08:21 AM EDT, 10/08/2024 (MT Newswires) -- Teva Pharmaceutical (TEVA) said Tuesday it has received the US Food and Drug Administration's acceptance and the European Medicines Agency's validation for its applications of TVB-009P, a biosimilar candidate to Prolia to treat osteoporosis in postmenopausal women.

The company anticipates the FDA's expected decision and EMA's expected opinion in H2 next year, Teva added.

TVB-009P is the first of the firm's internally developed biosimilars to be submitted in the US, the company said.

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