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- 2026-05-07 05:50:55
- Policy
- Pharma companies with 'superior R&D·K-made drug ingredients
- by Lee, Jeong-Hwan Apr 26, 2024 05:48am
- Starting this year, under the 2nd comprehensive National Health Insurance Plan (hereafter, referred to as NHI Plan), the government will provide preferential drug pricing for new drugs developed by pharmaceutical companies with high R&D costs. Additionally, the plan will expand the scope of the risk sharing agreement (RSA) for severe diseases. This year’s plan includes offering preferential drug pricing for national essential medicines that use drug ingredients manufactured in South Korea. Additionally, it includes a process for promptly increasing the price of medicine with a supply shortage. On the 25th, the Ministry of Health and Welfare (MOHW) held the 9th Health Insurance Policy Review Committee, conducted a review, and made a decision on the implementation of the 2nd comprehensive National Health Insurance Plan 2024. This year's implementation plan for the NHI Plan consists of four major directions: ▲Ensuring essential healthcare supply and fair compensation ▲ Reducing healthcare disparities and ensuring a healthy life ▲ Improving the financial sustainability of health insurance ▲ Establishing a stable supply system and a good circulation structure. The plan includes the 15th primary task and the 75th detailed task. Based on stable financial management, the MHOW has announced plans to invest over KRW 1.4 trillion in essential medical areas this year to support the implementation of the four major tasks outlined in the previously announced healthcare reform measures. Will establish a stable supply chain·good circulation structure Pharmaceutical companies are expected to focus their attention primarily on this year’s NHI Plan, particularly on innovative new drugs and supply stabilization. The MOHW announced that it would improve the system for supporting the development of innovative medical technology that provides treatment options for diseases without treatment and also the system for addressing supply shortages. For innovative new drugs, the MOHW will specify the criteria for innovativeness, aiming to offer a flexible scope for the consideration of economic evaluation. The plan will provide preferential pricing for drugs developed by pharmaceutical companies with a high proportion of R&D investment. It also includes measures to expand the scope of RSA for treatments used to treat severe diseases that irreversibly worsen the quality of life. In terms of stabilizing supply shortages, the plan will set the basis for providing preferential drug pricing for national essential medicines that use ingredients manufactured in South Korea. And it will also include a process for promptly increasing the prices of drugs with supply shortages. In addition, it will establish a system for selecting and monitoring essential medical supplies facing shortages. In terms of medical devices, the plan involves expanding the deferment criteria and period for innovative medical devices' evaluation and extending their pre-use period in medical settings. Furthermore, it aims to expand the utilization of the National Health Insurance data for public and scientific research purposes and for self-directed health management. It will also support international cooperation efforts. The plan involves increasing the provision of big data to private entities, allowing the external transfer of low-risk pseudonymized information, and supporting the utilization of medical data through health information highways. This year’s National Health Insurance fund is estimated to be KRW 2.6 trillion, currently in the black. However, the MOHW announced plans to manage the finances efficiently, considering prolonged use of the emergency medical system, changes to medical usage, and other circumstances. Additionally, over KRW 1.4 trillion will be invested in this year’s essential healthcare field. The MOHW will ensure stable finance management and support the implementation of the reform package announced in February. In Q1, over KRW 1.12 trillion will be invested to strengthen compensation in shortages such as childbirth, pediatrics, and critical emergencies. Additionally, in Q2, more than KRW 27.6 billion will be allocated to enhance compensation in medical fields focusing on severe disease and essential healthcare. In Q3, KRW 50 billion will be invested to compensate the field focusing on severe psychological disorders. In Q4, over KRW 150 billion will be invested to expand the implementation of an alternative payment system to solve the regional and essential healthcare gaps. Will provide essential healthcare·reasonable compensation Investments will be increased in pediatric surgery and treatments, as well as in closed wards within tertiary general hospitals with high workloads and resources but relatively low evaluation. In 2023, medical institution revenue and expenses, the impact of the third phase of relative value unit revision, the expansion of panel hospitals, and cost surveys and analyses for fee adjustments will be analyzed. The results report is scheduled to be released in the second half of this year. A public policy cost will be introduced to maintain maternity infrastructure and to sustain personnel and facilities in the severe pediatric field. The MOHW plans to implement six pilot businesses with an alternative payment system. This system will offer differential compensation based on the quality of medical assessments and the achievement of treatment goals, not quantity. In detail, the post-management compensation of the hospitals offering services of children’s public specialized medical centers will be expanded from 9 to 14 hospitals. The first-year business will be implemented for hospitals participating in strengthening cardio-cerebrovascular disease network and a medical system for severe diseases. The implementation of a pilot business will be reviewed following a research on establishing a model for an emergency medical center·a mother and child medical center·a regional medical program pilot business. The MOHW also plans to establish a basis for payment system reform, including measures for innovative accounts or innovative centers and an achievement-centered review and evaluation system.
