Teva Reports the US FDA Approval of Degevma (Biosimilar, Xgeva)

Shots: The US FDA has approved Degevma, a biosimilar version of Xgeva (denosumab), following FDA approval of Ponlimsi (biosimilar, Prolia) in Mar 2026, with launch of both biosimilars anticipated in coming mos. Approval was backed by extensive data, incl. analytical & clinical data showing similar efficacy, safety & immunogenicity profile as the reference product Degevma…

ByRidhi RastogiSeptember 29, 2026

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Teva Receives EC Approval for Ponlimsi and Degevma (Biosimilar, Prolia and Xgeva) to Treat Bone and Skeletal Disorders

Shots: The EC has approved Ponlimsi & Degevma, biosimilar versions of Prolia & Xgeva (denosumab), respectively, following the CHMP positive opinion for bone health treatments Approval was based on comprehensive analytical, preclinical, & clinical data, demonstrating comparable quality, safety, & efficacy of Ponlimsi & Degevma to the reference product Ponlimsi & Degevma are anti-RANKL monoclonal…

ByRidhi RastogiNovember 26, 2025

Teva Reports the US FDA Approval of Degevma (Biosimilar, Xgeva)

Teva Receives EC Approval for Ponlimsi and Degevma (Biosimilar, Prolia and Xgeva) to Treat Bone and Skeletal Disorders

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