- LOGIN
- MemberShip
- 2025-12-24 13:21:13
- Policy
- The mechanism by SGLT2 inhibitors was first identified
- by Lee, Hye-Kyung May 18, 2020 06:15am
- Research has shown that the 'diabetes treatment agent' SGLT2 inhibitor lowers the risk of cardiovascular disease by inhibiting inflammatory cytokine secretion. Jung-Sun Kim, Professor of cardiology, Yong-ho Lee Professor of endocrinology, and Sang-Guk Lee Professor of laboratory medicine at Severance Hospital and So Ra Kim, Professor of hospital medicine at Yongin Severance Hospital said on the 14th that SGLT2 inhibitors significantly reduced inflammatory cytokine secretion in macrophages. This is the first study to show that SGLT2 inhibitors reduce cytokine secretion in the human body, and was published in the latest issue from Nature Communications, a world-renowned international academic journal. Diabetes is closely related to abnormal metabolic conditions, including inflammation, dyslipidemia, and insulin resistance. Among these, inflammatory cytokines involved in inflammatory reactions are being identified as causes of various cardiovascular disease (CVD) such as myocardial infarction, heart failure, and angina. Inflammatory cytokines are secreted from NLRP3 inflammasomes present in macrophages. SGLT2 inhibitors are known to reduce cardiovascular disease or mortality in diabetic patients by inhibiting reuptake of glucose from the kidneys. The American Heart Association, the ESC, and the EASD recommends that SGLT2 inhibitors be given priority to other medications for diabetics at high risk of cardiovascular disease. However, the mechanism by which SGLT2 inhibitors lower the risk of cardiovascular disease has not been determined. The research team randomly selected type II diabetes patients admitted to Severance Hospital from November 2016 to July 2017, and divided them into groups A and B. Group A (29 patients) assigned to treatment with SGLT2 inhibitors and group B (32 patients) received a sulfone urea drug, a diabetes drug that promotes insulin secretion. As a result of analyzing macrophages isolated from blood after 1 month, group A significantly decreased secretion of inflammatory cytokines than group B. SGLT2 inhibitors inhibited NLRP3 inflammasome activity by 83% more than group B by lowering blood sugar and reducing uric acid and insulin hormone. Particularly, in group A, NLRP3 inflammasome activity and inflammatory cytokine secretion were decreased in the body compared to before administration of the drug, but group B had no such effect. In the group A taking the SGLT2 inhibitor, the blood ketone body (β-hydroxybutyric acid) also increased from 0.06 mM to 0.20 mM. Increased blood ketone bodies inhibited the activity of NLRP3 inflammasomes, resulting in decreased secretion of inflammatory cytokines. Professor Yong-ho Lee said, "While large-scale studies have been reported that SGLT2 inhibitors reduce cardiovascular disease, researchers around the world are very interested because the mechanism by which cardiovascular disease is reduced is not yet clear." Professor Lee said that this is the first study that revealed that SGLT2 inhibitors reduce NLRP3 inflammasome activity and inflammatory cytokine secretion in the human body, and further studies will be conducted in the future.
