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- 2026-04-11 14:02:56
- Policy
- Ponesimod's Domestic Item License
- by Lee, Hye-Kyung Oct 12, 2022 05:50am
- Ponesimod of Janssen Korea, a rare drug for treating multiple sclerosis, has been approved for domestic items. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 11th that it has approved Ponesimo for the treatment of recurrent dysplasia in adults. The drug has been shown to reduce inflammatory reactions by blocking lymphocytes from being separated from lymphatic organs and inducing the number of lymphocytes in peripheral blood to decrease rapidly. Ponesimo is expected to reduce the occurrence of new diseases in patients with multiple sclerosis and prevent additional disorders from occurring and accumulating due to repeated and continuous symptoms. Ponesimo was designated as a rare drug in Korea on October 1 last year after being approved by the U.S. FDA in March last year as a treatment for adult patients with recurrent multiple sclerosis, including clinical solitary syndrome, recurrence-relaxation disease, and active secondary progressive disease. The Ministry of Food and Drug Safety said, "We expect that this rare drug license will contribute to improving the quality of life of patients by expanding their treatment opportunities and options." The Ministry of Food and Drug Safety said, "We will do our best to expand treatment opportunities to patients such as rare and incurable diseases by quickly supplying treatments that have been sufficiently confirmed in safety and effectiveness based on regulatory science expertise."
- Policy
- Alvogen’s Alymsys reimbursed...compete with Avastin similar
- by Lee, Tak-Sun Oct 12, 2022 05:50am
- Samsung Bioepis’s Avastin biosimilar Competition for biosimilars of the anticancer drug Avastin (bevacizumab) is intensifying in the domestic market. Alvogen’s ‘Alymsys’ is making a bid against Samsung Bioepis’s ‘Onbevzi,' which had been dominating the Avastin biosimilar market. With the entry of Alymsys, the original Avastin and its two biosimilars will be competing in the market. According to industry sources on the 11th, Alvogen Korea’s ‘Alymsys inj.’ will be included on the NHI reimbursement list starting this month. The maximum reimbursement price for the 0.1g dose will be KRW 208,144 per vial, the same as Samsung Bioepis’s ‘Onbevzi inj.’ The price of the 0.4g dose was also set at KRW 677,471, the same as Onbevzi. The price of its original, Roche’s Avastin inj is set at KRW 218,782 for the 0.1g dose and KRW 712,098 for the 0.4g, which is slightly higher than its biosimilars. Onbevzi enjoyed a monopoly in the biosimilar market for 1 year after being approved for reimbursement in September last year, and enjoyed a significant preoccupation effect in the market. Its sales, which reached KRW 0.5 billion in Q4 last year based on IQVIA, had continued rising to KRW 1.8 billion in Q1, and then KRW 4.1 billion in Q2. At this rate, its sales is expected to exceed KRW 10 billion only one year since its launch. With the launch of Onbevzi, Avastin’s price was also discounted. With the price reduction, its sales also dropped by KRW 20 billion from the KRW 58.9 billion in 1H of the previous year to KRW 38.1 billion in the 1H this year. Avastin is a targeted therapy monoclonal antibody that is widely indicated for the treatment of various cancers including ▲metastatic colorectal cancer, ▲metastatic breast cancer ▲non-small-cell lung cancer ▲advanced or metastatic renal cell carcinoma, ▲glioblastoma, ▲epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, ▲uterine cervical cancer, etc. Its market size exceeds KRW 100 billion in Korea. Due to its potential, biosimilar companies that had mainly stayed abroad have been launching large-scale marketing activities in the Korean market. However, Avastin’s patent emerged as a variable. Due to the patent, biosimilars were restricted from being used like the original drug, in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin for the ovarian cancer indication. Samsung’s Onbevzi was also unable to obtain this indication due to unresolved patent issues earlier in its release. On the other hand, Alvogen’s Alymsys was approved with the said indication. This is why the release of Alymsys was expected to weaken the competitiveness of Onbevzi in the market. But the situation was once again reversed with Samsung reaching an agreement on patent issues with the original developer Genentech, and Alvogen failing to do so. Samsung recently reached an agreement with Genentech for the patent