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- 2026-04-11 03:01:28
- Company
- PO SMA tx Indication of Evrysdi expands
- by Eo, Yun-Ho Dec 21, 2022 06:05am
- Evrysdi, a PO SMA treatment, can be used for infants under 2 months in Korea. According to related industries, Evrysdi recently obtained approval from the Ministry of Food and Drug Safety to expand the indication. Accordingly, Evrysdi can be administered to newborns before symptoms appear in Korea. The expansion of neonatal indications was based on the results of phase 2 clinical RAINBOWFISH. In the study, the efficacy, safety, pharmacokinetics, and pharmacokinetics of Evrysdi were evaluated for asymptomatic SMA patients who were genetically diagnosed up to 6 weeks of age regardless of the number of SMN2 genes. The primary target point was set as the proportion of patients who could sit without assistance or support for 5 seconds. By the time of the data cutoff, a total of 26 patients were registered. Their age was 28.5 days (central value), and they were diagnosed with SMA based on genetic testing but had no symptoms. Evrysdi, the first PO option as an SMA treatment, has the advantage of being able to be customized according to age and weight. The process of registering insurance benefits is still slow. It is not on the HIRA's public list of any committees. It remains to be seen whether Evrysdi will be able to expand its coverage in 2023 along with the expansion of the indication. Meanwhile, Biogen's Spinraza and Novartis' Zolgensma are currently listed in the SMA area in Korea.
- Policy
- Lucentis biosimilar enters KRW 35B market in Korea
- by Lee, Tak-Sun Dec 21, 2022 06:05am
- Samsung Bioepis’s Lucentis biosimilar that was released in the US in June Competition in the macular degeneration treatments market is expected to intensify with the imminent entry of the first biosimilar of ‘Lucentis’ in the Korean market. Sales of Lucentis alone had been nearly KRW 35 billion in Korea last year. Lucentis biosimilars from Chong Kun Dang and Samsung Bioepis were preannounced to be listed for reimbursement starting next month. According to industry sources on the 20th, the Ministry of Health and Welfare issued an administrative notice announcing the partial amendment to the reimbursement standards of some pharmaceuticals that included the introduction of Lucentis biosimilars. Previously, 2 Lucentis biosimilars were approved in Korea this year. Samsung Bioepis first received approval for its biosimilar under the name ‘Amelivu inj’ in May, followed by Chong Kun Dang’s ‘LucenBS inj’ in October. Both products are expected to be released with reimbursement next month. Like Lucentis, the two biosimilars will be reimbursed for all 4 indications: neovascular wet age-related macular degeneration (AMD), macular edema caused by diabetes, macular edema caused by retinal vein occlusion, and choroidal neovascularization secondary to pathologic myopia. Amelivu will be sold by Samil Pharmaceutical, which specializes in ophthalmic treatments. Samsung Bioepis and Samil Pharmaceutical signed a commercialization agreement for Amelivu in June this year. LucenBS is the second biosimilar to be developed by Chong Kun Dang. Its first biosimilar product,’Nesbell,’ which is a biosimilar of the anemia treatment NESP, was approved in November 2018. Considering the considerable size of the domestic market for Lucentis in Korea, Chong Kun Dang is expected to launch a large-scale marketing campaign to take a share of the market. The domestic macular degeneration treatment market is currently shared by two products – Bayer’s ‘Eylea,’ and Novartis’s Lucentis. According to IQVIA, their sales last year were KRW 70.5 billion for Eylea and KRW 35.1 billion for Lucentis. The global macular degeneration treatment market size is around KRW 13 trillion. This is why domestic biosimilar companies are also eyeing the global market. Samsung Bioepis released its Lucentis biosimilar ‘Byooviz’ in June in the US and is planning to also advance into the European market. In the case of Chong Kun Dang, the company is working to advance into Japan and Southeast Asia. Also, Celltrion, Sam Chun Dang Pharm, and Samsung Bioepis are developing Eylea biosimilars.