- Policy
- Patients suffer from quarrels between companies & the HIRA
- by Lee, Jeong-Hwan May 18, 2020 06:15am
- Patients urged Ono Pharma Korea, BMS Korea, and MSD Korea to come up with a reasonable burden-sharing plan that the health authorities could accept. Patients have been urging to expand the health benefits of Opdivo (Nivolumab) and Keytruda (Pembrolizumab), which have various therapeutic indications, such as lung cancer and kidney cancer. It is a request to urgently improve the reality that Opdivo and Keytruda have failed in the HIRA’s Cancer Drug Review Committee due to controversy over the financial burden of health insurance due to high prices. On the 14th, at 10 am, the Korea Alliance of Patients Organization held a press conference in front of Ono Pharma Korea, urging the expansion of health benefit for immune cancer drugs. At 1 pm on the same day, the Korea Alliance of Patients Organization will hold a press conference with the same purpose at the Seoul Women's Plaza. The Korea Alliance of Patients Organization was scheduled to hold an interview in front of Ono Pharma Korea and MSD Korea, the developer of Opdivo and Keytruda respectively. Changes in place were inevitable as meetings and interviews became impossible due to the occurrence of COVID-19 confirmed patients in Seoul Square, where MSD resides. The patient's demand is that the developer & the HIRA should stop negotiating drug prices and prepare a reasonable level of financial sharing that the financial authorities will accept. The domestically approved immune anticancer drugs include Ono Pharma·BMS' Opdivo, MSD's Keytruda, Roche's Tecentriq (Atezolizumab), AstraZeneca's Imfinzi (Durvalumab), and BMS' Yervoy (Ipilimumab). Indications are rapidly expanding from non-small cell lung cancer, Hodgkin's lymphoma, head and neck cancer, kidney cancer, bladder cancer, gastric cancer, esophageal cancer, breast cancer, etc., Looking at the health insurance coverage, Opdivo, Keytruda and Tecentriq were reimbursed as non-small cell lung cancer, Opdivo and Keytruda as melanoma, and Tecentriq as bladder cancer. In order to receive treatment with immunosuppressive drugs for indications other than the indications is reimbursed, it costs from ₩ tens of millions to more than ₩100 million. The Korea Alliance of Patients Organization said to improve this reality. "The quality of life of terminally ill cancer patients living in the era of targeted anti-cancer drugs, followed by targeted anti-cancer drugs, has improved in a different dimension than when the first chemotherapy was administered," the organization said. "It is an urgent reason to increase the supply of immuno-cancer drugs." The organization said, “Pharmaceutical companies seeking to get high drug prices and financial authorities trying to save money on health insurance are not making any concession over the expansion of the benefits of anti-cancer drugs.” "We only accepted two indications for head and neck cancer and eliminated indications for kidney and stomach cancer." The organization said that Keytruda’s company also did not accept the expansion of the primary treatment reimbursement standard for non-small cell lung cancer. The HIRA’s Cancer Drug Review Committee asked pharmaceutical companies to prepare a rational financial sharing plan. The organization criticized the patient for dying of life-sustaining or cure-out opportunities while governments and pharmaceutical companies struggled with the price of drugs, such as a proverb saying when elephants fight, it is the grass that suffers. The Korea Kidneycancer association also issued a statement saying that the HIRA’s Cancer Drug Review Committee would speed up the registration of Opdivo for disqualification due to the financial burden. The organization also said that it was difficult to understand that Opdivo did not get kidney cancer benefits from the HIRA’s Cancer Drug Review Committee. According to the organization, the cost of the immuno-cancer drug is close to ₩6 million to ₩10 million per month, but it is also important for the health and financial benefits of the health insurance company, but the most important thing is patient’s life. The organization said that it is necessary to extend the patient's life by using the resources used in the patient support program that is conducted before the reimbursement to reduce the price.
- Policy
- Xeljanz was rejected for the uninsured benefit
- by Lee, Hye-Kyung May 18, 2020 06:14am
- The application to use 'Xeljanz (Tofacitinib citrate)' from Pfizer Korea, which has been approved for rheumatoid arthritis and ulcerative colitis, was rejected for the uninsured benefit for patients with dermatomyositis or severe alopecia. The HIRA is applying in advance for the uninsured benefit that is not approved by the MFDS in order to prevent the use of drugs that lack medical basis or are concerned about safety. According to the details of the 'disapproval of the uninsured benefit' recently released by the HIRA, 10 new cases of disapproval, including Xeljanz, have been added, resulting in a total of 183 cases of disapproval of the uninsured benefit. First of all, in the case of Xeljanz, a medical institution applied to prescribe 5mg twice a day for 6 months to refractory dermatomyositis patients, but was rejected due to insufficient medical evidence. Another medical institution has requested that Xeljanz be used in patients with severe alopecia areata who have failed to continue treatment with systemic steroids or Cyclosporine for 3 months or cannot continue treatment due to side effects (alopecia over 80% of the entire scalp area). This institution evaluated the area of hair loss every 6 months and compared to the first time, if the area of hair loss decreased by more than 50% (SALT 50), it will be administered continuously, and the drug will be discontinued if hair loss improves with an SALT score of 10 or less. However, due to insufficient evidence, it was rejected. In this case, 'Olumiant (Baricitinib)', a treatment for rheumatoid arthritis in Lilly Korea, has been newly added. A medical institution said that it would administer Olumiant once a day to patients in 2019-nCoV acute respiratory disease, among patients undergoing inpatient treatment, fever, elevated inflammatory values, pneumonia findings and hypoxia in chest radiographs not improving or worsening. However, the HIRA said, "The data presented suggests the theoretical possibilities screened by artificial intelligence, and medical evidence is insufficient to support clinical use." In addition, it is not permitted to use the uninsured benefit because there are warnings that infection patients should not be used, and that the infection rate will be increased.” In addition, 'Botox', Carmine Injection 0.8%, Tuberculin PPD RT , Diabex XR, Luphere Depot, Enbrel, Enbrel Myclic Pen 50mg, Eucept Prefilled Syringe, Eucept autoinjector which have been applied for the uninsured benefit, were also not approved for use due to insufficient medical evidence of the submitted data.
