Latest news with #Eydenzelt
Korea Herald
10-04-2025
- Business
- Korea Herald
Celltrion wins 3 biosimilar approvals in Australia, eyes Oceania growth
South Korea's pharmaceutical giant Celltrion said Thursday it has received regulatory approvals for three biosimilars in Australia over the past two weeks, a move expected to amplify its presence in the Oceania market. According to the biosimilar maker, the approvals from Australia's Therapeutic Goods Administration cover eye treatment Eydenzelt, its version of Regeneron Pharmaceuticals' Eylea, as well as two bone-related therapies Stoboclo and Osenvelt, referencing Amgen's Prolia and Xgeva, respectively. With the newest additions, Celltrion now has 11 products either approved or marketed in Australia. 'Australia's biosimilar-friendly environment continues to spur our growth momentum,' a company official said. 'We aim to complete the remaining commercialization steps swiftly to ensure stable supply in the market.' Eydenzelt, available in both vial and prefilled syringe forms, has been approved for the treatment of myopic choroidal neovascularization, or CNV, making it the first biosimilar in its category to gain approval in Australia. Its reference product, Eylea, generated $9.52 billion in global sales last year, underlining strong market potential, the company noted. Stoboclo and Osenvelt were approved for all indications held by their reference biologics in Australia. Stoboclo is indicated for postmenopausal osteoporosis, while Osenvelt is approved for preventing skeletal-related events in cancer patients with bone metastases and for treating giant cell tumors of bone. Their originator drugs Prolia and Xgeva recorded a combined $6.59 billion in global sales last year. The company said the approvals mark a key milestone in expanding its global reach, including in the Oceania region, with additional plans to broaden its pipeline in ophthalmology and bone-related therapies.
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.'