- Policy
- Shingrix will be released as a national lot on the 16th
- by Lee, Tak-Sun Dec 21, 2022 06:05am
- GSK shingles vaccine against herpes zoster preventionShingrix (GSK), a shingles virus vaccine, received a national lot release on the 16th and began full-scale vaccination. It was also stocked in general hospitals, and vaccinations began this week. On the 16th, the Ministry of Food and Drug Safety released four production numbers (six in total, 0.5ml in packaging) with an expiration date of October 31, 2024. The National lot release is a system in which the Ministry of Food and Drug Safety allows only suitable items to be sold through quality inspection. Shingrix products approved for shipment were immediately stocked at general hospitals and vaccination began this week. GSK held a press conference on the 15th to commemorate its launch in Korea. In Korea, GC Pharma and Kwang Dong sell together. Shingrix is the first shingles vaccine in Korea that has been approved by combining GSK's immune enhancer with a non-live antigen. Two global phase 3 (ZOE-50 and ZOE-70) conducted on 15,411 adults over the age of 50 have a 97.2% preventive effect and more than 90% preventive effect in all age groups over the age of 70. This is because existing commercially available products have a preventive effect of less than 70%. It is known that the price is a little high. Shingrix is inoculated twice every two months, and it is known to cost about 500,000 won for two vaccinations. Zostervax, which is most commonly used to prevent shingles, is only inoculated once and sold for about 150,000 won.
- Opinion
- [Reporter’s View] Preserve the industry's willpower
- by Dec 21, 2022 06:05am
- Even before the world was able to recover from the COVID-19 pandemic, a global economic recession has arrived to further the damage. With the rise in the price of raw materials, the price of every single consumable including food such as flour, sugar, and cooking oil, as well as fuel, utility bills, etc. have risen. Every day, you can see a flood of articles that report “the price of noodles has risen” or that “eggs cost a fortune these days.” In the age of rising prices, only the price of pharmaceuticals seems to be on the decline. In Korea, the price of pharmaceuticals is on a constant decline under strong state control. The only exception was the price of cold medicine. Their price was recently raised due to a surge in demand for cold medicine during the COVID-19 pandemic. This premium pricing was proposed by the government as a ‘joker card’ to incentivize companies that were reluctant to manufacture more cold medicine due to concerns over deficits. The increase, which was a mere KRW 40 raise from the previous KRW 50 to KRW 90, was a rare exception made under special circumstances. Looking at the government’s recent policy direction, the prospects for pharmaceuticals are even dimmer. More drugs will be subject to reimbursement reevaluations that had significantly affected domestic pharmaceutical companies. Choline alfoscerate drugs have already taken a blow, and other ingredients including streptokinase, almagate, and avocado-soya have been subject to reevaluations and received reductions in their scope of reimbursements or price cuts. These reevaluations are expected to continue on next year. New drugs are not much better off, either. The government recently announced plans to include Australia and Canada as drug price reference countries. Australia is known to have one of the lowest drug prices among developed countries. As the drug prices in Australia are similar to or lower than that of Korea, the industry had criticized how the government is seeking to add these countries to further lower the state’s pharmaceutical expenditures. Industry concerns are rising on how if Australia is included as a drug price reference country, drug prices in Korea, which are already on the lower side in the global market, will be set even lower. While manufacturing and distribution costs are all on the rise, it is clear that the price of end products, the medicines, will continue to fall in Korea. Even the development of new drugs is not easy to carry out. Biotechs specializing in new drug development have also been experiencing a series of hardships. Investments dried up due to concerns over a prolonged economic downturn, and the listing has also become increasingly difficult. CEOs of bio companies are worrying about their business in the coming year. Clinical results do not come out right away, and they need to hold on to the depleting investment funds no matter what. Most of them are in a position to worry about corporate survival. Has the government already forgotten its big talk on how the pharmaceutical and bio-industry is the next-generation growth engine amid concerns over an economic recession? With the government tightening up regulations on the industry contrary to its promise, the industry is grappling for survival in the narrowing market. Despite the hardship, the industry had produced 35th and 36th homegrown new drugs and presented new candidates in the largest Asian oncology society meeting this year. However, these achievements were only made by a select few large pharmaceutical companies, which goes to show how much more support will be needed to nurture the growth of the domestic pharmaceutical bio industry. The ‘Impossible is Nothing’ campaign that became so popular with the World Cup described the importance of willpower. However, in the case of the pharmaceutical and bio-industry, it is rather the government’s willingness to preserve the industry's willpower that’s so important.