- Policy
- Korea takes two-track approach on vaccine and treatment
- by Kim, Jung-Ju May 15, 2020 06:04am
- To speed up the development of Korean-made COVID-19 vaccine and treatment, the Korean government is swiftly working two most urgent regulatory changes. The revised regulation would stipulate Korean Red Cross, a non-healthcare institute, to collect blood samples integral for convalescent plasma therapy, and grant private companies to access biosafety laboratory. For a better access to needed drugs, the government has set a two-track approach to promote Korean-made medicine development and also to supply multinational pharmaceutical companies’ products. On May 8, the government officials convened a second meeting for the COVID-19 Treatment and Vaccine Development Pan-government Support Committee at the Westin Chosun Seoul to confirm COVID-19 treatment vaccine development status and strategies and to discuss regulatory revision approaches to expedite the R&D process. An image from the first meeting convened on Apr. 24 for the COVID-19 Treatment and Vaccine Development Pan-government Support Committee at the Government Complex Seoul. Besides the co-committee heads Minister of Health and Welfare Park Neung-Hoo and Minister of Science and ICT Choi Kiyoung, other related vice-ministers and Korean treatment and vaccine experts have gathered at the meeting. From Apr. 17, the government has activated the pan-government support system by weekly holding subsector meeting regarding treatment, vaccine, and disease control product and devices, and by biweekly holding meeting for the Pan-government Support Committee and working-level task force. Moreover, the government has paid attention on closely listening to and rapidly resolving complaints made by 21 companies seeking for COVID-19 treatment and vaccine through a corporate service center formed under the pan-government support committee. According to the COVID-19 treatment and vaccine development status in Korea briefed at the meeting, seven of clinical trials are in progress to expand indications on existing drug (drug repurposing). Apparently, an earliest release to the market would be feasible by the end of the year. Also there are three candidate medicines for vaccine, which are in preparation to initiate the clinical studies within this year. They are expected to be manufactured in the latter half of next year. In particular, the pan-government support committee has decided to amend two regulations urgently to expedite the treatment and vaccine development. First, the government is to offer a regulatory support for convalescent plasma therapy development. To accelerate the plasma therapy R&D, an abundant load of convalescent plasma drawn from patients cured from COVID-19 is needed. Currently, however, the blood sample collection is only possible in healthcare institute in Korea, and because Korean Red Cross is not a healthcare institute, it had difficulties in collecting R&D-purpose plasma collection. The Article 33 of the existing Medical Service Act restricts a healthcare provider without an established healthcare institute as stated in the law from practicing a medical service. But, when a leader of the state or regional government body recognizes and requests an exception, as needed for the public interest, the healthcare provider may practice a medical service within a healthcare institute. Accordingly, Ministry of Health and Welfare (MOHW) plans to interpret the statute to stipulate Korean Red Cross to collect plasma for research purposes and also to help healthcare institute lacking plasma collecting devices by renting out apheresis system to streamline plasma collection. To assist the healthcare providers, the government would publish ‘Convalescent Plasma Collection Guideline for COVID-19 Plasma Therapy Development’ and promptly set down plasma collecting standards. Furthermore, the government is to grant private corporate to access biosefaty laboratory to encourage corporate research on treatment and vaccine. A biosafety level 3 (BL3) laboratory is essential to test the effect of COVID-19 treatment and vaccine candidates, but private companies struggle to have its own BL3 lab. So their demand for the government to open the public BL3 lab for corporate use is high at the moment. So far, the government has allowed the use of facility after Korea Research Institute of Bioscience and Biotechnology (KRIBB) individually investigated each case, but the access would be expanded. Korea Centers for Disease Control and Prevention (KCDC) would list BL3 lab operating institutes on its website and link BL3 lab operating institutes with pursuing companies for more active use of public BL3 labs, after reviewing the demand of private (industry, academy, and research) use of the lab. The ‘Support Team for Private Use of Biosafety Laboratory,’ consisting of KCKC biosafety management officers and research department experts, would be newly formed and take charge of the demand and prioritization review and safety management. Meanwhile, the government is also planning to facilitate distribution of overseas pharmaceutical products to enhance patients’ access to treatment. Minister Park Neung-hoo of Health and Welfare stressed at the meeting, “We need a strategic prospective on the treatment and vaccine development support policy,” that “concentrates industrial, academic and research capacity to rapidly seek for Korean-made treatment and vaccine with assured