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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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