currently approved 10mg, 20mg and 5mg in Korea. In particular, Ministry of Health, Labor and Welfare of Japan recommends an initial dose of 2.5mg considering the size of Asians, which are smaller than Westerners. The effect is improved as Rosuvastatin increases, but it is said that side effects also increase. Accordingly, customized prescriptions are also being made in the medical field. Rosuzet's earnings are expected to improve if the number of products by dose increases, taking this into account. In particular, Rosuvastatin 2.5mg and 40mg do not exist in Korea, so the choice of prescription is expected to improve. Rosuzet was a blockbuster drug with sales of ₩99.1 billion (based on UBIST) in outpatient prescriptions last year. However, it is difficult for Rosuzet to maintain its market share, as products such as generics for Atozet have recently been poured into the Statin-Ezetimibe combination market. Therefore, it is noteworthy whether new dose products will lead to growth.
- Policy
- Sanofi withdraws 'EVE QUICK' from domestic market
- by Lee, Tak-Sun Apr 13, 2021 05:46am
- Imported pain relievers that entered the Korean market late are not faring well in Korea's market. This is because brand products like Tylenol, Geborin, and EZN have already settled in the market, and the fierce competition ongoing between multiple companies has left no room for late entrants. As a result, Sanofi has withdrawn its license for ‘EVE Quick tablet’ on the 8th. The 'EVE QUICK tablet' was first introduced to Korea in 2011 by Boehringer Ingelheim. Based on a non-steroidal anti-inflammatory pain killer, ibuprofen, its formula contains magnesium oxide and allyl isopropyl acetyl urea. Like its name, the product was focused on treating pain experienced by women, such as menstrual pain. The drug, which was produced by Boehringer Ingelheim Japan, was often introduced as a must-buy item for travelers to Japan. Sanofi has been selling EVE QUICK since 2017 after acquiring Boehringer Ingelheim's OTC division. In the early days of its release, full-scale efforts were made for the sale of EVE QUICK, including a marketing partnership with Yuhan Corporation. However, its sales revenue did not live up to the company's expectations. In addition, competition became more intense with various pain relievers for women entering the market in the 2010s. No results were found on the performance of EVE QUICK for the past three years on IQVIA, an institution that researches the drug market. In the pain reliever market for women, KyongDong Pharm's 'GNAL-N,' Janssen Korea's 'Women's Tylenol,' and Samjin Pharm’s 'Geworin soft capsule' are waging fierce competition. In 2019, Sanofi also decided to not renew its license for its ‘EVE-A tablet,' leaving it to expire. With the withdrawal of EVE QUICK, Sanofi will have completely withdrawn from the domestic pain reliever market. Other late entrants are also not living up to their company’s expectations. GSK Consumer Healthcare’s ‘Advil' is one example. Although Advil is one of the most commonly sold pain relievers with Tylenol, since its launch in 2013, it has failed to produce significant results in Korea. Based on IQVIA data, Advil’s sales only amounted to 1.6 billion won in 2020. In 2018, Oxy Reckitt Benckiser also withdrew the marketing license for its 3 types of Nurofen pain relievers.