safety and efficacy, and also that stably imports finished product or active ingredient, and essential disease control equipments. Therefore, a two-track approach should be the base of the policy.” Minister Park added, “Related ministries would cooperate together to listen to companies’ issues and resolve the issues in a streamlined manner. As each company faces unique situation, the government support varying from regulatory reform to R&D funding would be customized to meet their needs.” Minister Choi Kiyoung of Science and ICT emphasized “The fundamental key to overcome the COVID-19 outbreak is in successful development of treatment and vaccine,” and stated, “Seeking treatment and vaccine is an integral task to establish a concrete foundation for Korea to leap forward in the post-coronavirus era. The government would continue to endeavor creating reliable economic environment for the people.”
- Policy
- HIRA, promote 'COVID-19' outcome at OECD
- by Lee, Hye-Kyung May 14, 2020 02:21pm
- The meeting of the Working Party on Healthcare Quality and Outcomes (HCQO) of Organisation for Economic Co-operation and Development (OECD) was held on 12 May 2020, chaired by Dr. Sun Min Kim, president of Health Insurance Review and Assessment Service (HIRA) of Korea. OECD HCQO was started in 2001 to develop, collect, and compare a set of indicators that reflect a robust picture of healthcare quality across countries using comparable data. HCQO Working party is made up of representatives of OECD countries and international organizations such as WHO, European Commission, International Hospital Federation and ISQua, and more than 100 experts participated in this meeting. HIRA has represented Republic of Korea for OECD HCQO Working Party since 2007, and President Kim has been actively involved from 2009. President Kim was elected as the chairperson of HCQO Working Party for 2019-2020 as the first women and Asian to hold the chair, and re-elected for 2020-2021. Given the unprecedented challenges from global pandemic, the OECD HCQO meeting was held as virtual meeting and dedicated to the health system readiness and COVID-19 response. The meeting was divided into two sessions; overview of HCQO original work streams and health system readiness and COVID-19 response. In Session 1, Dr. Katherine de Bienassis of OECD Secretariat provided brief overview of agenda documents for feedback and committee actions on ongoing HCQO work on people-centered health data systems, performance of integrated care delivery systems, patient-reported indicators survey, broadening the patient safety measurement agenda, quality indicators for end of life care, and process and updates for the HCQO 2020-2021 data collection. The delegates were invited to comment on the progress made and provide written feedback for further discussion on the next HCQO Working Party Meeting in October. In session 2, participants discussed how health system readiness and emergency preparedness fit into the HCQO’s patient safety and health system performance agenda. Dr. NiekKlazinga of OECD Secretariat provided COVID-19 and the work of the HCQO Working Party, noting the importance of health system preparedness and data infrastructure as a component of the patient safety agenda. Emergency management is comprised of four stages and domains - preparedness, response, mitigation, and transition towards recovery. At this stage, a number of countries beyond the peak of pandemic, health systems should be ready to address challenges in transition towards recovery. COVID-19 poses dual challenges for health care quality and outcomes to ensure high quality, safe and coordinated care both for COVID-19 and non-COVID patients. The transition phase may last more than a year and health systems have to balance the increased demands of acute care related COVID-19 with on-going needs of healthcare system to maintain and provide essential services for all non-COVID patients including but not limited to vaccination, chronic care and cancer care. Next with the Secretariat, selected three countries shared their experiences in response to the COVID-19 pandemic. Dr. Kim representing Republic of Korea provided country kick-off presentation on national response to COVID-19 utilizing real-time healthcare resource and claims data to detect high-risk group, prevent spread in community, collect patient information centrally, and monitor the status of resources including negative pressure isolation room, mask and drug supply. Representative of Australian Commission on Safety and Quality in Healthcare shared the national containment and mitigation strategies and measurement of health system approach. Finnish representative provided national data registries on hospital discharge and intensive care and pilot patient data repository to highlight the data collection and utilization. The delegates carried out a poll on their national experiences in data infrastructure, patient safety and integrated care to tackle the pandemic. As a result of polling, it was significantly noted that all participating countries faced safety challenges regarding COVID-19 in long-term care and ensuring the safety of healthcare workforce, technologies and supplies which were rooted from massive outbreak in long-term care setting and shortage in supplies. The participants provided a comprehensive opinion on the capacity of health data infrastructure including timely data collection, person-based data generation, new