Teva receives FDA approval for Degevma denosumab biosimilar

Teva Pharmaceutical Industries has received FDA approval for Degevma (denosumab-adet), a biosimilar to Amgen’s Xgeva. The drug is indicated to prevent bone complications in adults with advanced cancer that has spread to the bone, to treat hypercalcemia of malignancy, and to treat adults and skeletally mature adolescents with giant cell tumor of bone.

This approval completes Teva’s denosumab biosimilar portfolio. It follows the March 2026 approval of Ponlimsi (denosumab-adet), a biosimilar to Prolia, which is used for postmenopausal osteoporosis. Together, these two products allow Teva to provide biosimilar options for both oncology-related bone disease and osteoporosis care.

The FDA approval was based on analytical and clinical data demonstrating that Degevma has no clinically meaningful differences in safety, purity, or potency compared to the reference product. Teva expects to launch both Degevma and Ponlimsi in the United States in the coming months.