suit on Avastin, which had been ongoing since June 2020. As a result, the company was able to obtain an additional indication for epithelial ovarian cancer last month. Alvogen, on the other hand, had to delete the indication in August due to a patent dispute and received reimbursement approval for the remaining indications. This is why the reimbursement approval period was delayed by one month. Despite some indication-related issues, many experts expect biosimilars to succeed in the domestic market, considering the high usage rate of bevacizumab in various other cancers as well. Samsung Bioepis entrusted sales of its product to Boryung Pharmaceutical, which is showing prominence in the anticancer drug market, and Alvogen to the large domestic pharmaceutical company Daewoong Pharmaceuticals for its early settlement in the market. In addition, Celltrion also received approval for its ‘Vegzelma inj’ on September 28th and is working to release the drug with reimbursement within the year. Celltrion also reached an agreement on Avastin’s patent with Genetech in May and was approved for the same indication as the original, including ovarian cancer related indication. Until now, Remsima was the only product that showed a good performance in the domestic biosimilar market. It is analyzed that the domestic biosimilar market is also entering full-fledged growth, starting with the Avastin biosimilar.
- Company
- Reimb for Ilaris unclear... benefits 13 patients in Korea
- by Eo, Yun-Ho Oct 11, 2022 05:51am
- As well expected, no progress has been made in reimbursing ‘Ilaris,’ an orphan drug that affects 13 patients in Korea. According to industry sources, reimbursement discussions for Ilaris (canakinumab), Novartis Korea’s Hereditary recurrent fever syndrome treatment that the company applied for in the first half of the year is making slow progress. The company had reapplied after receiving a non-reimbursement decision from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in 2017, but the government nor the company seems to be finding a way. Among the various specific syndromes that accompany a hereditary recurrent fever, Ilaris is approved in Korea to treat ▲Cryopyrin-Associated Periodic Syndromes (CAPS), ▲Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), ▲ Familial Mediterranean Fever (FMF) due to contraindication, intolerance or lack of efficacy. Although the drug had demonstrated an improvement in quality of life and convenience in administration with its 6-times-a-year administration in CAPS patients, the drug had difficulty proving its cost-effectiveness, being a treatment for an ultra-rare condition and because a relatively cheaper option ‘Kineret (anakinra)’ is being supplied through the Korea Orphan & Essential Drug Center. In fact, Novartis first applied for reimbursement in 2017 after it was initially approved in 2015. However, the company did not proceed with the reimbursement process again until recently after the setback in 2017. Anticipation had risen for its reimbursement with the reapplication filed this time but to no avail. Unlike Kineret which is administered every day, Ilaris offers a more convenient option to patients and carers alike, as it is administered every 8 weeks. Dae-Chul Jeong, Professor of Pediatrics at Seoul St.Mary’s Hospital, said, “Access to such treatments needs to be improved so that patients with hereditary recurrent fever in Korea are guaranteed the same right to receive treatment as other patients with rare diseases. In addition, “Patients with hereditary recurrent fever are diagnosed after a difficult journey. We need to provide social attention and support so that patients can maintain the quality of life with their families without being discouraged at the threshold of treatment." Meanwhile, in a clinical study, 97% of the patients that were administered Ilaris 150mg achieved a complete clinical response by Week 8 through a single administration during the open-label study period. In the double-blind, placebo-controlled study period, all patients who were administered Ilaris 150mg every 8 weeks maintained their complete response without relapse for over 6 months. Also, in a real-world study that was conducted in France that compared 68 adult and pediatric patients that received at least one dose of Ilaris at baseline, at 6 months and 12 months, over 40% of patients with CAPS who were treated with Ilaris showed an improvement in vitality such as social function, human relationship, and sexual activity, and the patient care period of carers reduced significantly.
