On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Amgen’s PROLIA® (denosumab) that treats osteoporosis. Both applications include all indications approved for PROLIA®, including conditions with a high risk for fracture, such as osteoporosis in postmenopausal women.
TVB-009P is the first of Teva’s internally developed biosimilars to be submitted to the FDA; Teva is seeking FDA approval that its denosumab biosimilar is interchangeable with PROLIA®. Teva anticipates that the FDA’s decision and EMA’s opinion will come out in the second half of 2025. According to Steffen Nock, PhD, Head of Biosimilars and Chief Scientific Officer at Teva, “The filing acceptance and validation of TVB-009P, our proposed biosimilar to Prolia, underscores Teva’s commitment to broadening global access to biosimilars in both regions.”