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- 2026-05-06 10:41:32
- Policy
- Subject drugs with claims over KRW 5 bil for price nego
- by Lee, Tak-Sun Jan 03, 2024 05:40am
- A study has shown that more drugs need to be subject to PVA negotiations due to the expanded scope of use. In other words, the current standard, which sets the expected additional claims amount in the KRW 10 billion range needs to be expanded to KRW 5 billion, and drugs with an expected increase rate of more than 100 % should also be subject to negotiations. Such results were disclosed as part of the 'Study on the Performance and Improvement of the Scope of Use Expansion Negotiation System' that was conducted as a research service for the National Health Insurance Service (Research Institute Yonsei University, Industry-Academia Cooperation Center, Professor Euna Han). The research team said, “The current system was introduced in 2014 and has been maintained for 10 years without any revision. With the continued rise in national health insurance’s drug expenditures and the increasing number of drugs with multiple indications, many of which are expensive RSA drugs, there is a clear need for revision of the system.” The research team said, "It is important to review the performance of the expanded use negotiation system, which proactively manages drug costs for expanded use of drugs, represented by expanded indications, and to prepare development plans to strengthen the capability of the system,” and suggested short- and long-term improvement measures. As a short-term improvement plan, the researchers first proposed that the criteria for the selection of negotiation targets need to be expanded from the current estimated additional claims amount of KRW 10 billion or more to an estimated additional claims amount of KRW 5 billion or more and to establish new criteria for selection of negotiation targets based on the estimated additional claims amount (e.g., an increase of 100% or more). Secondly, as a measure to improve the performance of the negotiation system, the researchers proposed that the reduction rate set through prior adjustments should be increased, which is considered one of the price criteria used during negotiation. In addition, the researchers also proposed differentiated drug price cuts based on the rate of increase in claims, not by just the additional claims amount. In the long term, the researchers proposed that drugs subject to focus management (e.g., drugs with annual claims of more than KRW 30 billion or annual expenditures of more than KRW 300 million per person) should be selected and be designated as mandatory negotiation targets when expanding their scope of use, regardless of the selection criteria. Second, although the current system that manages the expanded scope of use uses the period one year before and after the expansion of use as the reference period, considering that the amount of usage and claims for one year after the expansion may differ from the use amount and claims made in the mid-to-long-term. Therefore, the researchers requested the government to consider post-management measures such as financial impact assessment and drug price adjustment measures accordingly from the mid-to-long-term perspective. The researchers also suggested strengthening the linkage with the Price-Volume Agreement system in the short term to minimize the loss in the monitoring period arising from the expansion of the scope of use and in securing the sustainability of health insurance by strengthening reimbursement management.
- Company
- New antibiotic to be listed for reimb, following Zerbaxa
- by Eo, Yun-Ho Jan 03, 2024 05:40am
- Pfizer Pharmaceutical Korea is currently in negotiations for reimbursement pricing for its Zavicefta Inj (ceftazidime·avibactam). Zavicefta, the next-generation antibiotic, is progressing towards reimbursement listing. According to the industry, Pfizer Pharmaceutical Korea is currently in the final round of discussions with the National Health Insurance Service (NHIS) to settle the reimbursement pricing negotiations for its Zavicefta Inj (ceftazidime·avibactam). Zavicefta received approval from the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Committee in September 2023, and its negotiations began in November. When negotiations reach a settlement without any delays, it is anticipated that Zavicefta will be able to get listed for reimbursement next month. Until now, apart from MSD Korea’s Zerbaxa Inj (ceftazidime·tazobactam), new antibiotics have not produced satisfactory results. Therefore, it is noteworthy to watch whether Zavicefta will successfully receive reimbursement listing. Zavicefta has been developed in response to the urgent need for new antibiotics to treat serious infections that are becoming increasingly resistant, such as multi-drug resistant P. aeruginosa, carbapenem-resistant Gram-negative pathogens, and ESBL-producing Enterobacteriaceae. Zavicefta, an intravenous injection, is targeted for use in the treatment of adult patients suffering from complicated intra-abdominal infections (cIAI); complicated urinary tract infections (cUTI), including pyelonephritis; hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP); and, the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options. Zavicefta