- Company
- Hemlibra, emerged as an issue of the National Audit Office
- by Nho, Byung Chul Oct 11, 2022 05:50am
- As the administration of non-antibody patients has been delayed for more than three years since Hemlibra, an innovative new drug for hemophilia A, is expected to emerge as a topic of the parliamentary audit. Representative Kang Sun-woo (Democratic Party of Korea), a member of the Health and Welfare Committee, will question the issue of the benefit of hemophilia new drug Hemlibra at a parliamentary audit of HIRA held on the 13th of this month. Kim Kyung-Hwa, a mother of a hemophilia patient with type A as a representative of the Korean Hemophilia Association, will attend as a reference. She is expected to urge health authorities to apply for Hemlibra's delayed health insurance benefits, explaining the problems of existing treatments that should be used to prevent bleeding and why subcutaneous injections are needed at the National Audit Office. Hemlibra is used as a new innovative treatment for many hemophiliac patients, achieving the No. 1 global market share, but the application of benefits is being delayed in Korea. Hemlibra, a type A hemophilia treatment imported by JW Pharm in charge of domestic permission and sales, was first approved for sale as a treatment for antibody patients in January 2019 and was first listed in May 2020, and limited standards have been resolved several times since then. In September last year, the Anti-Corruption and Civil Rights Commission recommended a review of the standards, allowing young children to be prescribed Hemlibra without undergoing two to three years of intravenous treatment. The problem is that 90% of about 1,800 hemophilia A patients are non-antibody patients. Hemlibra added an indication for non-antibody patients in March 2020 and applied for benefits in July of that year, but health insurance benefits have not been used even after two years. According to the academic society and replotting organizations, the expansion of Hemlibra's standards was confirmed at the third subcommittee held at the Review Board in July. Looking at the clinical usefulness, Hemlibra judged that it was also worth paying for non-antibody patients. However, the future is a problem. Even if it has passed the subcommittee, it must go through the HIRA Drug Benefit Evaluation Committee and negotiate drug prices and usage with NHIS. Currently, the Drug Benefit Evaluation Committee does not know when it will be held. Hemlibra is the only existing hemophilia A treatment that has been approved for use as a preventive therapy for both antibody and non-antibody patients. It imitates the mechanism of action of the coagulation factor VIII with the first-in-class applied with the technique of simultaneously binding to the coagulation factors VIIII and X, Unlike conventional treatments that supplement the 8th coagulation factor with such a mechanism, antibody production is not risky. The patient's pain was dramatically improved when taking existing drugs with subcutaneous injections up to once every four weeks. In the case of conventional hemophilia treatments, intravenous injections should be performed at least twice a week. In August, the results of phase 3 clinical trials were published in Blood advises that hemophilia A patients with hemophilia administered with Hemlibra had fewer side effects of bleeding during surgery. The result is that the risk of bleeding during surgery is low in a situation where efficacy and safety have been proven as a law.
- Company
- Will the premium vaccine market rebound?
