Latest news with #Avtozma
Korea Herald
13-03-2025
- Business
- Korea Herald
Celltrion launches autoimmune disease treatment in US
Celltrion Inc., a major South Korean biopharmaceutical firm, said Thursday it has launched its biosimilar product for Stelara, an autoimmune disease treatment, in the United States. Steqeyma, a treatment for plaque psoriasis, Crohn's disease, active psoriatic arthritis and ulcerative colitis, is Celltrion's seventh biosimilar product that has hit the US market, the company said in a press release. The US Food and Drug Administration approved the biosimilar drug in both intravenous and subcutaneous formulations in December, it said. Celltrion has been making efforts to expand its presence in the US biosimilar market. In recent months, it has obtained FDA approval for the US sale of several biosimilars, including Avtozma, an autoimmune disease biosimilar to Actemra, as well as Stoboclo and Osenvelt, biosimilar drugs to Prolia and Xgeva. The global market for Stelara is estimated at US$10.36 billion, with the US accounting for two-thirds of global sales. Celltrion aims to commercialize 22 biosimilar products in global markets by 2030. (Yonhap)
Korea Herald
24-02-2025
- Business
- Korea Herald
Celltrion's Avtozma receives European marketing approval
South Korean pharmaceutical firm Celltrion announced Monday that Avtozma, a biosimilar of Actemra, has received approval from the European Commission. The approval covers major indications of the original drug, including rheumatoid arthritis and giant cell arteritis. Avtozma, an interleukin inhibitor, reduces inflammation by targeting the IL-6 protein. With this approval, Celltrion expands its autoimmune disease treatment portfolio beyond tumor necrosis factor-alpha inhibitors, broadening the scope of treatable patients. The biosimilar is the last of four product approvals in Europe this month, following Eydenzelt (Eylea biosimilar), Osenbelt and Stovoclo (Prolia-Xgeva biosimilar). These additions complete Celltrion's 11-product portfolio in Europe, a milestone already achieved domestically in December 2024. Celltrion's total market value for the 11 products is approximately 150 trillion won ($105.2 billion), covering treatments for autoimmune diseases, cancer, allergies, ophthalmology and bone disorders. The company aims to strengthen its position in the fast-growing autoimmune market while expanding into other therapeutic areas. "With consecutive product approvals in Europe, one of our key markets, we have successfully achieved our 2025 goal of establishing an 11-product portfolio. This also reaffirms our capabilities in pharmaceutical development,' a Celltrion representative stated. 'We will now focus on commercialization to drive global expansion and accelerate growth.'
Korea Herald
24-02-2025
- Business
- Korea Herald
Celltrion's autoimmune disease treatment gets approval in Europe
Celltrion Inc., a major South Korean biopharmaceutical firm, said Monday its new biosimilar for an autoimmune disease treatment has obtained approval from the European Commission. The EC approved Celltrion's Avtozma, a biosimilar to Actemra, in both intravenous and subcutaneous formulations, for sales in the member countries of the European Union, the company said in a press release. Avtozma can be used as a treatment for multiple autoimmune diseases, including rheumatoid arthritis and giant cell arteritis. "The EC approval on Avtozma marks a critical step in Celltrion's mission to provide European healthcare systems with affordable, effective solutions for immunological disorders," Ha Tae-hun, senior vice president in charge of Celltrion's European operations, said in the release. Avtozma was also approved by the US Food and Drug Administration for local sales last month. The Korean drugmaker aims to commercialize 22 biosimilar products by 2030, up from the current 11. (Yonhap)
Korea Herald
31-01-2025
- Business
- Korea Herald
Celltrion secures FDA nod for Actemra biosimilar Avtozma
Celltrion announced on Friday that its biosimilar Avtozma, a version of the autoimmune disease treatment Actemra (active ingredient tocilizumab), has received product approval from the US Food and Drug Administration. Based on the results of its global Phase 3 clinical trial, Celltrion applied for Avtozma's FDA approval last year. The approval covers major indications, including rheumatoid arthritis, giant cell arteritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis and COVID-19 infection. The original drug, Actemra, is available in two formulations: subcutaneous injection and intravenous injection. Celltrion has secured FDA approval for Avtozma in both formulations, allowing healthcare providers to prescribe the most suitable option based on patient needs. Actemra is an interleukin-6 inhibitor that works by suppressing the IL-6 protein, which is involved in inflammation, thereby reducing inflammation in the body. In 2023, the drug recorded global sales of some 2.63 billion Swiss francs ($2.89 billion). In the US market alone, Actemra generated $1.638 billion in revenue, accounting for more than half of its global sales, making the US the most significant market. Prior to US approval, Celltrion became the first company in Korea to obtain domestic approval for Avtozma last month, establishing itself as a first mover in the Actemra biosimilar market. Additionally, the company recently received a positive opinion for approval from the Committee for Medicinal Products for Human Use under the European Medicines Agency, moving a step closer to final authorization in Europe. With the FDA approval, Celltrion plans to establish a stable supply chain in the US and expand its market share through competitive pricing strategies and high-quality products. Avtozma is expected to offer an economical treatment alternative while maintaining efficacy and safety equivalent to the original drug, ultimately benefiting both patients and healthcare providers in the US. "Receiving FDA approval in the world's largest pharmaceutical market allows us to swiftly complete the remaining commercialization process and fully launch our strategy to penetrate the global autoimmune disease treatment market," a Celltrion official said. "We are committed to ensuring a faster and more stable supply of treatments for patients." With Avtozma's winning of domestic approval, Celltrion has achieved its goal to build an 11-biosimilar product lineup earlier than the initially planned target of the end of 2025. The drugmaker aims to expand its biosimilar portfolio to 22 products by 2030.
Korea Herald
31-01-2025
- Business
- Korea Herald
Celltrion gets US FDA approval for new biosimilar for autoimmune disease treatment
Celltrion Inc., a major South Korean biopharmaceutical firm, said Friday its new biosimilar for an autoimmune disease treatment has received approval from the US Food and Drug Administration. The FDA approved Celltrion's Avtozma, a biosimilar to Actemra, in both intravenous and subcutaneous formulations, according to the company. Avtozma can be used as a treatment for multiple autoimmune diseases, including rheumatoid arthritis and giant cell arteritis, as well as COVID-19. "This approval represents a strategic addition to our immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and healthcare providers," Thomas Nusbickel, chief commercial officer at Celltrion's branch in the US, said in a press release. Celltrion said Avtozma has great sales potential, noting its original drug, Actemra, raised 2.63 billion Swiss francs ($2.89 billion) globally in 2023. The Korean drugmaker has vowed to commercialize 22 biosimilar products by 2030. (Yonhap)
