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March 31, 2026

Teva receives FDA approval for Prolia biosimilar

Teva Pharmaceutical has announced the US Food and Drug Administration (FDA) approval for Ponlimsi (denosumab-adet) as a biosimilar to Prolia, alongside the acceptance of its biosimilar candidate applications for Xolair (omalizumab) by both the agency and the European Medicines Agency (EMA).

Teva receives FDA approval for Prolia biosimilar