or improved data linkage to deal with COVID-19, as well as privacy concerns about personal data use. Lastly, the polling results addressed the importance of integrated care approach to track patient outcomes outside of the hospital, monitor the flow of COVID-19 and non-COVID patients, and emphasize the role of primary care during the mitigation phase of the crisis. The OECD HCQO will continuously work together to measure health system resilience and readiness to strengthen collaboration and generate potential candidates for international benchmarking and further OECD analysis. In this regard, Dr. Kim, as a chairperson of OECD HCQO Working Party and a president of HIRA, said that she would share institutional experiences and lessons of HIRA with global communities and support for member countries’ policy to tackle the pandemic and global health crisis.
- Policy
- Issues on e-cigarette·NDMA were raised again
- by Choi sun May 14, 2020 06:25am
- Issues related to medicines that were quiet due to the COVID-19 outbreak were raised again. There are big issues waiting to be investigated, from sampling investigations of Metformin to conducting work on overseas manufacturing plants and publishing results of risk studies of electronic cigarettes. According to the MFDS on the 13th, it recently announced that it has been tested for incorporation of NDMA (N-nitrosodimethylamine), a carcinogen related to Metformin, and will release it soon. #Last year, the MFDS tested the NDMA incorporation by collecting the entire manufacturing lot numbers and the four same ingredients of Nizatidine, which have similar chemical structures, as well as Ranitidine. The MFDS disclosed the test results of 395 items in two weeks after September 14 when the possibility of NDMA impurities of Ranitidine. Metformin, on the other hand, has begun investigations since December last year, but the results have not been released. An official from the Ministry of Food and Drug Administration said, "Metformin may have a different NDMA content depending on the production process’ lot numbers." and he added that the same drug substance also secured a large number of samples for each process and investigated the contents of about 900 samples. " He explained that it took time for a large number of samples and more time to investigate finished products as well as to correct the content variation. He said that the administrative work was paralyzed because of the COVID-19 outbreak, saying that the prosecution had already been completed and that the results would be published soon in the stage of collecting and analyzing the results. The MFDS is planning to calculate the daily allowable dose and the likelihood of carcinogenesis according to the daily dose, based on the results of this survey of Metformin’s NDMA. In March, the MFDS announced that it would convert the current survey of overseas factories into document review due to the global spread of COVID-19. An official from the MFDS said the transition was a temporary measure to ensure that there was no disruption to the domestic medical product approval schedule and supply and demand, and that due diligence in overseas factories, including pharmaceutical production plants in Fukushima, would be restarted after confirming the status of COVID-19. Meanwhile, safety measures for Belviq remain unchanged. In January, the FDA warned of the risk that Belviq would develop cancer, and the MFDS decided to discontinue sales of Belviq in February. The FDA analysis showed that more patients in the Belviq group compared to placebo were diagnosed with cancer in the clinical trials of approximately 12,000 patients for 5 years, but there was a disagreement over statistical significance. This is because primary cancer was diagnosed in 462 (7.7%) out of 5,995 patients receiving Velviq and 423 (7.1%) out of 5,992 patients receiving placebo. Some medical practitioners have judged that the figure is difficult to have statistical significance within the margin of error. Officials from the MFDS said that the suspension and recovery measures were preemptively responded to the unknown cancer controversy rather than the basis for actual judgment. he added that they had obtained and analyzed raw data because it was not possible to verify statistical differences with cancer rates of only 7.7% versus 7.1%. He added that, after reviewing the FDA data, there was no change in the decision and that will remain until further new action, such as the FDA, is taken. On the other hand, the results of the research on the dangers of liquid cigarettes next month are also coming out. The research results on the hazards jointly conducted by seven related ministries, such as the MOHW, have been attracting attention because it can serve as a basis for kicking out liquid electronic cigarettes. The MFDS has been conducting liquid electronic cigarette inhalation and human toxicity studies since June last year by the request of the MOHW. An official from the Ministry of Food and Drug Safety explained that in December last year, we disclosed the results of the investigation of the composition of liquid e-cigarettes. and he also added that the current research is related to the correlation between liquid e-cigarettes and human health. "It took time because the capacity and product container specifications were different between the items and the test method was not established, and the content will be released as early as next month." he said.