was initially developed by AstraZeneca and later became the property of Pfizer when Pfizer acquired AstraZeneca’s antibiotics business in 2016. Securing new alternative treatments for carbapenem-resistant Gram-negative pathogens is a global health priority, as announced by the WHO. Multi-drug resistant P. aeruginosa has seen a global increase and is causing serious problems in recent healthcare-related infections. The WHO has appointed carbapenem-resistant Gram-negative pathogens as one of the pathogens requiring high-priority research and development of new antibiotics. The rate of gram-negative pathogens exhibiting carbapenem resistance in Korea is 30.6%, ranking as the second highest among the countries surveyed, with Greece being the highest. ESBL-producing Enterobacteriaceae confers resistance to most cephalosporins-class antibiotics, which are typically effective against a broad range of gram-negative pathogens. To date, new antibiotics introduced in Korea include MSD’s Zerbaxa (ceftazidime·tazobactam) and Pfizer’s Cresemba (isavuconazonium), etc. Zavicefta has recently passed the Drug Committee (DC) of the “Big 5” hospitals, including Seoul National University Hospital, Samsung Seoul Hospital, Seoul St. Mary's Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. It has secured prescription in approximately 40 hospitals in Korea.
- Company
- ‘Drug pricing and reimb' needs most regulatory improvement
- by Chon, Seung-Hyun Jan 03, 2024 05:40am
- CEOs of both domestic and multinational pharmaceutical companies alike identified 'drug prices and reimbursement as in need of most regulatory improvement. CEOs of multinational pharmaceutical companies only gave a 2-point range satisfaction score in terms of satisfaction with Korea’s drug pricing and reimbursement regulations. This indicates how CEOs are even more dissatisfied with regulations that affect the management of pharmaceutical companies, such as new drug registration, generic reevaluation, and reimbursement reevaluations. According to Dailypharm's survey of 53 CEOs of pharmaceutical companies, CEOs of both domestic and multinational pharmaceutical companies had a negative perception of government regulations. Among the 42 CEOs of domestic pharmaceutical companies, 34% said that their attitude towards government regulations was negative, which is three higher than the 10% who said they had a positive attitude. More than half of domestic pharma CEOs described government regulation as ‘moderate.’ CEOs of multinational pharmaceutical companies were even more towards government regulations. Of the 11 multinational pharmaceutical company CEOs, 73% had a negative view of government regulation. "Very negative" and "negative" responses accounted for 18% and 55%, respectively. Not one respondent had a positive view of government regulation. The area with the most common complaints was drug pricing and reimbursement.’. When asked to name the most unreasonable regulations, 57% of respondents cited reimbursement and drug pricing. This means that three out of five pharma CEOs perceive reimbursement and drug pricing regulations as the most unreasonable. 25% of respondents cited licensing, production, and quality control as having the most unreasonable regulations. Only 11% said distribution, sales, and marketing regulations were the most unreasonable. Both domestic and multinational pharma CEOs were most dissatisfied with drug price and reimbursement regulations. Nearly half, 48%, of the 42 CEOs from domestic pharmaceutical companies said that reimbursement and drug pricing regulations were the most unreasonable. Licensing, production, and quality control followed at 29%. More than 10 out of 11 (90%) multinational pharma CEOs perceived that the drug pricing and reimbursement system was unreasonable. It is noteworthy that the multinational pharmaceutical companies, which are responsible for a sizable proportion of new drug listing and sales, are most dissatisfied with drug pricing and reimbursement listing regulations in place for market entry. The dissatisfaction with the drug pricing and reimbursement system among MNCs was also evident in the specific indicators. CEOs of multinational pharmaceutical companies gave a satisfaction score of 2.90 points for Korea’s drug pricing and reimbursement system. This is significantly lower than the 3.24 score given by domestic pharmaceutical CEOs. 73% of multinational pharma CEOs said that new drug approval is in need of the most urgent improvement. Even if a new drug is developed and approved by company headquarters after a long period of research and development (R&D), there are many cases where their launch is delayed or abandoned in Korea due to inadequate drug prices or reimbursement. CEOs of domestic pharmaceutical companies perceived post-generic drug price reductions as the most problematic. Last year, the government lowered the prices of more than 7,000 drugs through generic drug price reevaluations, and the industry complained that repeated generic drug price reductions due to system changes threaten business. CEOs of domestic pharmaceutical companies also pointed out the need to improve reimbursement reevaluations (21%) and price-volume agreement systems (18%).
