Teva wins EC nod for Prolia and Xgeva biosimilars

25 November 2025

Israel’s Teva Pharmaceutical Industries (NYSE: TEVA) has announced that the European Commission (EC) has granted marketing authorizations for its two denosumab biosimilar candidates.

Teva’s approved products are Ponlimsi, a biosimilar to Prolia, and Degevma, a biosimilar to Xgeva. Both the reference products were developed by US biotech major Amgen (Nasdaq: AMGN).

An important step forward in increasing patient access to biosimilar therapies for serious bone conditions

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