- Company
- LG Chem-EuBiologics will locally manufacture vaccines
- by Kim, Jin-Gu Apr 26, 2024 05:47am
- Heuisul Park, Head of LG Chem’s Specialty Care Business Unit (left) and Yeong-Ok Baik, CEO of EuBiologics (right) are posing for a photo to commemorate the signing of a CMO agreement LG Chem is joining hands with EuBiologics to speed up the development of pediatric combination vaccines that are being fully imported. LG Chem announced today that it has signed an agreement with EuBiologics to outsource the production of 'acellular Pertussis (aP)', the main antigen used for its hexavalent combination vaccine 'LR20062.’ LR20062 is being developed as a vaccine to prevent 6 infectious diseases: diphtheria, tetanus, pertussis, polio, meningitis, and hepatitis B. Compared to the pentavalent (diphtheria-tetanus-pertussis-polio-meningitis) vaccine commonly used in Korea, the hexavalent vaccine can be administered twice less. Under the agreement, LG Chem will provide aP strains to Eubiologics, and transfer the technology for the manufacturing process and testing methods. Eubiologics will supply the pertussis solutions to LG Chem, starting from those for LG Chem’s Phase III clinical trials. LG Chem will further invest in EuBiologics to build a GMP-certified facility to secure long-term supply. After commercialization, LG Chem expects to receive up to 20 million doses per year. Currently, LG Chem has completed a Phase I trial for ‘LR20062’ and expects to enter Phase II trials within the year. The Phase I trial confirmed LR20062’s comparable safety and immunogenicity to the existing hexavalent conjugate vaccine that the company has selected as a comparator. LG Chem explained, “We signed a CDMO agreement with EuBiologics to establish a stable domestic supply chain through timely development of combined vaccines in a situation where differentiated supply strategies overseas manufacturers implement in each country and stock shortage issues have an absolute impact on the supply of vaccines in Korea.” In fact, there is only one multinational pharmaceutical company that supplies hexavalent vaccines in Korea. Due to this, there has been a growing need for additional suppliers to meet the mid- to long-term demand. Based on the collaboration, LG Chem plans to commercialize LR20062 in Korea in 2030. Heuisul Park, Head of LG Chem’s Specialty Care Business Unit, said, “We plan to accelerate clinical development through close cooperation with EuBiologics, a leading domestic vaccine company. Amid rising concerns about vaccine shortage in Korea, we plan to actively contribute to creating an environment where our children can stably receive essential vaccines.”