- Company
- Organon sold 3 types of infertility & contraceptives
- by Dec 21, 2022 06:05am
- Organon announced on the 19th that it will conduct direct sales and marketing of infertility and contraceptive products. According to Organon, the company will directly sell and market the infertility treatments Puregon and Organutran, and the implantable contraceptive Impranon in the body from next year. The company explained that it is a strategic business decision to realize the promotion of women's health. The goal is to strengthen competitiveness in infertility and contraception markets, including existing women's health products. Impranon will start direct marketing on January 1, 2023. Puregon and Orgalutran will be in charge of Organon Korea after the co-promotion contract with Han Wha, scheduled for the first half of next year. The three products that are converted to direct sales are representative infertility and contraceptive drugs sold in Korea over the past 20 years. Puregon has established himself as a representative of follicle-stimulating hormone, an ovulation-inducing agent. Orgalutran is a GnRH antagonist and has been used to prevent early ovulation spikes in women undergoing hyperovulation induction for assisted reproduction.Impranon is a long-term persistent reversible contraceptive inserted under the skin, with a 99% contraceptive effect lasting up to three years. CEO Kim So-eun said, "We will make significant progress in promoting women's health by strengthening expertise and differentiating based on various women's health product portfolios."
- Company
- Verzenio attempts reimb in early breast cancer in Korea
- by Eo, Yun-Ho Dec 20, 2022 06:06am
- The anticancer drug ‘Verzenio’ is attempting reimbursement listing for early breast cancer in Korea. According to industry sources, Lilly Korea has recently submitted an application for the reimbursement listing of its CDK4/6 inhibitor ‘Verzenio (abemaciclib)’ as a treatment for early-stage breast cancer with a high risk of recurrence. The company has been rapidly progressing its reimbursement procedure since the drug’s indication was expanded last month. The drug was approved by the Ministry of Food and Drug Safety as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence, in combination with endocrine therapy. Verzenio’s efficacy in early breast cancer was demonstrated through the monarchE trial. The Phase III monarchE trial was the only trial to confirm successful results in 20 years as an adjuvant treatment for HR+/HER2- early breast cancer in combination with endocrine therapy in 20 years. The results from Cohort 1 of the monarchE trial, which became the basis for the indication expansion last month, showed that Verzenio+endocrine therapy not only demonstrated a reduction in the risk of recurrence compared to endocrine therapy alone through an improvement in invasive disease-free survival (IDFS), but it also confirmed a reduction in risk of remote recurrence through an improvement in distant relapse-free survival (DRFS). Joohyuk Sohn, Professor of Medical Oncology at Severance Hospital said, “Early breast cancer patients mainly experience recurrence after primary treatment in their first 1-2 years. This is why these patients need a more effective adjuvant treatment to reduce the risk of recurrence and death. An unmet medical continued to exist in the field due to a lack of new treatment options for patients with HR+/HER2- early breast cancer after the introduction of aromatase inhibitors in the early 2000s." Verzenio is currently reimbursed in Korea for the treatment of HR+, HER2- advanced or metastatic breast cancer ▴ in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy; ▴in combination with Faslodex for women with disease progression following first-line therapy.