- Policy
- New drug Leclaza, only drug price negotiations remain
- by Lee, Hye-Kyung Apr 13, 2021 05:45am
- 'Leclaza (Lazertinib)', a non-small cell lung cancer treatment by Yuhan Corporation, the 31st new drug developed in Korea, has passed the first step of reimbursement. After receiving approval from the Ministry of Food and Drug Safety on January 18, the HIRA's Pharmaceutical Benefits Advisory Committee recognized the appropriateness of reimbursement within 81 days. When the HIRA notifies the Minister of Health and Welfare of the results of the review, Leclaza will proceed with drug price negotiations for about 60 days with the NHIS at the order of the Minister of Health and Welfare. When the drug price negotiations with the NHIS are over, the final notification is made through the resolution of the Health Insurance Policy Committee of the Ministry of Welfare. According to the data released by the HIRA in 2017, it takes about 1,030 days for anticancer drugs, 475 days for rare disease drugs, and 550 days for general drugs from approval to notification from the MFDS. In comparison, the anticancer drug Leclaza is expected to shorten the salary registration period by about 30 months. 'Leclaza's high-speed registration process was accomplished because it utilized the permission-insurance drug price evaluation linkage system. The linkage of permit-reimbursement evaluation has been implemented by the MOHW since September 2014, and it is a system that allows new drugs that have been reviewed for safety and efficacy to request permission from the MFDS and at the same time request an evaluation of benefits from the HIRA. From 2016, it is possible to link approval-benefit evaluation to orphan drugs as well as new drugs, so that the pharmaceutical company can apply for drug price evaluation before formal approval if desired. On the other hand, Leclaza is a drug used for the treatment of patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer who have previously been treated with EGFR-TKI. Based on the results of a phase 2 clinical trial (therapeutic exploration clinical trial) conducted in Korea last January, Yuhan applied for permission to the MFDS under the condition of conducting a phase 3 clinical trial (therapeutic confirmation clinical trial) after marketing. .The MFDS also determined that Leclaza is a target anticancer drug that inhibits the proliferation and growth of lung cancer cells by interfering with the signal transmission involved in lung cancer cell growth, and has the advantage of being less toxic to normal cells .The HIRA initiated a reimbursement review following the approval of the safety and effectiveness of the MFDS .On February 24, the agenda was presented and passed by the Cancer Drugs Benefit Appraisal Committee and the Pharmaceutical Benefits Advisory Committee on April 8 .
- Policy
- 1st Gen. Economic Evaluation Expert Retires from Teaching
- by Lee, Hye-Kyung Apr 12, 2021 05:55am
- Chung-Ang University College of Pharmacy professor Dong-Churl Suh (65), an economics and policy expert in the domestic and foreign pharmaceutical industry, will be retiring in August this year. After graduating from Chung-Ang University College of Pharmacy in 1979, Suh went to the U.S. and obtained a Master of Business Administration from the State University of New York at Buffalo and a Ph.D. in Health Economics from the University of Minnesota. Since 1994, he had lectured and researched the field of pharmaceutical economy and policy serving as a professor and director of the Rutgers University Ernest Mario School of Pharmacy. Prior to teaching at the Rutgers University, Suh was involved in the innovative healthcare policy design team proposed by former U.S. President Bill Clinton during his election process to propose various research and policies related to drug pricing. Later, as a tenured professor at Rutgers University, Suh taught and researched in the fields of pharmaceutical economics, policy, and clinical trial design while serving as director of the Center for International Pharmaceutical Economics and Policy. Suh also participated as an advisor for the New Jersey government for making health care policy decisions. Suh said, "New Jersey, the state where Rutgers University is located, operates many US government and healthcare-related projects, and is a mecca well known by the global pharmaceutical industry. As research director, I worked with various major pharmaceutical companies that had headquarters near the university such as Johnson & Johnson, MSD, Sanofi, Novartis, BMS, and Pfizer. While studying at the University of York and the University of Sheffield in the UK for two years, I participated in the decision-making process of the National Institute for Health and Care Excellence (NICE) while conducting joint research on economic evaluation." These various activities had become the ground for his fame in the US as an economic evaluation and policy expert in the field of pharmaceuticals. Suh was also the one to suggest that Korea needs a new drug pricing system including the introduction of the economic evaluation system. In the early 1990s, during the days of the Federation of Korean Medical Insurance Societies before the Health Insurance Review and Assessment Service, Suh introduced the economic evaluation to address the need for an objective indicator of a drug's price. After becoming a tenured professor at Rutgers University, a position that is extremely difficult even for U.S. citizens to achieve, why did Suh return to teach at a college of pharmacy in Korea, where