- Company
- Forxiga prescriptions 'drop' after a 'withdrawal notice'
- by Kim, Jin-Gu Apr 25, 2024 05:50am
- (Clockwise from top-left) Product photos of Forxiga, Envlo, Dapalon, and Trudapa. The prescription sales of ‘Forxiga (dapagliflozin),’ an SGLT-2 inhibitor class treatment for diabetes, have declined to 22% over a year. After announcing its withdrawal from the Korean market at the end of last year, the company has distributed only the remaining stocks of Forxiga in South Korea, which may have impacted prescription sales significantly. Pharmaceuticals benefiting from Forxiga’s absence include generics, which were launched after Forxiga’s patent expiration last year, and Daewoong Pharmaceutical’s Envlo (ingredient: enavogliflozin), a new diabetes drug that falls into the same class as Forxiga. As of Q1 this year, Forxiga generics hold a 25% share of the SGLT-2 inhibitor market, while Envlo has expanded to 6%. Prescription sales of Foxiga in Q1 dropped by 22%...↑continued decline since the decision to withdraw from the Korean market According to the medical market research firm UBIST, Forxiga’s outpatient prescriptions in Q1 this year amounted to KRW 11.3 billion, a 22% decline over a year compared to KRW 14.5 billion in Q1 last year. The analysis suggests that the decline in the prescription performance of Forxiga can be attributed to the release of generics following Forxiga’s patent expiration and its withdrawal from the Korean market. Forxiga has been a top-selling drug in the market since competition in the SGLT-2 inhibitor market competition has started, expanding its prescription performance. Its sales peaked in Q1 last year, generating prescription sales of KRW 14.5 billion. Forxiga’s quarterly prescription sales (unit: 100 million, source: UBIST). However, its patent expiration in April led to release of generics into the market. Although the government’s 30% price reduction measure in response to generic releases was suspended via administrative litigation, generics containing the same ingredient have been expanding their presence in the market, shaking Forxiga’s position. Indeed, after the launch of generics, Forxiga’s sales began to trend downward. The decline in prescription performance in Q1 this year was further influenced by AstraZeneca Korea‘s decision to withdraw Forxiga from the Korean market. In December last year, AstraZeneca Korea made a decision to withdraw Forxiga from the Korean market. The company plans to withdraw Forxiga, a monotherapy drug, and only leave 'Xigduo,' a combination therapy drug containing metformin. Currently, AstraZeneca Korea only provides the existing stock without additional imports from the global headquarters. In Q1 of this year, supply decreased due to inventory depletion, leading to a significant decline in prescription performance. Monthly prescriptions for Forxiga decreased over time, from KRW 4.3 billion in December last year to 4 billion in January this year and to KRW 3.6 billion each in February and March. Forxiga gap, filled by domestic companies in South Korea… with generics accounting for 25% of the market share and Envlo for 6% As Forxiga, the market’s No.1 product, is set to withdraw from South Korea, other products are competing to fill the gap left by Forxiga. Analysis of the Q1 performance indicates that generics and Daewoong Pharmaceutical’s Envlo are emerging as contenders to fill this gap. In Q1 this year, Forxiga generics recorded a total of KRW 10.2 billion. After April last year, 64 Forxiga generics were launched. These products expanded sales rapidly, generating KRW 3.9 billion in Q2, KRW 6.8 billion in Q3, and KRW 8.3 billion in Q4. In Q1 this year, Forxiga generics expanded its market share to 25% in the entire SGLT-2 inhibitor monotherapy market (KRW 40.6 billion). This represents pulling market share to a quarter of the KRW 150 billion market size within just one year of its launch. Regarding product sales, Boryung’s 'Trudapa' and Hanmi Pharm’s 'Dapalon' have grown significantly. In Q1, Trudapa recorded prescription sales of KRW 1.2 billion, while Dapalon recorded KRW 1 billion. Moreover, Aju Pharm’s 'Daparil,' Chong Kun Dang Pharmaceutical’s 'Exiglu,' and Kyung Dong Pharma’s 'Dapazin' have recorded over KRW 500 million in Q1. However, the other Forxiga generics have very low prescription performance. In Q1, out of 64 generic products, 59 (92%) had less than KRW 500 million prescription sales. Among these, 41 products had less than KRW 100 million in quarterly prescriptions. The average amount prescribed for a generic product is about KRW 159 million. Trends in the prescription market for SGLT2 inhibitor (SGLT2i) class diabetes treatment (unit: KRW 100 million, source: UBIST). Daewoong Pharmaceutical’s Envlo is rapidly expanding its market share. Envlo’s Q1 prescription sales were KRW 2.6 billion (including the prescriptions of HanAll Biopharma’s 'Eaglex'). Envlo is the first SGLT-2 inhibitor developed in Korea, and it was launched in May. Envlo recorded KRW 500 million in Q2 last year, KRW 1.3 billion in Q3, and KRW 1.9 billion in Q4. In Q1 this year, it expanded its market share by 6% in the SGLT-2 inhibitor monotherapy market. Following Forxiga, 'Jardiance,' which ranked second in the market, also benefited. Jardiance’s Q1 prescription sales were KRW 15.3 billion, up 10% compared to KRW 13.9 billion in Q1 last year, becoming the No.1 in the market. However, Jardiance’s market share in the SGLT-2 inhibitor market decreased from 47% to 38%, a 9% drop. While prescription performance increased due to the absence of Forxiga, it is analyzed that it failed to expand market share because of competition from Forxiga generics and Envlo. The pharmaceutical industry expects the market share of Forxiga generics and Envlo to accelerate further after Q2 this year when Forxiga withdrawal begins in full swing. AstraZeneca Korea is anticipating the timing of domestic withdrawal once the remaining stock is depleted. As of Q1, the prescription sales gap, valued at over KRW 10 billion, will be divided between Forxiga generics and Envlo.