- by Kim, Jin-Gu Oct 11, 2022 05:50am
- Whether the premium vaccine market, which consists of vaccines used to prevent diseases like shingles, pneumococcal vaccines, etc., will be able to overcome the COVID-19 crisis and make a rebound is gaining attention. Expectations of market recovery are rising in the pharma and bio-industry with the eased resurgence of COVID-19, cautious expectations on the nearing end of the COVID-19 pandemic, and potential new product releases being in the two vaccine areas. ◆Shingrix expected to be released at the end of the year...Will the contracted market rebound after COVID-19 According to industry sources on the 8th, GSK and GC Pharma plan to jointly promote the sales of the new shingles vaccine, Shingrix. Shingrix is a vaccine that prevents shingles in immunocompetent adults 50 years and older, and adults 18 years and older who are or will be immunocompromised. GSK received approval for the drug from the Ministry of Food and Drug Safety in September last year. Although the company had originally planned to release the drug in February this year, the schedule was delayed. Currently, two products - MSD's ‘Zostavax’ and SK Bioscience's ‘SKYZoster’ – are competing in the domestic shingles vaccine market. MSD The market had greatly contracted with the prolonged COVID-19 crisis. The continued prioritization of COVID-19 vaccines resulted in a relative neglect of other vaccine products. According to the medical research institution IQVIA, the domestic shingles vaccine market, was KRW 89.9 billion in 2019, a 3% increase from that in 2018. However, since the outbreak of the COVID-19 crisis, the market size shrunk for two consecutive years to KRW 72.3 billion in 2020 and KRW 45.1 billion in 2021. Compared to 2019, right before the COVID-19 crisis, the market shrunk to nearly half in two years. ◆Applying NIP to shingles vaccine under review... expectations rise for market expansion The pharmaceutical industry predicts that the market will normalize after next year after the COVID-19 crisis starts settling down. In particular, as the Suk-Yeol Yoon administration is reviewing including the shingles vaccine in the National Immunization Program (NIP), some are projecting that the market will further expand, even to a greater extent than before the COVID-19 crisis. During the elections, President Suk-Yeol Yoon who had been a candidate then had pledged to apply NIP to shingles vaccines. Quarterly sales of shingles vaccines in Korea(Unit: KRW 0.1 billion, IQVIA) The key point of the issue is how much influence the third shingles vaccine will exert in the market. By vaccine effect, Shingrix has a higher prevention rate than the existing two products. The prevention effect of Shingrix, which is indicated for adults aged 50 years and older were found to be 97% at 3.2 years after vaccination in the ZOE-50 clinical trial. Its competitor, Zostavax has shown a 51% preventive effect in adults aged 50 years or older and a 41% effect in adults aged 70 years or older. SKYZoster has demonstrated non-inferiority to Zostavax in a clinical trial. By prevention rate, the vaccine has no significant difference from Zostavax. However, its price is expected to be higher than that of existing vaccines due to its excellent preventive effect. Currently, the price of Zostavax is in the middle KRW 100,000 range, and SKYZoster is in the lower KRW 100,000 range. If the price tag of Shingrix is set too high, it may not enjoy a performance up to expectations in the market. At the same time, this will also act as a barrier to its entry into NIP. How well the two existing products will maintain their share of the market also remains to be seen. Currently, SKYZoster had been chasing Zostavax’s sales. SKYZoster’s shares in the market had been rising since it was released in Q4 2017. Shares of SKYZoster, which had been 35% in Q1 2018, rose 8%p and 43% in 4 years since Q1 this year. ◆MSD·Pfizer to introduce next-generation pneumococcal vaccines in Korea in full-scale New products are also soon to enter the pneumococcal vaccine market as well. Pfizer received marketing authorization for ‘Prevenar 20’ in the US in June last year. Prevenar 20 is an upgraded version of its existing product, ‘Prevenar 13.’ Prevenar 13 prevents 13 serotypes, and Prevenar 20 prevents 20 serotypes. MSD has also developed a next-generation pneumococcal vaccine. MSD received approval for its ‘Vaxneuvance’ from the US FDA in July last year. Vaxneuvance prevents 15 serotypes of Streptococcus pneumoniae. Although its scope of prevention is narrower than that of the existing vaccine 'Prodiax23', it has excellent preventive effects in that it is a conjugate vaccine, not a polysaccharide-based vaccine. The industry expects the two vaccines to be introduced to Korea after next year. MSD Korea submitted a market authorization application for Vaxneuvance in March of this year. Pfizer Korea is expected to apply for market authorization for Prevenar 20. An East Asian clinical trial with a total of 1,400 patients including 500 Korean patients are currently underway for Prevenar 20.