- Policy
- 430K osteoporotic fractures in 2022, a steep rise over 20 yr
- by Lee, Tak-Sun Jan 02, 2024 05:45am
- There has been a yearly increment of 7.8% in patients with fractures due to osteoporosis, marking a staggering 346% increase compared to 20 years ago. Joint research conducted by National Health Insurance Service (NHIS) (Chariman: Jung Ki Suck) and The Korean Society for Bone and Mineral Research (Chariman: Ha Yong-Chan) has presented research findings titled ‘Reporting the incidences of osteoporotic fractures and re-fractures among Koreans over 50 years old,’ based on the National Health Insurance Big Data for the periods of 2002 to 2022. The overall incidence of osteoporotic fracture totaled 434,470 patients in 2022, a 34.2% increase compared to 323,806 patients in 2012, and a 346.2% increase compared to 97,380 patients in 2002. Additionally, it shows a yearly increment of 7.8%. Over the last 20 years, the overall incidence of osteoporotic fractures has steadily increased, with a yearly average rate of 8.1% increase in men and a 7.6% increase in women. A yearly rate of osteoporotic fracture incidences based on the National Health Insurance Big Data for the periods of 2002 to 2022. There has been a yearly increment of 7.8% in patients with fractures due to osteoporosis, marking a staggering 346% increase compared to 20 years ago. When considering gender differences, the prevalence of fracture was 3.1 times higher in women (329,104 people) than men (105,366 people). Among men, 29.1% were in their 60s, while 33.1% of women were in their 80s. (Unit: n, %) As of 2022, out of a total of 434,470 fracture patients, 31.0% were in their 80s (134,549), 26.3% were in their 70s (114,273), 26.4% were in their 60s (114,886), and 16.3% were in their 50s (70,762), demonstrating a steep increase with advancing age. When considering gender differences, the prevalence of fracture was 3.1 times higher in women (329,104 people) than men (105,366 people). Among men, 29.1% were in their 60s, while 33.1% of women were in their 80s. Wrist and ankle fractures were common in the ages of 50s to 60s, and the number of vertebral and hip joint fractures increased with age. The 1-year mortality rate for patients with hip joint fractures exhibited a decreasing trend from 18.9% in 2006 to 15.9% in 2020 but increased again to 18.2% in 2021. In contrast, the 1-year mortality rates of hip fracture or vertebral fracture remained without any changes over the years up to 2020, but saw an increase in 2021, presumably due to the effects of Covid-19. During the last 20 years, the rate of osteoporotic fracture patients receiving osteoporosis-treating medications within a month is 22.0% in 1 month, 28.9% in 3 months, 32.2% in 6 months, and 35.5% within a year. In terms of medications, the highest prescription rate within a year following a fracture was for bisphosphonate class drugs 30.8%, followed by denosumab 3.3%, Selective estrogen-receptor (ER) modulators (SERMs) 2.9%, parathyroid hormones (PTH) 0.7%, and romosozumab 0.15%. The prescription rate for fracture treatments within a year following a fracture showed a steady increase for both men and women over the years. A 2.5 times higher proportion of women, with a rate of 46.9%, started treatments within a year compared to men, with a rate of 18.7%. In terms of fracture localizations, the highest prescription rate within a year following a fracture was the vertebral fracture with 52%, and the lowest was the ankle fracture with 15%.