professors are required to retire at the age of 65? The biggest reason for Suh's return to Korea after 25 years was his parents. When his mother passed away from cancer, Suh chose to return to Korea to take care of his lone father. “When returning to Korea, I received numerous offers from various top universities in Korea. However, I chose my alma mater, Chung-Ang University. While serving as the Dean, I carried out various measures to prepare the college for the 6-year Pharmacy Program and for the establishment of a specialized graduate school for pharmacy. In addition, I invited international economic evaluation and regulatory science experts from the US FDA, Europe EMA, as well as those in the field of Biologics for multiple international conferences and training courses.” During his tenure at Rutgers University, he, along with the dean, created a 6-year curriculum for the College of Pharmacy. Among the roughly 130 pharmacy colleges in the U.S., only about 10 including Rutgers University implement the 6-year program that is being currently being pursued in Korea. “While serving as a professor at the College of Pharmacy of Chung-Ang University, I was able to inform people about the current domestic and foreign medical insurance and drug pricing system, the reality of the international pharmaceutical industry, and the U.S. drug price system. At the college system level, my experience in running a 6-year pharmacy program at Rutgers was immensely helpful as Korea's pharmacy education tends to follow the education method used in the U.S.." Suh explained. While industry-related knowledge and skills are essential for entering the pharmaceutical industry or practicing pharmacy after graduation, Suh believes that the 6-year program should focus on strengthening the student's communication and writing skills as those are the most necessary skills for continued self-development. He believes that he did his role in the development of the pharmaceutical industry and pharmacy education at Chung-Ang University during the last 9 years. Recently, he was elected by members to serve as a director of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) for 3 years, an organization that has 20,000 pharmaceutical economy expert members around the world. Along with foreign economic policy experts, as a director, Suh said he hopes to be able to contribute to the development of Korea’s economic evaluation system and system development to improve patient access to new drugs. On his plans after retirement in August, Suh said, "Even after retirement, I plan to find a place where I can continue my contributions to the field of pharmaceutical economy and policy using my various research and policy proposal experiences."
- Policy
- Approval of Moderna's COVID-19 vaccine is imminent
- by Lee, Tak-Sun Apr 09, 2021 05:55am
- Moderna is applying for approval of COVID-19 vaccine from the MFDS sooner or later. It is reported that GC Pharma, in charge of the license and distribution of the vaccine, will have the necessary data for the license and will submit an application for approval next week as soon as possible. On the 8th, a government official said, "GC Pharma has the permit data and is almost ready to apply." "As soon as possible, applications for permits will be filed next week." Moderna's COVID-19 vaccine signed a contract with the government and Moderna in January and decided to introduce 20 million people in the first half. At the end of February, GC Pharma was selected as a license and distribution company through bidding. It is known that GC Pharma has been preparing for a permit application in consultation with Moderna. The introduction of a new vaccine is urgently needed as the supply and demand of COVID-19 vaccine is becoming difficult worldwide. The government aims to inoculate 10 million Koreans in the first half. However, the supply and demand situation of officially licensed vaccines is not good. AstraZeneca vaccine is produced by SK Bioscience in Korea, but the supply of 3.5 million individual contracts will begin at the end of May. Accordingly, the government is in a position that it may review measures to restrict exports depending on the situation. Moreover, AstraZeneca vaccine has recently been controversial over the restriction of use due to the side effects of blood clots. The second approved Pfizer vaccine will come in 3 million people in the second quarter. However, this is only a fraction of the total contract volume of 13 million people. Janssen vaccine, which was licensed on the 7th, signed a purchase contract with the government for 6 million people, but the specific supply timing is unknown. In order for the vaccine to be supplied smoothly, the approval must be carried out quickly. In the case of Moderna vaccines, it will not be too late to proceed with a permit review in order to be able to import in the second quarter. However, in the case of Moderna vaccine, it is expected to proceed immediately without prior review because it has received urgent approval and verification in the US and EU, and clinical data has been accumulated. Then, it is analyzed that approval is possible even in May after a review period of about 40 days. If it is imported immediately upon approval, it will be helpful for vaccination. Moderna vaccine, like Pfizer's vaccine, is an mRNA-based vaccine, and it was found to be 95% effective when vaccinated twice in a phase 3 clinical trial. If supply is available without disruption, it will be of great help to the government's goal of forming group immunity by November.