- Policy
- Pfizer & Novartis generic drugs disappear from the market
- by Lee, Tak-Sun Dec 20, 2022 06:06am
- All generic drugs released by Novartis and Pfizer Korean branches in the domestic market have disappeared. Although it was successfully released, it is interpreted that it left the market after losing a lot of competition with domestic pharmaceutical companies. According to industries on the 19th, Novartis' Pneumast 10mg and Pneumast 3mg were removed this month due to voluntary withdrawal of item permits. Pneumast is an organon asthma treatment Singulair generic drug licensed by Novartis Korea in October 2012. In the domestic market, Singulair generic was released in December 2011. Pneumast came out belatedly, and it is analyzed that it failed to show off its presence among numerous domestic generics. Sandoz, a generic subsidiary that Novartis recently decided to spin off, has also withdrawn from the Singulair generic business in the Korean market. As the benefit of Pneumast of Novartis Korea was deleted, all generic drugs under the name of Novartis Korea disappeared. Earlier in June 2020, Novartis withdrew its license to treat hyperlipidemia, Atorvin. Atorvin is Viatris' Lipitor generic drug. Pfizer also lost all generic drugs in a few years. Pfizer introduced Pfizer Vitals, a generic brand, in 2012. It was a business that LG Chem produced and sold licensed products by Pfizer. All products that were approved at that time have disappeared. Norvasc V withdrew the permit due to the Balzartan impurity incident in December 2019, followed by Montelu V in February 2020, Cilo V in May 2021, and Clo V in December 2021. In addition, in December 2021, Norvasc T, a high blood pressure compound, was involved in the false preparation of Jeil's data, and the license was revoked. As a result, domestic generics of Pfizer and Novartis have all disappeared. "At first, foreign pharmaceutical companies put forward their brands and quality through quality generics, but it was difficult to compete with domestic pharmaceutical companies with large hospital distribution networks based on their sales power," said an official in the domestic pharmaceutical industry.
- Company
- MSD-Boryung Bio will copromote Prodiax 23 in Korea
- by Dec 20, 2022 06:05am
- On the 19th, MSD Korea announced it has selected Boryung Biopharma as its new distributor and supplier for its pneumococcal vaccine, ‘Prodiax 23.’ Under the agreement, Boryung Biopharma will be distributing and supplying both the private and contract Prodiax 23 products under the National Immunization Program starting January 1, 2023. MSD Korea’s copromotion agreement with its previous supplier, HK.Inno.N, is set to end at the end of this year. MSD Korea explained that the agreement had been made after reviewing the company’s vaccine product portfolio and long-term strategy from various angles. Boryung Biopharma’s main portfolio consists of vaccines and biological agents and owns a stable cold chain system. MSD Korea believed that Boruyng Biopharma’s experience in directly supplying flu vaccines for the NIP will create a synergy effect. MSD’s 23-valent pneumococcal polysaccharide vaccine, Prodiax23, was approved in 2000. The vaccine covers the widest spectrum of serotypes among pneumococcal vaccines available in Korea. People aged 65 or older may receive pneumococcal vaccines for free under the NIP. Jaeyong Cho, Executive Business Unit Director of Vaccines at MSD Korea, explained, “The interest and demand for our pneumococcal vaccine has been rising in line with the rising public interest in infectious respiratory diseases. Our agreement with Boryung Biopharma was made to instantly and actively respond to this rise in demand.”
- Policy
- President Yoon said, block medical shopping
- by Kang, Shin-Kook Dec 20, 2022 06:05am
- As concerns arose that it might lead to a reduction in health insurance coverage, President Yoon Suk Yeol mentioned a second plan to reform health insurance. Regarding the direction of health insurance reform at the first state affairs inspection meeting at the Blue House guesthouse on the 15th, President Yoon said, "It means that we will eliminate it and re-define the insurance system because moral hazard hurts other good insurance subscribers." President Yoon said, "When I and my family have a serious disease that is really expensive, we will normalize the health insurance system to get proper treatment and recover health without worrying about the money (treatment cost)." "There is a person who goes to the hospital thousands of times a year because it is so-called medical shopping." In addition, there are cases where expensive MRI (Magnetic Resonance Imaging Device) is used indefinitely, he said. "We want insurance subscribers to receive fair support for serious diseases and essential medical care." President Yoon said, "I don't think it's desirable for us to set up a principle called the Medical Judgment Rule and treat it according to normal medical judgment. We'll design and operate a very effective objection procedure system for screening and evaluation." Health and Welfare Minister Cho Kyu-hong, who attended the National Policy Task Inspection Meeting, also stressed that the recent measures to improve the sustainability of health insurance do not reduce the role of health insurance. Minister Cho said, "What the government is trying to reorganize is to provide essential and severe medical care to the public as it is, not to reduce its role, but to improve sustainability," adding, "However, it is to prevent medical abuse or theft of qualifications." The Ministry of Health and Welfare held a public hearing on measures to improve health insurance sustainability and support essential medical care on the 8th and announced measures to recognize benefits only when medical needs are recognized in large-scale items such as paid brain and cerebrovascular MRI and ultrasound. When the Yoon Suk Yeoln government formalized health insurance reform that virtually abolished the so-called "Moon Jae In Care" (a policy to strengthen health insurance coverage), the opposition party strongly protested, saying that there was no case of reducing coverage in the conservative government.