- Policy
- 5-year relative survival rate of cancer 72.1% in 2021
- by Lee, Jeong-Hwan Jan 02, 2024 05:45am
- The five-year relative survival rate for cancer patients increased by 6.6% points in 10 years and has become 72.1%. In Korea, thyroid cancer was the most common, followed by colorectal, lung, and stomach cancers. On December 28th, the Ministry of Health and Welfare (Minister Kyoo-Hong Cho) and the Central Cancer Registry Cancer (National Cancer Center, Director Hong-Gwan Seo) released the 2021 National Cancer Registry statistics (cancer incidence, relative survival rate, prevalence, etc.). The number of new cancer cases in 2021 was 277,523, an increase of 27,002 (10.8%) compared to 2020. This is analyzed to be a result of a resurgence in the use of healthcare services, including cancer screenings, which had decreased due to the COVID-19 pandemic, and an expansion of the scope of registration screening subjects made according to changes in cancer registration guidelines. The most common cancer in 2021 was thyroid cancer (35,303, up 19.1% from 2020), followed by colorectal, lung, stomach, breast, prostate, and liver cancers. The incidence of stomach, colorectal, liver, and cervical cancers, which are cancer types targeted by the National Cancer Screening Program, has been decreasing for the past decade, while the incidence of breast cancer has been increasing for the past 20 years. The 5-year relative survival rate for cancer patients diagnosed in the last 5 years ('17-'21) was 72.1%, indicating that 7 out of 10 cancer patients survived for more than 5 years. The 5-year relative survival rate for cancer patients has continued to increase and is 6.6% points higher than the rate found for cancer patients who were diagnosed around 10 years ago (’06-’10, 65.5%). As of January 1, 2022, 2,434,089 people had cancer. 1 out of every 21 people (4.7% of the total population) had cancer, and 1 out of every 7 people aged 65 and older (1,194,156 cancer patients) had cancer. In particular, as of 2021, more than half (60.8%) of people with cancer survived for more than 5 years after being diagnosed, amounting to 1,795,366, which is an increase of 111,396 survivors compared to the previous year (1,361,840 survivors).
- Company
- SK Chemicals ends copromotion agreement with Eli Lilly
- by Lee, Tak-Sun Jan 02, 2024 05:45am
- SK Chemicals announced that its copromotion agreement with Lilly Korea for the antidepressant Cymbalta Cap (duloxetine hydrochloride) and the migraine treatment Emgality (galcanezumab-gnlm) has been brought to an end. Cymbalta is the number one selling antidepressant on the market. Sales of Emgality have also been rising since last year's reimbursement approval. SK Chemicals has co-marketed Cymbalta since 2017 and Emgality since July 2020 with Lilly. According to industry sources, SK Chemicals will supply Cymbalta until Dec. 31 last year and Emgality until Jan. 31 this year with the termination of the co-promotion agreement with Lilly Korea. Cymbalta is the No. 1 antidepressant in Korea's KRW 30 billion antidepressant market, with sales of KRW 9.7 billion last year, according to IQVIA. It is mainly prescribed for depression but is also used to treat diabetic peripheral neuropathic pain, fibromyalgia, and osteoarthritis pain that has not responded adequately to non-steroidal anti-inflammatory drugs. SK Chemicals has been responsible for marketing and sales activities for Cymbalta's pain-related indications since January 2017. The announcement this time marks the end of the co-promotion agreement in 5 years. Emgality, a migraine prevention drug, has been co-marketed by the companies since July 2020. SK Chemicals had been in charge of marketing the drug in domestic clinics, and the two companies worked together on marketing it in general hospitals. Emgality is the first drug to be introduced in Korea to prevent migraines and offers convenience as a once-a-month subcutaneous injection therapy. Emgality has been listed for reimbursement since September last year, and sales have been on the rise ever since The drug, which generated sales of KRW 5.7 billion last year, has posted sales of KRW 3 billion in the first half of the previous year alone, according to IQVIA.