- Policy
- Review underway for nation's first DPP-4+SGLT-2 inhibitor
- by Lee, Tak-Sun Apr 08, 2021 05:55am
- Domestic companies are one step closer to commercializing DPP-4 inhibitor and SGLT-2 inhibitor combination therapies in Korea. Until now, there were only imported DPP-4+SGLT-2 inhibitor combination therapies available, but Korean pharmaceutical companies have now started to target the market with new developments. According to industry sources on the 7th, Dongkoo Bio&Pharma recently submitted an application to the Ministry of Food and Drug Safety for the approval of its PP-4 inhibitor with SLGT-2 inhibitor combination "Citaflojin Tab.." The submission is also stated in the company’s business report that was recently uploaded on the electronic disclosure system. The business report indicates that the company will apply for the marketing approval of its diabetes combination candidate ‘'DKB19002” in March. The industry predicted DKB19002 to be a new combination drug for diabetes that combines a DPP-4 inhibitor and an SGLT-2 inhibitor. The two inhibitors are current leaders in the diabetes treatment market. DPP-4 inhibitors block the breakdown of GLP-1 to increase levels of active GLP-1. Key products include Januvia, Trajenta, and Zemiglo. SLGT-2 inhibitors block glucose reabsorption, which leads to urinary glucose excretion and lowers blood glucose levels. Key products include Suglat and Jardiance. With the two types of drugs being most often prescribed for the treatment of diabetes, technology to combine the two inhibitors have also been actively studied in Korea. For example, LG Chem has been conducting a clinical trial for the commercialization of its combination therapy that combines the DPP-4 inhibitor gemigliptin with the SGLT-2 inhibitor dapagliflozin, and Aju Pharm has also been conducting a trial on its linagliptin and dapagliflozin combination. The product Dongkoo Bio&Pharma submitted its application for is also predicted to be a DPP-4 inhibitor and SGLT-2 inhibitor combination therapy. Currently, all combination therapies approved in Korea are imported items such as AstraZeneca's Qtern (dapagliflozin-saxagliptin) and MDS’s Steglujan (ertugliflozin-sitagliptin). However, with the price yet to be listed for the drugs, the combination therapies are not being actively prescribed in Korea. Therefore, chances of success are deemed to be high if domestic companies succeed in preoccupying the market through rapid development. All eyes are on whether the DPP-4 inhibitor and SGLT-2 inhibitor combination will sweep the diabetes treatment market.
- Policy
- Novo applies for approval of the first oral GLP-1 treatment
- by Lee, Tak-Sun Apr 08, 2021 05:55am
- An oral tablet formulation of the GLP-1 receptor agonist diabetes treatment that was previously only available as an injection is preparing to launch in Korea. The drug is Novo Nordisk’s ‘Rybelsus (semaglutide).' Novo Nordisk has recently applied for the approval of its Rybelsus tablet to the Korean Ministry of Food and Drug Safety (MFDS). With Lilly’s GLP-1 RA Trulicity (dulaglutide) gaining popularity in the diabetes treatment market, the emergence of a tablet formulation with improved convenience may likely trigger market restructuring. On the 7th, industry sources have said that Novo Nordisk had recently submitted an application for the market approval of its Rybelsus tablet to MFDS. As the first GLP-1 receptor agonist to be ever approved, Rybelsus was approved by the FDA on September 20th, 2019. Semaglutide is the sucessor ingredient of Novo Nordisk’s Victozas·Saxenda (liraglutide). In Korea, Victoza is sold as a diabetes treatment and Saxenda as an obesity treatment. Since its launch, Saxenda immediately swept the domestic obesity treatment market, earning 36.8 billion won in sales according to IQVIA in Korea last year. The injection formulation of semaglutide is sold under the brand name Ozempic, and the oral formulation is sold under the name Rybelsus. Rybelsus is receiving attention as GLP-1 receptor agonists are gaining popularity in the diabetes treatment market. GLP-1 RAs are drugs made using the GLP-1 hormone which is involved with the body’s blood glucose control. GLP-1 increases insulin secretion after meals to lower the glucose levels, and when it falls below a certain level, reduces insulin secretion. According to IQVIA, the once-weekly injection Trulicity had sold 41.8 billion won last year, which was an 11.4% increase from the previous year. A stream of studies showing that GLP-1 RAs are more effective than the more commonly used DPP-4 or SGLT-2 inhibitors in reducing HbA1c, body weight, or blood glucose level have added to the increasing popularity of GLP-1 RAs. However, due to its injection-only formulation, patients had preferred to use drugs of other classes that were available in an oral form. Therefore, the introduction of Rybelsus, the first GLP-1 RA to be provided as an oral tablet, may have the potential to be a game-changer that reshapes the diabetes treatment market that is being led by DPP-4 and SGLT-2 inhibitors.
