Israel-based pharmaceutical company Teva Pharmaceutical Industries Ltd (NYSE:TEVA) (TASE:TEVA) on Tuesday announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted applications for TVB-009P, a biosimilar candidate to Prolia (denosumab).

Both applications include all indications approved for Prolia, including conditions with a high risk for fracture such as osteoporosis in postmenopausal women. The FDA and EMA are expected to make decisions in the second half of 2025.

TVB-009P is the first internally developed biosimilar from Teva to be submitted to the FDA. The submissions are supported by a comprehensive data package, including results from Phase 3 clinical trials and pharmacokinetic studies.

Osteoporosis affects millions of women worldwide, increasing their risk of bone fractures. Teva's biosimilar candidate, if approved, could offer a new treatment option for patients with this condition.