- Company
- CMV treatment Livtencity lands in Big 5 hospitals in KOR
- by Eo, Yun-Ho Jan 02, 2024 05:45am
- Takeda Pharmaceuticals Korea’s Livtencity (maribavir) has recently passed the Drug Committee (DC) of the “Big 5” hospitals. Livtencity, a cytomegalovirus (CMV) treatment, is nearing prescription at tertiary general hospitals. According to industry sources, Takeda Pharmaceuticals Korea’s Livtencity (maribavir) has recently passed the Drug Committee (DC) of the “Big 5” hospitals, including Seoul National University Hospital, Samsung Seoul Hospital, Seoul St. Mary's Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. Takeda Pharmaceuticals Korea submitted its reimbursement application for Livtencity in Q3 of 2022 and successfully cleared the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Committee in October of the same year. Currently, negotiations for Livtencity’s drug pricing are ongoing, and its subsequent listing for reimbursement is anticipated to lead to immediate prescriptions. CMV is a type of herpesvirus that 60% of adult populations globally are infected with at least once in a lifetime. CMV is one of the common diseases that occur in Hematopoietic Stem Cell Transplantation (HSCT) patients during the time of immunosuppression. The development of CMV remain critical complications, with 30%-70% of HSCT recipients experiencing CMV viral infections. In HSCT recipients, CMV infections can result in multi-organ dysfunctions, such as pneumonia, hepatitis, gastroenteritis, retinitis, and encephalitis. Among these, the mortality of patients with pneumonia is approximately 60%. CMV development in immunocompromised patients can be fatal. Therefore, the patients typically received first-line treatments and were prescribed medications such as ganciclovir, valganciclovir, foscarnet, and cidofovir. In most cases, hospitalization was necessary. Additionally, the mechanism of action of these treatments is similar, so when patients develop tolerance to one treatment, it is highly likely that they may not respond well to other treatments. Livtencity may offer patients hope for second-line treatment options. Compared to existing treatments, Livtencity has fewer side-effects and can serve as an alternative treatment option when patients develop tolerance to existing treatments. The antiviral activity of Livtencity, through its novel multimodal mechanism of action, works by inhibiting HCMV-specific UL97 Protein Kinase, thereby inhibiting CMV replication and transport. Its effect is not limited to inhibiting DNA from exiting the cell; it also inhibits DNA replication and viral encapsulation. Livtencity received approval from the U.S. FDA in November 2021 as the first treatment for patients with CMV infection and subsequently received approval in Korea in December 2023.
- Policy
- Revising the PE exemption system… focuses on 'deferral'
- by Lee, Tak-Sun Jan 02, 2024 05:44am
- The ‘Pharmacoeconomic Evaluation Exemption System', which was first implemented in 2015, will be completely transformed in the new year. In the future, the system will defer rather than exempt companies from submitting required data, increasing the possibility of drugs being evaluated after listing. According to the industry on December 29th, the study on 'Preparation of a plan to improve the pharmacoeconomic evaluation data submission waiver system’ that was conducted as the Health Insurance Review and Assessment Service’s research service in February, has been completed. The results of the study, which mention the need to redesign the system to defer data submission rather than omit it, are expected to be used to make systemic improvements. As a result, drugs subject to deferral of pharmacoeconomic evaluation data submission will also prepare evidence for the agreements it had made when it was listed through prior assessments. The system, which was implemented in 2015, is applied to rare disease drugs and anticancer drugs for which no alternatives exist. This year, it was also applied to pediatric drugs that have proven to improve quality of life. However, the HIRA believes that these drugs need to undergo a post-marketing cost-effectiveness evaluation, given how expensive these drugs are. The need for post-marketing evaluation of PE exemption drugs was also mentioned at the public hearing for the ‘Performance-based reimbursement management plan for drugs using RWD/RWE’ that was held last November. At the time, Mi-Young Yoo, Director-General of the Pharmaceutical Benefits at HIRA, said, “Since the introduction of the positive listing system in 2006, many drugs have been listed for reimbursement through various systems including the PE exemption system to enable better patient access. So this is now the time a post-listing measure needs to be implemented. Although social consensus should be made on its need, such a management system can be a way to ensure an appropriate level of financial soundness within limited insurance.” This implied that RWD (Real-World Data) can be used to post-evaluate drugs that have omitted pharmacoeconomic evaluations. At the ‘2023 Korean Association of Health Technology Assessment Winter Conference' that was held on the 1st of the previous month, experts raised voices that the system should be redesigned so that the exemptions are switched to deferrals. Accordingly, HIRA is expected to improve the overall system to introduce post-evaluation of PE exemption drugs this year, based on the results of the research service.
