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Teva获得安进Xgeva的生物仿制药批准

2026-09-29 04:57

The US FDA approved Teva Pharmaceutical Industries' (TEVA) Degvema (denosumab-adet), a biosimilar to Amgen's (AMGN) Xgeva (denosumab), which is indicated to prevent bone damage and complications in cancer patients.
Approval was based on analytical and clinical data showing Degvema has similar efficacy, safety, and immunogenicity profile as Xgeva.
Teva was granted approval for Ponlimsi, a denosumab biosimilar to Amgen's osteoporosis treatment Prolia, in March.
Amgen reported worldwide revenue for Xgeva of $763M in H1 2026.

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