- Company
- Emergency Contraception (EC) monopolized by Hyundai
- by Oct 11, 2022 05:50am
- As generics enter the Emergency Contraception (EC) market, which is dominated by Hyundai Pharmaceutical, a maximum of five-way race is expected. Generics that avoided patents led by GL Pharma predicted full-scale sales this month. According to the pharmaceutical industry on the 8th, Arlico Pharmaceutical, The U, GL Pharma, and Kwangdong Pharmaceutical will release EC containing Ulipristal ingredients this month. They obtained an item license from the Ministry of Food and Drug Safety in June last month. All are generics of Hyundai Pharmaceutical's Ellaone, and GL Pharma is in charge of producing all four products. GL Pharma was the first to obtain generic for Ellaone and then recruited companies to launch the generic together. In the process, the U, Arlico, and Kwangdong joined. GL Pharma filed a passive judgment in December last year on Ellaone's patent for Ulipristal after successfully developing a formulation that avoided the scope of Ellaone's patent. When the Korean Intellectual Property Tribunal cited the plaintiff's claim on September 14, not only GL Pharma but also three pharmaceutical companies that participated in the consignment secured generic for exclusion. Ellaone is an original ingredient of Ulipristal and was developed by French pharmaceutical company Laboratoire HRA Pharma and introduced by Hyundai Pharmaceutical in Korea. It currently generates the largest sales in the oral contraceptive market. Last year's sales amounted to 3.3 billion won. Norebwon (Levonorgestrel), is following with 2.2 billion won. The Emergency Contraception (EC)) market is largely divided into two active ingredients: Levonorgestrel and Ulipristal. Among the Levonorgestrel ingredient emergency contraception (EC) market, Hyundai Pharmaceutical exclusively occupied the Ulipristal ingredient. Hyundai Pharmaceutical's Ellaone patent expires in 2029. However, as GL Pharma succeeded in avoiding the scope of Ellaone patents last month, it advanced the release of generics by about seven years. From the fourth quarter of this year, GL Pharma is expected to be the biggest beneficiary when the Ulipristal market enters the generic competition system. GL Pharma is a pharmaceutical company specializing in sex hormone drugs and has been researching, producing, and supplying various contraceptives and sex hormone drugs over the past four years.
- Company
- The second CGRP migraine drug Ajovy's benefit is listed
- by Eo, Yun-Ho Oct 11, 2022 05:50am
- According to related industries, Handok Teva has begun negotiations with the HIRA on the drug price of Ajovy, a target migraine treatment for Calcitoningenene-related peptide (CGRP). Ajovy passed the HIRA Drug Benefit Evaluation Committee last month. Ajovy's drug price is expected to be negotiated as its competitive drug and first item, Emgality, was applied in September. If Ajovy succeeds in registering, competition for the prescription of the two drugs is expected to begin in earnest. Emgality and Ajovy are the same category of drugs, but there are differences in dosage, so they are being selected according to the characteristics of severe migraine patients. Emgality is administered 240 mg (two consecutive subcutaneous injections each of 120 mg) once at a loading dose, and then subcutaneous injections of 120 mg once a month. Ajovy 225 mg is used once a month or 675 mg (three consecutive times of 225 mg) is injected subcutaneously once every three months. Ajovy proved its validity through a 12-week HALO EM/CM clinical trial in 2,000 EM and CM patients. In a HALOEM study conducted to verify the efficacy and safety of Ajovy compared to the placebo group, Ajovy was evaluated to meet the primary evaluation variable by significantly reducing the number of monthly migraine occurrences in both monthly and quarterly administration groups. The proportion of patients whose average monthly migraine days decreased by more than 50% was also higher in the Ajovy monthly administration group and 44.4% in the quarterly administration group compared to 27.9% in the placebo group. In the HALOCM study, the average number of monthly headache reduction days in the Ajovy administration group was 4.6±0.3 days, and the quarterly administration group was 4.3±03 days, which was significantly reduced compared to 2.5±0.3 days in the placebo group.