- Company
- Godex’s sales slow down due to various regulatory measures
- by Chon, Seung-Hyun Apr 25, 2024 05:50am
- Celltrion’s liver drug 'Godex' is experiencing a slump in the prescription market. At one point, its quarterly prescription sales exceeded KRW 20 billion but have been on a downward trend for the past 2 years. The company has been able to pass the health authorities' reimbursement reevaluations, but the drug price cut that followed left a performance gap. According to the market research institution UBIST on Thursday, outpatient prescriptions for Godex amounted to KRW 17.8 billion in Q1, down 1.3% year-on-year. Compared to the KRW 20.6 billion in Q1 2022, this is a 13.5% decrease in 2 years. Godex's prescription sales in Q1 were the lowest in the last 4 years, after reaching KRW 17.3 billion in Q2 2020. Godex is a reformulated drug developed by Celltrion’s former company, Hanseo Pharm in 2000. It is a combination drug consisting of 7 ingredients: adenine hydrochloride, riboflavin, biphenyl dimethyl dicarboxylate, cyanocobalamin, carnitine orotate, pyridoxine hydrochloride, and antitoxic liver ext. Godex is indicated for a variety of liver diseases with elevated transaminases (ALT), an indirect marker of liver cell damage, including alcoholic fatty liver disease, nonalcoholic steatohepatitis (NASH), inflammatory liver disease, and viral hepatitis. Quarterly Godex outpatient prescriptions (KRW: 100 million, Data: UBIST) Godex has been very popular in the prescription field, growing 48.6% over the past 2 years, from KRW 14.4 billion in prescriptions in Q1 2019 to KRW 21.4 billion in Q4 2021. From Q3 2021 to Q3 2022, the drug has recorded prescription sales of more than KRW 20 billion for 5 consecutive quarters. Godex has barely passed the health authorities' reimbursement reevaluations, but its growth has slowed down due to drug price cuts. In July 2022, the Health Insurance Review and Assessment Service determined that Godex was ineligible for reimbursement. However, after the company appealed, the authorities conducted a reevaluation of the drug’s reimbursement adequacy and concluded that Godex was eligible for reimbursement. However, in November 2022, the Health Insurance Review Committee gave a pending decision on the maintenance of Godex’s reimbursement, and a month later, the Health Insurance Policy Deliberation Committee concluded that Godex’s reimbursement should be maintained. During the reimbursement reevaluation process, Celltrion reached an agreement with the health authorities to reduce the drug’s insurance ceiling price by 12.4% from KRW 356 to KRW 312 from November 2022. Godex’s sales recorded KRW 21.2 billion in Q3 2022 but declined 7.1% to KRW 19.7 billion in Q4 due to the drug price cut, and growth stagnated thereafter. However, if the drug price cut rate is taken into account, its prescription volume is calculated to be at a similar level as before. Therefore, analysis suggests that confidence in the drug itself remains strong in the prescribing area, after being saved from reimbursement review.