- Company
- Celltrion merges and launches with founder’s son as leader
- by Kim, Jin-Gu Dec 29, 2023 05:40am
- Celltrion’s Chair of the Board, Jin-Seok Seo, the eldest son of Celltrion’s Chairman Emeritus Jung-jin Seo, will helm the newly merged Celltrion. The new CEO Seo will lead the company in a 3-person representative system with Hyung-Ki Kim, current CEO of Celltrion, and Hyung-Ki Kim, former CEO of Celltrion Healthcare. Celltrion announced on the 28th through a resolution of its board of directors that it has completed the merger with Celltrion Healthcare and will be rebranded as a unified Celltrion. At the meeting, the board also approved the appointment of three new Vice-chairs: Woo-Sung Kee, Vice Chairman of the Manufacturing & Development Division (currently CEO of Celltrion), Hyung-Ki Kim Vice Chairman of the Global Sales Division (former CEO of Celltrion Healthcare), and Jin-Seok Seo, Chairman of the Management Division (currently Chairman of Celltrion's Board of Directors). Celltrion expects that the three-person representative system will enable faster decision-making and accelerated growth of the newly merged Celltrion. (from the left) Representatives Woo-Sung Kee, Hyung-Ki Kim, and Jin-Seok Seo, Celltrion expects the combined entity to consolidate assets that were previously spread across the two companies and leverage significant resources. The new company will invest more aggressively in securing new growth engines such as biosimilar and new drug pipeline development, in-licensing, mergers and acquisitions (M&A), and digital healthcare. In addition, the company expects to gradually reduce its cost of sales to 40% from the current level of 70% through business structure consolidation. In particular, the company plans to expand its entry into major global markets rapidly increase sales, and expand the market share of its drugs based on the lower cost rate. Currently, Celltrion has successfully commercialized 6 products – Remsima, Herzuma, Truxima, Vegzelma, Yuflyma, and Remsima SC (Zympentra). Celltrion's strategy is to secure an 11-product lineup by 2025 and a total portfolio of 22 products by 2030. In the case of Zympentra (the U.S. brand name for Remsima SC), which is expected to be launched as a new drug in the U.S. next February, is expected to become the flagship product of the integrated Celltrion. The U.S. TNF-α inhibitor market, which includes infliximab, is the world's largest at $47.36 billion (KRW 62.570 trillion) as of last year, and the inflammatory bowel disease (IBD) market, which Zympentra seeks to target first, is said to be worth about $9.827 billion (KRW 12.8 trillion). Starting with Zympentra, Celltrion aims to generate 40% of its future sales from new drugs through a portfolio of promising new drugs including antibody-drug conjugates (ADCs), bispecific antibodies, and microbiomes. For this, the company explained that it is focusing on securing a new drug pipeline through in-house development as well as collaboration with various domestic and foreign companies. In addition, it plans to develop customized disease prevention and management solutions using clinical and genomic data it acquired over the years, and actively expand its business to the field of digital healthcare.