- Company
- Shingrix presents a new paradigm for shingles prevention
- by Eo, Yun-Ho Dec 20, 2022 06:05am
- Professor YoonKorea GSK's herpes zoster vaccine "Shingrix" announced its official launch. GSK held a press conference at InterContinental Seoul COEX on the 15th to commemorate the launch of Shingrix, a shingles-prevention vaccine, in Korea. At the meeting, Yoon Kyung-young, an infectious medicine professor at Korea University Anam Hospital, introduced the epidemiology of shingles, the risk of diseases and complications, and strategies to prevent shingles through unmet needs and vaccines. Shingles occur when the varicella-zoster virus, a chickenpox-causing virus, is reactivated. Shingles are accompanied by unbearable pain, and some patients may experience neuralgia (post-shingles neuralgia) that lasts for months to years even after the shingles rash disappears. Professor Yoon said, "The risk of shingles is increasing in the elderly, where the immune system is strong and cannot maintain an effective immune response due to aging. "In the elderly and immunodeficiency cases, chronic pain caused by neuralgia after shingles, as well as complications such as invasion of eye nerves, facial paralysis, and damage to the auditory nerve are often leading," he explained. In addition, "Sherpas zoster complications lower the quality of life of patients, so it is important to prevent it in advance as a shingles vaccine." Shingrix emphasized that it will present a new paradigm for preventing herpes zoster in Korea as the first and only recombinant inactivation vaccine in Korea that has proven its preventive effect and safety profile through global clinical research. Under the theme of "Major Clinical Research Results of R&D and Shingrix in Recombinant Shingles Vaccine (RZV)," Kim Hyung-woo, managing director of GSK Medical Department, explained the implications of Shingrix's innovative mechanism and development. Shingrix, a Recombinant Zoster vaccine, is the first shingles vaccine in Korea approved by combining GSK's immune enhancer with a non-live antigen. It can help prevent the risk of developing shingles in adults over the age of 50 due to naturally weakened immunity due to aging. Shingrix showed 97.2% preventive effect in two global phases 3 clinical trials (ZOE-50, ZOE-70) conducted on 15,411 adults over the age of 50, and more than 90% preventive effect in all age groups over the age of 70. Significant adverse reactions were similar in the Shingrix administration group and the placebo administration group. An interim analysis of ZOSTER-049 (ZOE-LTFU) conducted by an extensive study of ZOE-50 and ZOE-70 confirmed that the shingles-prevention effect of Shingrix persists for at least 10 years after initial inoculation. In addition, Shingrix confirmed the safety profile through five clinical trials targeting immunocompromised people aged 18 or older. Based on this, Singrix can be vaccinated even in immunosuppressive diseases such as autologous hematopoietic stem cell transplant patients, solid cancer, blood cancer, and solid organ transplant patients, which have a higher risk of shingles than the general public. "Based on a number of clinical results, Shingrix is an innovative vaccine that is recommended to prevent shingles in adults over 50 years of age, not only in the United States but also in Canada, Germany, and the Netherlands, so it can be an effective alternative to prevent shingles in Korea," Kim said. Meanwhile, Shingrix was approved by the Ministry of Food and Drug Safety in September last year. It can be used for the purpose of preventing shingles in adults over 50 years of age or over 18 years of age who are at high or expected to have an increased risk of shingles due to immunodeficiency or immunosuppression due to disease or treatment. It is available in more than 20 countries worldwide, including the United States, Canada, Germany, Belgium, Australia, and Japan. In Korea, vaccinations are expected to be available at major general hospitals, hospitals, and clinics across the country starting this week.