- Company
- Lipitor’s sales stay strong for good reason
- by Son, Hyung-Min Apr 25, 2024 05:50am
- Bill Schuster, Country Manager of Viatris Korea The dyslipidemia treatment Lipitor has been able to remain the No. 1 selling drug for 20 years, supported by various clinical evidence. Lipitor has proven its efficacy in patients with dyslipidemia not only globally but also domestically. Based on various clinical evidence, major domestic and international societies still recommend statins as the preferred treatment for dyslipidemia. On April 24, Viatris Korea held a press conference at the Westin Josun Hotel in Seoul to celebrate the 25th anniversary of Lipitor's launch in Korea. Lipitor is the first atorvastatin-based dyslipidemia treatment that had been developed by Warner-Lambert (now Pfizer). Lipitor was approved by the U.S. Food and Drug Administration (FDA) in 1997 and launched in Korea in 1999. Lipitor works by competitively inhibiting the reductive component of HMG-CoA, a precursor for cholesterol synthesis, and hence disrupt the synthesis of cholesterol in the body. Although many dyslipidemia drugs have then entered the market, Lipitor has been the number one selling drug ever since its launch. According to market research firm IQVIA, Lipitor has been on a roll since 2013, surpassing KRW 100 billion in sales. Last year, Lipitor's sales reached KRW 195.7 billion. Among the many dyslipidemia drugs, Lipitor's success has been driven by the company's efforts to secure a wide range of clinical evidence. In addition to the benefits confirmed in global studies, Viatris (then Pfizer) also conducted clinical trials in domestic patients. In the AT-GOAL and AMADEUS trials, Lipitor was found to lower LDL-cholesterol and reduce the risk of cardiovascular disease in Korean patients. In the AT-GOAL trial, 425 Korean patients with dyslipidemia were followed for 8 weeks after being prescribed personalized dosages based on LDL-cholesterol levels and cardiovascular events, and risk group. Results showed that more than 80% of the patients reached their individualized LDL-cholesterol treatment goals within 4 weeks of taking Lipitor. In the AMADEUS trial, 440 patients with type 2 diabetes received tailored doses of Lipitor according to their LDL-C levels, a major cardiovascular risk factor. In the trial, more than 90% of patients reached target LDL-cholesterol levels after eight weeks of Lipitor treatment. In addition, Viatris launched a high-dose version of Lipitor (80 mg) and Lipitor Plus (atorvastatin-ezetimibe) to improve patient convenience. One of the biggest advantages of Lipitor is that it is the only statin that has a secondary cardiovascular prevention indication. Lipitor offers the benefit of reducing patients' risk for secondary prevention of coronary heart disease, including hospitalization for nonfatal myocardial infarction, revascularization, stroke, angina, and congestive heart failure. In addition, Lipitor can be used in adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease. Based on such clinical evidence, Korean and international societies such as the American Diabetes Association, the European Society of Cardiology, and the Korean coronary artery disease societies recommend statins as first-line agents with strong clinical evidence. Dr. Sripal Bangalore, Professor of Medicine at New York University School of Medicine, said, “Lipitor's cardiovascular safety has been established in several pivotal clinical studies over the past 25 years. There is still a great deal of use for Lipitor, not only for LDL-cholesterol reduction but also for the prevention of several cardiovascular diseases.” Hyun-Jung Lim, Head of Marketing at Viatris Korea, said, “We have improved patient convenience by launching not only Lipitor but also high-dose Lipitor and Lipitor Plus. We are planning various programs for dyslipidemia patients in Korea, and look forward to your continued interest."
- Company
- Possible reimb expansion for 2nd-gen BTK inhibitor Brukinsa
- by Eo, Yun-Ho Apr 25, 2024 05:50am
- BeiGene Korea The pharmaceutical industry is focusing on whether the second-generation BTK inhibitor 'Brukinsa' will overcome the last stage and acquire insurance reimbursement expansion. According to industry experts, BeiGene Korea is in negotiations with the National Health Insurance Service (NHIS) seeking approval for Brukinsa (zanubrutinib) in mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL) indications. If there are no expected delays in the negotiations, Brukinsa is set to be expanded for reimbursement in the first half of the year. The following indications for Brukinsa are included for expanding reimbursement: monotherapy treatment of adult patients with MCL who have received one or more prior therapy, monotherapy treatment of adult patients with CLL or SLL who have received one or more prior therapy, and treatment of patients with CLL or SLL who are either 65 years of age, or older or 65 years of age or younger with accompanying diseases and no prior therapy. Last May, Brukinsa was listed as a monotherapy drug for the treatment of adult patients with Waldenstrom macroglobulinemia (WM) who have had one or more prior therapy. Previously, BeiGene attempted to have Brukinsa listed for MCL, CLL, and CLL indications. However, the application was not approved by the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA). On their third attempt, the company progressed to the negotiation stage for drug pricing. Accordingly, the Korea Alliance of Patient Organization demanded an expansion of reimbursement for MCL and CLL indications for Brukinsa in a statement issued last year. Meanwhile, Brukinsa is a targeted anticancer agent that inhibits the survival and proliferation of malignant B cells by blocking Bruton's tyrosine kinase (BTK) protein, a signaling molecule that affects the survival and development of B cells. BTK inhibitors approved in South Korea are Janssen Korea’s 'Imbruvica (ibrutinib),' AstraZeneca Korea’s ' Calquence,' and Ono-Pharma Korea’s 'Velexbru (Tirabrutinib Hydrochloride).'