- Company
- K-similars set out to enter the global market
- by Son, Hyung-Min Dec 29, 2023 05:40am
- Domestic companies are now ready to launch homegrown biosimilars into the global market next year. According to industry sources on the 28th, Celltrion, Samsung Bioepis, and Dong-A ST have completed Phase III clinical trials of its biosimilars and applied for approval from overseas regulators. The companies have successfully developed biosimilars for their global blockbusters such as Stelara and Prolia and are seeking approval next year. Celltrion expects to receive approval for 3 biosimilars next year Celltrion has the largest biosimilar pipeline among domestic companies. To date, the company has 12 pipelines, with six products on the market that include the COVID-19 drug Regkirona, and four more that completed Phase III trials and are on track for marketing authorizations. Celltrion's products that are expected to be approved next year are its Prolia biosimilar CT-P41, Xolair biosimilar CT-P39, Stellara biosimilar CT-P43, and Eylea biosimilar CT-P42. In Phase III trials, the four candidates demonstrated non-inferiority to their respective original drugs. Based on the global Phase III results of CT-P41 this month, Celltrion filed for marketing authorization of CT-P41 for all of Prolia's U.S. indications. Prolia is an Amgen-developed osteoporosis treatment with multiple indications, including giant cell tumor of bone and bone loss. After the U.S., Celltrion plans to file for approval in other key global markets, including Europe. This month, Celltrion also completed the filing of a marketing authorization application for CT-P39 in Canada. The original CT-P39 product, Xolair, is an antibody biologic developed by Novartis for the treatment of allergic asthma, chronic rhinosinusitis with nasal polyposis, and chronic spontaneous urticaria. Xolair is a blockbuster product that generated approximately $5 trillion in global sales last year. Celltrion is also nearing commercialization of its Stelara biosimilar CT-P43. To date, it has filed for approval in the U.S., Europe, South Korea, and Australia. Stelara is an interleukin (IL)-12 and 23 inhibitor developed by Johnson & Johnson’s subsidiary Janssen and is used to treat autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The global Stelara market was valued at approximately $23 trillion last year. Celltrion finalized an agreement with Johnson & Johnson last year that will allow the drug to be sold in the US starting Feb. 22 next year. Celltrion also recently completed a Phase III clinical trial for its Eylea biosimilar CT-P42 and recently filed for its marketing authorization in the U.S. and Europe. Ayla is a blockbuster macular degeneration treatment developed by Bayer and Regeneron that generated approximately $12 trillion in global sales last year. With such a diverse pipeline, Celltrion aims to have a portfolio of 22 biosimilars by 2030. Samsung Bioepis nears approval of its Prolia biosimilar next year Samsung Bioepis has successfully commercialized five biosimilars in overseas markets in collaboration with its global marketing partners Biogen and Organon. Its candidate that is closest to approval next year is SB16, a Prolia biosimilar. In a Phase III clinical trial conducted on postmenopausal osteoporosis patients, SB16 demonstrated equivalent efficacy to the original drug in terms of change from baseline in lumbar spine and bone mineral density at 12 months after administration. Also, Samsung Bioepis has completed clinical trials of SB15, its Eylea biosimilar, and is pursuing approval procedures in the U.S. and Europe. Samsung Bioepis conducted a Phase III clinical trial involving 449 patients with wet age-related macular degeneration (nAMD) in 10 countries, including the United States and Korea. In the trial, Samsung Bioepis evaluated patients' best-corrected visual acuity (BCVA) up to 56 weeks of treatment with SB15 and found comparable BCVA improvements compared to the original drug. Samsung Bioepis plans to accelerate its expansion in the European market by emphasizing that its biosimilar, SB15, is interchangeable with the original drug. In addition, in May last year, Samsung Bioepis obtained domestic marketing authorization for Lucentis' biosimilar Amelivu, which was approved in the U.S. and Europe in the second half of 2021. Lucentis, a macular degeneration treatment developed by Novartis, is a blockbuster drug that generated global sales of around KRW 4 trillion in 2020. Dong-A ST and Sam Chung Dang Pharm enters the biosimilar competition…submits an application to regulatory authorities Dong-A ST’s Stellara biosimilar DBM-3115 is expected to be approved in Europe next year. The company completed submitting its application to the European Medicines Agency (EMA) in June after demonstrating therapeutic equivalence between its DBM-3115 and Stellara in a global Phase III trial. The company is also preparing for U.S. approval next year. Last month, Sam Chun Dang Pharmaceutical applied for domestic approval for both vials and prefilled syringe formulations of its Eylea biosimilar candidate SCD411. Sam Chun Dang is also preparing for its approval in the United States and Europe. The application was made based on the results of the global Phase III clinical trial on SCD411. In a clinical trial involving 576 patients with macular degeneration, SCD411 demonstrated equivalence to Eylea. In addition, Huon's Global subsidiary, Huons Lab, is also accelerating the development of its Prolia biosimilar, HLB3-013. In February, the company announced that it had confirmed equivalence in nonclinical animal efficacy studies compared to the original product.
