Celltrion secures FDA approval for Stoboclo, Osenvelt biosimilars

The U.S. Food and Drug Administration (FDA) has approved Celltrion's biosimilars Stoboclo and Osenvelt, which reference Amgen's Prolia and Xgeva, respectively. Both drugs have been approved for multiple indications, including treatment for postmenopausal osteoporosis and prevention of skeletal-related complications in cancer patients. The approvals are based on clinical evidence showing no significant differences in efficacy and safety compared to the original products. Celltrion plans to launch these biosimilars in the U.S. by June 2025, following a patent settlement with Amgen. This approval expands Celltrion's portfolio, which aims to grow to 22 biosimilars by 2030. The global market for Prolia and Xgeva was valued at approximately $6.6 billion last year, with a significant portion attributed to U.S. sales.