- Company
- 19 K-biosimilar products sold in 11 markets after 12 yrs
- by Chon, Seung-Hyun Apr 25, 2024 05:49am
- Domestic pharmaceutical and biotech companies have succeeded in commercializing biosimilars in 11 areas. In the 12 years since Celltrion's Remsima was introduced, 19 biosimilars have received domestic approval. Among the companies, Samsung Bioepis has entered 9 markets, the most among Korean companies. According to the Ministry of Food and Drug Safety, Samsung Bioepis received approval for Stelara’s biosimilar Epyztek on November 11. This is the first time Samsung Bioepis has received approval for a Stelara biosimilar in Korea. Stelara, which was developed by Janssen, inhibits the activity of interleukin (IL)-12/23, a type of inflammatory cytokine related to autoimmune diseases, and is used to treat plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Annual global sales of the drug amount to approximately KRW 14 trillion. Samsung Bioepis has successfully commercialized the first biosimilars in Korea in 3 areas this year. In January, Samsung Bioepis obtained marketing authorization from the MFDS for Episcli, a Soliris biosimilar. Soliris is a treatment for rare diseases such as paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome developed by Alexion, with global sales of approximately KRW 5 trillion. Also, the company obtained marketing authorization for Eylea biosimilar Afilivu in February. Eylea, which was developed by U.S.-based Regeneron, has indications for wet (neovascular) age-related macular degeneration. Macular degeneration is an ocular disease caused by aging and inflammation of the retinal macula, the nerve tissue in the center of the retina of the eye. In severe cases, it can cause blindness. With Samsung Bioepis succeeding in commercializing the first biosimilars in three markets in Korea this year, domestic pharmaceutical and biotech companies have now received approval for biosimilars in a total of 11 areas. Domestic companies first tapped into the biosimilar market in 2012 when Celltrion was granted approval for Remsima. Remsima is a biosimilar product of Remicade, an autoimmune disease treatment. Samsung Bioepis received MFDS approval for Remicade biosimilar Remaloce in 2015. Korean pharma and biotech companies have been receiving approval for their biosimilar products in the Enbrel, Humira, Herceptin, Mabthera, Avastin, Lucentis, and Nesp markets. In 2015, Samsung Bioepis received approval for its first biosimilar of Enbrel, Etoloce. In the Enbrel market, LG Chem received approval for the second Enbrel biosimilar, Eucept in 2018. Celltrion commercialized its second biosimilar, Herzuma, in 2014. Herzuma is a Herceptin. Herzuma was the first biosimilar of an anticancer drug that was released by a Korean company. Samsung Bioepis entered the Herzuma market second in 2017 with the approval of its Samfenet. In 2015, Celltrion received domestic approval for Truxima, a biosimilar of the anticancer drug Mabthera. A total of 3 domestically developed biosimilars have been approved in the autoimmune treatment Humira market. In July 2020, Samsung Bioepis received approval for Adalloce, the first Humira biosimilar, and Celltrion received approval for Yuflyma in June 2021. LG Chem received approval for Xelenka in December of last year, which became the third new entrant into the Humira market. Samsung Bioepis successfully commercialized its first biosimilar, Onbevzi, of the cancer drug Avastin in March 2021. Avastin is an anticancer drug indicated for the treatment of metastatic colorectal and metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer. In September 2022, Celltrion received domestic approval for the second Avastin biosimilar, Vegzelma. In 2022, 2 Lucentis biosimilars entered the domestic approval stage. Lucentis is used to treat eye diseases such as macular degeneration and diabetic macular edema. In May 2022, Samsung Bioepis received domestic approval for Amelivu, a biosimilar of Lucentis. In October of the same year, Chong Kun Dang obtained a domestic license for Lucentis biosimilar LucenBS. In 2018, Chong Kun Dang’s biosimilar Nesbell, a biosimilar of the anemia drug Nesp, reached the commercialization stage. In total, 19 biosimilars from Korean companies have been approved as of now. By company, Samsung Bioepis had the most biosimilars with 9, and Celltrion entered 6 markets. LG Chem and Chong Kun Dang each released 2 biosimilars.
