Teva Prolia® (Denosumab) Biosimilar Candidate is Accepted for Review by U.S. FDA and EU EMA
TEVA(TEVA) GlobeNewswire News Room·2024-10-08 19:00
Prolia® (denosumab) is indicated to treat certain conditions that lead to high risk for fracture, including osteoporosis in postmenopausal women TVB-009P, Teva's proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of Teva's robust biosimilar portfolio – 7 approved biosimilars and 16 in the pipeline – across critical therapeutic areas such as oncology, immunology and respiratory medicine Anticipated decision by both agencies is expected in 2H 2025 TEL AVIV, Israel, Oct. ...