- Company
- Only 2 out of 10 are prescribed monotherapy for diabetes
- by Kim, Jin-Gu Oct 07, 2022 06:04am
- The use of combination therapies in diabetes has been increasing further. Already, 8 of 10 patients are prescribed two or more drugs at once. In particular, the triple therapy combination regimen seems to be rapidly establishing its presence in the field. By ingredient, DPP-4 inhibitor class drugs are still showing strength, but their growth is gradually slowing down. On the other hand, SGLT-2 inhibitor class drugs are gaining influence, while sulfonylurea class drugs are on a steady decline. ◆From dual to triple therapies…the diabetes treatment paradigm is shifting The Korean Diabetes Association published a ‘2022 Diabetes Fact Sheet’ that contained the information above. Based on the national health insurance claims data, the Fact Sheet contains the prevalence, treatment rate, and drug prescription rate of diabetes in Korea from the year 2002 to 2019. Present status of Oral Hypoglycemic Agent combination therapies (Data: 2022 KDA Diabetes Fact Sheet) According to the data, the prescription rate of monotherapy in diabetes was 22.2% in 2019. 2 in 10 diabetes patients have been prescribed a single drug for their condition. The other 77.8% are receiving two or more drugs at once. The rate of combination therapy prescriptions had risen 5.4%p in 5 years from the 73.4% in 2014. In particular, the prescription rate of three-or-more drug combinations is on the rise. The three-or-more drug combination therapies that had been prescribed in only 31.9% of all cases until 2014, had risen 6.1%p in 5 years to 38.0%. In the same period, prescription of dual combination therapies had decreased by 1.7%p from 41.5% to 39.8%. Prescription of monotherapies had fallen 4.4%p in 5 years from the 26.6%. The gap between prescription of dual and triple combination therapies had been 9.6%p in 2014, which had been reduced to 1.8% in 5 years. The industry has been interpreting this as a shift in the diabetes treatment paradigm, of how the diabetes treatment paradigm is moving from dual combination therapies to triple combination therapies. This phenomenon is also reflected in the number of drugs that are initially prescribed after being diagnosed with diabetes. First drug prescription for diabetes after diagnosis (Data: 2022 KDA Diabetes Fact Sheet) In 2009, 66.7% of the patients first diagnosed with diabetes were prescribed monotherapy. The prescription rate of dual combination therapies had been 30.6%, and triple combination therapies 2.7%. In 2019, the prescription rate of monotherapies in those first diagnosed with diabetes had become 58.9%, a 7.8%p decrease in 10 years. On the other hand, the prescription rate of dual combination therapies had increased 4.9%p to 35.5%, and triple combination therapies 2.9%p to 5.6%. ◆Sales of metformin and DPP-4i surge... sulfonylurea sales fall, SGLT-2i rise By ingredient, metformin and DPP-4 inhibitor class drugs are still the most popular. As of 2019, 87.5% of all diabetes patients were prescribed metformin, followed by 63.9% receiving DPP-4 inhibitor class drugs, 41.7% sulfonylurea (SU), 11.6% TZD class, 10.8% SGLT-2 inhibitor class, 8.4% insulin (duplicate prescriptions reflected in the statistics). Compared to 5 years ago in 2014, the prescription rate of metformin increased by 2.1%p from 85.4% to 87.5%. In the case of DPP-4 inhibitors, prescriptions increased by 18.5%p from 45.4% to 63.9% in the same period. After it was first introduced in 2008, the prescription of DPP-4 inhibitors increased rapidly to reach 59.1% in 2016. However, since then, its growth slowed to 61.8% in 2017, 63.4% in 2018, and 63.9% in 2019. Analysis of prescription patterns by diabetes drug ingredient (Data: 2022 KDA Diabetes Fact Sheet) In the case of sulfonylurea, sales are on a constant decline. Although it had been the most-prescribed drug until 2009, the prescription rate of sulfonylurea started to slow down with the introduction of DPP-4 inhibitors. Due to this the prescription rate of sulfonylurea class drugs, which had reached 75.8% in 2009, fell to 51.2% in 2015, and then was overtaken by sales of DPP-4 inhibitors. Sales continued to decrease further to 41.7% in 2019. On the other hand, SGLT-2 inhibitor class drugs have been rapidly increasing their influence since their introduction in 2014. Their prescription rate, which had been only 2.4% in 2015, rose to 10.8% in 2019.