- Policy
- The NHIS sequentially began managing the entire drug cycle
- by Lee, Hye-Kyung Apr 08, 2021 05:54am
- The NHIS prepares management measures such as treatment effect and cost effectiveness after registration. The NHIS sequentially began managing the entire drug cycle. The NHIS began recruiting external researchers to prepare post-evaluation plans based on actual clinical data after listing drugs exempted from PE Study. This research service is part of the preparation of a full-cycle management plan for drugs that the NHIS decided to pursue in earnest from this year after establishing a drug price management office. The NHIS aims to reinforce the bargaining power for the benefit of excellent therapeutic and economical drugs through full-cycle management such as item permission, the registration, distribution and supply, and follow-up management, and to elaborate contract management so that supply and quality problems can be prevented. The follow-up management of drugs exempted from this PE study corresponds to the registration stage during the entire cycle. The exemption from the PE study is applied to drugs such as a small number of target patients, although it is necessary to apply benefits as a treatment to patients when a new drug such as a rare disease treatment or an anticancer drug is listed. However, as most of these drugs are priced at high prices, it has been said that treatment effects and cost-effectiveness post evaluation after registration are necessary due to the financial burden of health insurance due to continued use. Accordingly, the NHIS plans to prepare a rational system improvement plan in connection with the post-evaluation of exemption from PE study, and a plan for evaluating treatment effectiveness and cost effectiveness using actual clinical data (RWD) through this study. Specifically, in the case of using RWD ▲ Collection of post-evaluation data sources such as request data and medical record data for medical institutions, re-examination by the MFDS, and domestic and overseas clinical trial data after registration ▲ Scientific and systematic clinical effect verification using pharmacodynamic research design and analysis suitable for drug characteristics Through long-term cost-effectiveness estimates such as indicators and model construction, financial impact, social issues, and available data sources are considered to lead to the selection of pilot analysis drugs. The NHIS revealed the necessity of this study, saying, "Through this study, it is necessary to evaluate the treatment effect and cost-effectiveness of drugs exempted from the PE study, and to prepare a follow-up management plan based on this."
- Policy
- 1.25 million doses of Pfizer vaccine were released
- by Lee, Tak-Sun Apr 07, 2021 06:01am
- It was found that 1.25 million doses of Pfizer vaccine, which had been individually contracted so far, received lot release from the MFDS. Following 1 million doses arriving in March, an additional 250,000 doses received lot release from the government in April, and vaccinations started to the general public. According to the MFDS on the 5th, Pfizer Korea's COVID-19 vaccine “Comirnaty” received lot release of 50.1 million doses on March 28, followed by 50.1 million doses on April 1st and 250,000 doses on April 5th. COVID-19 vaccine is distributed in the market after a national quality check. This quality check is the national lot release system of the MFDS. However, only officially approved items receive lot release, and special import items are not subject to lot release. Currently, the officially approved COVID-19 vaccines were made by AstraZeneca and Pfizer. The Pfizer vaccine supplied by Covax are specially imported items. Pfizer's vaccine, which was released from March 28 to April 5, received the first lot release this time. The total number of COVID-19 vaccines that have been released by the national lot is for 1,412,000 people. It contains 1.574 million doses of Astrazeneca COVID-19 vaccine on February 17. As of 24 o'clock on the 4th, the number of people who received COVID-19 vaccine is 962,730. So far, stocks of inoculations remain. However, experts expressed the opinion that the vaccine needs to be increased by securing a large amount of introduction as the supply and demand of vaccines around the world is insufficient.