- Policy
- Exports of the health industry in April rose 20%
- by Lee, Tak-Sun May 14, 2020 06:24am
- As the export of diagnostic reagents and disinfectants increased in the aftermath of COVID-19, the export amount of the health industry increased by more than 20% from the same period last year. The KHIDI (Korea Health Industry Development institute (Director Kwon Deok-cheol) announced monthly health industry export performance. In April, exports of the health industry totaled $ 1.7 billion, an increase of 20.2% compared to the same month last year, followed by $ 640 million in medicines (+ 23.4%), $ 570 million in cosmetics (-0.1%), and $ 490 million in medical devices (+ 50.8%). K- quarantine items such as domestic biopharmaceuticals and diagnostic kits have led the growth of exports in the health industry. In particular, export growth of diagnostic reagents and disinfectants has been high due to the surge in overseas demand following the global expansion of COVID-19. By country, as exports of medical devices (diagnostic kits) increased significantly, Brazil (14th to 7th) and India (13th to 9th) entered the top 10 countries for export. and exports to the United States (2nd place), Japan (3rd place), and Germany (4th place) are expanding. By item, biopharmaceuticals accounted for 48.7% of the total exports of pharmaceutical products, and K-prevention items such as diagnostic reagents ($ 146 million) and disinfectants ($ 44 million). The cumulative export amount of the health industry (Jan 2020~April 2020) was $ 6 billion, an increase of 21.9% from the same period of the previous year, and by industry, cosmetics ($ 2.3 billion, +11.8%), pharmaceuticals ($ 2.3 billion, +38.3%) and medical devices ($ 1.4 billion, +16.8%) were followed. An official from the KHIDI said that the domestic health industry exports remained strong despite COVID-19 continues to exist worldwide, and are recognized as a K-defense model and expect that related products will continue to lead the health industry exports in the future. The KHIDI will analyze the monthly export trend of the health industry starting in May of this year and provide it through the website of the KHIDI and the Health Industry Statistics Portal at the beginning of each month.
- Policy
- KAPO demands MFDS to swiftly approve Lutathera
- by Lee, Jeong-Hwan May 13, 2020 05:54am
- A patient group once again urged for a prompt approval review on neuroendocrine tumor treatment Lutathera (lutetium Lu 177 dotatate). The group demanded the Korean government to take action fast for the patients with neuroendocrine tumor in agony with inevitable overseas treatment and burdensome pharmaceutical expense amid COVID-19 pandemic. On May 11, Korea Alliance of Patients Organization (KAPO) held a press conference in front of the Ministry of Food and Drug Safety (MFDS) headquarter office in Osong and insisted the government to urgently take necessary action. KAPO officials explained currently about 100 patients with neuroendocrine tumor in Korea have been traveling to Malaysia to get access to radiopharmaceutical injections containing similar substance as Lutathera from 2018. The organization claimed patients in France and the U.S., where Lutathera is accessible, pay approximately 26 million won per shot, and at least 140 million won for a single cycle with four injections. KAPO also stated MFDS has been neglecting on their duty as the ministry has not expedited the approval procedure on Lutathera, when the drug has been designated as an orphan drug to meet urgent medical needs. The patient organization explained Korea Orphan and Essential Drug Center (KOEDC), specially distributing the drug for emergency purpose for now, has exceptionally requested for insurance reimbursement to Health Insurance Review and Assessment Service (HIRA). Apparently, however, HIRA has been sluggish with the listing review due to the prospective financial burden and concern of multinational pharmaceutical companies abusing the system. Ultimately, they argued, it is up to MFDS to officially approve the marketing of Lutathera in Korea and HIRA to officially review the reimbursement to improve the state the patients are in. KAPO official stressed, “MFDS should approve Lutathera and stop neglecting patients in life-threatening situations and letting them suffer in series of overseas treatment and financial struggle,” and “Novartis should also closely cooperate with the government approval procedure.”