- Product
- Will Prolia be able to continue on its high growth in KOR?
- by Moon, sung-ho Apr 24, 2024 05:45am
- The government will extend reimbursement for osteoporosis drugs, including Prolia (denosumab, Amgen). In particular, along with the reimbursement extension, the government has allowed switching between osteoporosis drugs. According to industry sources on the 20th, the Ministry of Health and Welfare recently issued an administrative notice of the ‘Details on the Standards and Methods for Applying Medical Benefits’ that outlined the contents above. Without special objections, the standards are expected to be in force from May. The main point of the amendment was to extend the reimbursement standard for major osteoporosis drugs used in the field. Specifically, the Ministry of Health and Welfare has decided to expand the criteria to allow borderline patients who have reached the T-score treatment goal to continue to receiving reimbursement for osteoporosis drugs. Patients who have been recognized as eligible for reimbursement for a T-score of -2.5 or less (T-score≤-2.5) when measuring bone mineral density using Dual-Energy X-ray Absorptiometry (DXA) of the central bone, will be eligible for an additional year of reimbursement if their T-score improves during treatment to a T-score greater than -2.5 but less than or equal to -2.0. If the T-score remains greater than -2.5 but less than or equal to -2.0 thereafter, reimbursement will be allowed for another year. In the additionally approved period, patients will be allowed to switch between raloxifene, bazedoxifene, bisphosphonate, and denosumab. The patients may also switch to zoledronic acid injections. The MOHW explained, "After referring to textbooks, guidelines, clinical papers, and academic society (expert) opinions, we decided to extend reimbursement to allow patients diagnosed with a T-score of -2.5 or less via DEXA to continue using the treatment if their T-score improves to -2.5 but less than or equal to -2.0." Meanwhile, the government's reimbursement extension for osteoporosis drugs sheds light on Prolia, which currently dominates the osteoporosis prescription drug market. Since this year, the MOHW has been scrutinizing osteoporosis drugs, known as selective focus review, due to the sharp rise in their claims. In essence, the government’s focus is on Prolia, among osteoporosis drugs. According to the drug research institution IQVIA, Prolia generated KRW 151.1 billion in prescription sales last year after posting KRW115.7 billion in 2022 in Korea. As a single product, it is second only to Keytruda (pembrolizumab), an immuno-oncology drug with unrivaled sales, in the domestic prescription market. The single drug’s sales in the domestic prescription market are comparable to those of mid-sized pharmaceutical companies Despite the government's scrutiny, Prolia's growth is expected to continue with the osteoporosis drug's reimbursement expansion and switching. An industry insider who requested anonymity said, "Last year, the top three items in terms of sales were Keytruda, Prolia, and Lipitor, and the sales of each exceeded the total sales of all mid-sized domestic pharmaceutical companies. Given the level of influence a single item can have on market trends, we need to consider reclassifying the threshold for blockbusters to drugs that post more than KRW 50 billion in annual sales.”
