On April 2, 2025, Accord received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for two denosumab biosimilars: OSVYRTI and JUBEREQ. OSVYRTI is indicated for the treatment of certain types of osteoporosis and bone loss. JUBEREQ is indicated for the prevention of certain skeletal events (e.g. pathological fractures) in adults with advanced bone malignancies as well as for the treatment of certain giant cell bone tumors. Once marketing authorization is granted, this would be Accord’s sixth biosimilar molecule approved for marketing in Europe. Accord has said that it plans to launch its denosumab biosimilars after the expiration of patents covering Amgen’s denosumab products, PROLIA and XGEVA, in November 2025.
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