FDA approves Teva's Degevma as biosimilar to Xgeva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration has approved DEGEVMA™ (denosumab-adet) as a biosimilar to Xgeva® (denosumab), according to a company statement.

DEGEVMA is indicated for the prevention of bone complications in adults with advanced cancer that has spread to the bone, for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone, and for the treatment of hypercalcemia of malignancy.

The approval marks Teva's second FDA-approved biosimilar in 2026. Combined with PONLIMSI™ (denosumab-adet), which received FDA approval in March 2026 as a biosimilar to Prolia® (denosumab), the two products form Teva's denosumab biosimilar portfolio covering the indications of both reference products.

The FDA's approval was based on a totality of evidence, including analytical and clinical data demonstrating a similar efficacy, safety, and immunogenicity profile compared to the reference product. DEGEVMA is a human monoclonal antibody that inhibits the RANKL protein, reducing bone resorption and cancer-induced bone destruction.

Teva said it anticipates launching both DEGEVMA and PONLIMSI in the U.S. in the coming months. DEGEVMA is already approved in the European Union, where it was authorized on November 18, 2025. The product will be available as a 120mg/1.7mL solution for injection in a vial.

Xgeva® and Prolia® are registered trademarks of Amgen, Inc.

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