- Policy
- Whanin, begins development of first generic for Fycompa
- by Lee, Tak-Sun May 13, 2020 05:54am
- Antiepileptic drug Fycompa by EisaiWhanin, for the first time as a domestic pharmaceutical company, started developing generics for antiepileptic drug Fycompa by Eisai. If the generic development proceeds smoothly, it is expected that it will be aprproved next year as soon as possible. The MFDS approved the bioequivalence test plan for 'Peranel 6mg' submitted by Whanin on the 8th. Peranel is an imaginary item that has not yet been approved, and is the same ingredient as Fycompa. The bioequivalence test is conducted for the purpose of securing equivalence by comparing the absorption rates of Peranel and Fycompa in 56 healthy adults. The test was designed to run through May next year. Anyway, application for permission is possible only in July of next year. This is because Fycompa's PMS will expire on July 9th next year. Generics can be applied for approval only after the PMS period of the original has ended. Since Fycompa's material patent is due to expire on October 13, 2023, it will take three years to get to the market. Whanin filed a decision to confirm the passive scope of the right to evade the crystalline form patent scheduled to expire on October 14, 2026 in February. Since Myungin Pharmaceutical also requested the relevant judgement, it is highly likely to develop generics along with Whanin. Fycompa is a selective non-competitive a new mechanism of epilepsy treatment that antagonizes the AMPA (α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid) receptor, and has been designated as a new drug for six years of reexamination (PMS) by the MFDS. In 2017, it was approved by the US FDA as a monotherapy for patients with epilepsy (epileptic) partial seizures over 12 years of age with or without secondary systemic seizures. Based on UBIST, last year's domestic prescription amount was ₩3.4 billion. It has the advantage of being convenient for epilepsy patients to use, especially once a day.
- Policy
- Chong Kun Dang to enhance Eliquis generic quality
- by Lee, Tak-Sun May 12, 2020 06:27am
- Chong Kun Dang is to enhance quality of Liquisia, a generic version of coagulant medicine Eliquis. Currently leading the Eliquis generic market, Liquisia is aiming for sales expansion through the substance quality improvement. On Apr. 29, Ministry of Food and Drug Safety (MFDS) approved of bioequivalence test plan for Liquisia (apixaban) 5 mg tablet (apixaban). The test would confirm Liquisia’s pharmaceutical absorption rate in healthy adult equal to Eliquis 5 mg tablet. However, Liquisia 5 mg has already passed a bioequivalence test against Eliquis before. The apixaban generic is not even manufactured by a cosigned company. It was approved as a directly manufactured item in March of 2018. The Korean pharmaceutical company has reportedly initiated the latest bioequivalence test project to improve the quality of pharmaceutical substance and manufacturing procedure. The details of the improvement to be made from the existing version have not been revealed, yet. Recently, Chong Kun Dang’s Liquisia sales has skyrocketed. According to the pharmaceutical industry research firm UBIST, the generic’s outpatient prescription volume has reached 395 million won in last first quarter, placing itself on the top among the apixaban generics. Compared to fourth quarter last year, the prescription volume has surged by approximately 80 percent. Although the volume was insignificant against Eliquis generating 12.28 billion won in the same quarter, the industry experts view Chong Kun Dang’s new strategy to expand its new oral anticoagulant (NOAC) generic sales to clinics would work in the end. The company is most likely to strengthen the commercial value and market competitiveness of the generic by enhancing the substance quality. Facing fierce marketing strategies from generics, the original Eliquis maker Bristol-Myers Squibb (BMS) would have to make tighter actions. The multinational pharmaceutical company’s damage would snowball once the currently suspended pricing reduction is executed or the company completely loses in the ongoing patent trial. Fortunately, BMS has successfully protected the initial pricing as Administrative Court, High Court and the Supreme Court accepted the company’s application for an injunction. However, the pricing would be lowered by 30 percent, if the litigation on pricing reduction processed by the High Court is ruled against the company Also, an outcome of the ongoing patent nullification litigation on the original’s pharmaceutical substance could drastically change the market scene. If the Court makes the decision to nullify the patent, already-approved 20 to 30 generics would be launched shortly, dodging the patent infringement issue. The Korean industry would keep a close eye on the apixaban market as it has opened the first door to the NOAC market for Korean companies.
