Teva Scores Biosimilar Approval, Takes Aim at Amgen's Xgeva

Teva Pharmaceutical Industries has secured approval from the US FDA for its biosimilar Degevma (denosumab-adet), a copycat version of Amgen's Xgeva (denosumab) used to prevent bone damage in cancer patients.

The approval was based on analytical and clinical data demonstrating that Degevma has a similar efficacy, safety, and immunogenicity profile as Xgeva. This marks the second biosimilar approval for Teva this year, following Ponlimsi, a denosumab biosimilar to Amgen's osteoporosis treatment Prolia, which was granted in March.

Amgen reported worldwide revenue of $763M for Xgeva in H1 2026. The FDA's decision is significant as it allows Teva to compete with Amgen in the market, potentially impacting the company's revenue from Xgeva.