TEVA applications for Prolia biosimilar accepted by FDA, EMA

Teva Pharmaceutical Industries (NYSE:TEVA) said its market applications have been accepted for review by the FDA and European Medicines Agency for its proposed biosimilar of the osteoporosis drug Prolia, also known as denosumab.

Decisions by both agencies are expected in the second half of 2025, according to a statement.

Denosumab is marketed under the brand name Prolia by Amgen (AMGN), which developed the drug.