- Policy
- Two companies' Ticagrelor can be reimbursed
- by Lee, Tak-Sun Oct 07, 2022 06:04am
- Brilinta was released last monthAs Kukje and Korea United Pharmaceutical newly entered the anti-thrombotic Ticagrelor market, it was reorganized into a competitive system for nine companies. Although the original Brilinta's material patent expired in November last year, only six pharmaceutical companies' products entered the market due to high manufacturing costs and lack of marketability. And although generics for exclusivity ended last August, no news of generics' benefit was heard that month. According to the industry on the 6th, Kukjel has obtained benefits for Ticagrelor since September and Korea United Pharmaceutical from this month. Kukje is competing in the market with Brilor and Korea United Pharmaceutical with Tiglor. Competition, which had been stagnant due to their participation, has resumed. Currently, Hutex Pharmaceutical Korea, Alboven Korea, Hana Pharmaceutical, Samjin Pharmaceutical, Korea United Pharmaceutical, Kukjel, Genuonesciences, and Chong Kun Dang are competing in the market. Among them, Samjin, Korea United Pharm, Kukje Pharma, Genuonescience, and Chong Kun Dang are their own manufactured products, and the rest of the products are all entrusted to Genuonescience for consignment production. There are 41 licensed generics for Ticagrelor companies, but many consigned items are believed to have given up the market due to high raw material prices. Kukje and United Pharm, which have additionally been challenged, are analyzed to have solved the cost problem through their manufacturing. However, it is not a good situation for generic companies to succeed in the market. First of all, the Ticagrelor formulation market is gradually decreasing. Original Brilinta's outpatient prescription performance is gradually decreasing, with 10.8 billion won in 2019, 9.8 billion won in 2020 and 9.7 billion won in 2021. United is also seeking to expand its market by adding Tiglor to Clopidogrel-based Clavixin and Clavixin Duo. In the medical field, Ticagrelor does not have drug resistance due to existing clopidogrel CYP2C19 gene mutation It is believed that generics can sufficiently succeed in the market because it has the advantage of fast drug expression time.
- Company
- Lilly prepares to introduce Olumiant for hair loss in Korea
- by Eo, Yun-Ho Oct 07, 2022 06:04am
- JAK inhibitors may soon be prescribed to treat hair loss in Korea as well. According to industry sources, Lilly Korea is preparing to apply and expand the indication for its JAK inhibitor Olumiant (baricitinib) to severe alopecia areata to the Ministry of Food and Drug Safety. After the drug was approved in June for the indication by the US FDA, the company is quickly entering global commercialization. Olumiant selectively and reversibly inhibits JAK1 and JAK2 to reduce the expression of inflammatory cytokines and demonstrates an overall anti-inflammatory effect. It was first approved as a treatment for rheumatoid arthritis, then expanded its indication to atopic dermatitis in Korea and some other countries. In the US, Olumiant is also prescribed to treat hospitalized COVID-19 patients. Alopecia areata is also an autoimmune disorder that causes the body to attack its own hair follicles, resulting in hair falling out. In addition to scalp hair, eyebrows and eyelashes can also fall out. The efficacy of Olumiant in severe alopecia areata patients was demonstrated through the company’s BRAVE-AA1 and BRAVE-AA2 trials. The two trials evaluated the safety and efficacy of Olumiant in 1,300 patients compared with a placebo. In the AA1 trial, 22% of the 184 patients that took Olumiant 2mg, and 35% of the 281 patients that took Olumiant 4mg showed an appropriate level of scalp hair coverage and achieved a Severity of Alopecia Tool (SALT) score of 20 or less. The rate was only 5.3% in the placebo arm. The higher the SALT score, the more severe the degree of hair loss is considered to be. 31% and 35% improvements in eyebrow and eyelash coverage were also observed in the Olumiant 2mg and 4mg arm, respectively. In the AA2 trial, 17% of the Olumiant 2mg arm and 32% of the Olumiant 4mg arm achieved a SALT score of 20 or less, which was significantly higher than the 2.6% in the placebo arm. According to a Sungkyunkwan University report, around 25% of adults in Korea are known to have severe or worse alopecia areata, with less than 10% of these patients progressing to the extent that their hair almost falls out.