- Opinion
- [Reporter’s View] Decreased vaccine funding during endemic
- by Son, Hyung-Min Apr 24, 2024 05:44am
- K-bio and Vaccine Fund No.3 is soon to be launched. Considering the recent contraction of the investment market, the entire amount of KRW 40 billion of investment money from the government and the government-run bank has been invested, regardless of the formation size. Once the initial formation of KRW 70 billion is raised, early investment will be possible. In August 2022, the Ministry of Health and Welfare (MOHW) announced the establishment of the K-Bio and Vaccine Fund as part of the government’s policy commitments. The MOHW stated that it had invested KRW 50 billion and KRW 100 billion each in two funds, with additional investments of KRW 100 billion from the government-run banks (Korea Development Bank, Korea Eximbank, and Industrial Bank of Korea) and KRW 300 billion of private capital. These funds will be used to support companies that engage in vaccine development. However, the investment amount in the fund has gradually decreased. Few companies invest in funds due to a frozen private investment market. While the government raised KRW 261.6 billion through the K-Bio and Vaccine Funds No.1 and No.2, the investment size has now reduced to KRW 70 billion in No.3. In fact, this trend is not irrelevant to the end of the COVID-19 pandemic. In 2022, various Korean pharmaceutical and biotech companies like GC Biopharma, Ilyang Pharmaceutical, Genexine, and Shin Poong Pharm challenged the COVID-19 vaccine and treatment. However, with the shift of COVID-19 to the endemic phase, many of them either suspended clinical trials or withdrew development plans. With the waning interest from the government, the pharmaceutical and biotech industry, and citizens, the presence of the vaccine fund is now in question. The size of the vaccine fund is also raising concerns. Industry experts argue that an investment size of trillions of Korean won is necessary to develop new domestically developed drugs. However, the government reduced the fund’s size to KRW 1 trillion. Since the fund has not reached KRW 1 trillion, it is anticipated that Fund No.3 is expected to end with the formation of less than KRW 100 billion. When combining the sizes of Funds No.1, No.2, and No.3, the total is less than KRW 500 billion. In particular, the current fund size of KRW 300 billion is insufficient to support even late-phase clinical trials for a single pharmaceutical and biotech company. Many companies that develop new drugs domestically are abandoning development due to the high costs involved in phases 2 and 3. Most companies are unable to progress to phase 2 clinical trials. In the end, it may be difficult for President Yoon Suk Yeol to secure the vaccine and treatment technology to prepare for the Next Pandemic, as he has advocated since his inauguration. The vaccine fund is now non-commital due to the COVID-19 endemic and insufficient funds. There is a prevailing sentiment in the industry that instead of having high expectations for policies, the focus is on the government designating biotech as a promising industry and showing interest and support. Despite the heavy impact of the COVID-19 pandemic on Korean citizens, the government’s efforts to secure vaccines and treatment are waning with the announcement of the endemic. Doubts are emerging about whether the government plans to increase vaccine funds if infectious diseases like COVID-19 occur again. During this period, there are concerns regarding the course of government policies.
- Company
- Samsung Bioepis’ Stelara biosimilar is approved in Europe
- by Chon, Seung-Hyun Apr 24, 2024 05:44am
- Samsung Bioepis Samsung Bioepis announced on the 23rd that the European Commission (EC) granted marketing authorization for its Stelara biosimilar Pyzchiva. The final marketing authorization comes 2 months after Pyzchiva received a positive opinion for marketing authorization from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) in February. Pyzchiva’s original drug Stelara, which was developed by Janssen, is an autoimmune disease treatment for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It inhibits the activity of interleukin (IL)-12,23, a class of proinflammatory cytokines involved in the adaptive immune response. It posts annual global sales of approximately KRW 14 trillion. The company explained, “EC’s approval of Pyzchiva further extends our portfolio for autoimmune diseases by including an interleukin inhibitor to our existing 3 tumor necrosis factor-alpha (TNF-α) inhibitors - Benepali, Flixabi, and Imraldi.” Samsung Bioepis has currently 7 biosimilar products commercialized in the European market. The company has 7 biosimilar products in the European market. Samsung Bioepis currently sells biosimilars of Enbrel, Remicade, Humira, Herceptin, Avastin, Lucentis, and Soliris in the European market.” Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, said, "We are pleased to be able to receive European approval for our interleukin inhibitor Pyzchiva. We will continue to secure various autoimmune disease treatments and develop new drugs to provide patients with more treatment options."
