Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved DEGEVMA™ (denosumab-adet) as a biosimilar to Xgeva® (denosumab). 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 FDA approval of DEGEVMA, together with PONLIMSI (denosumab-adet), which was approved by the FDA in March 2026, establishes a comprehensive U.S. denosumab biosimilar portfolio spanning the indications of both Xgeva® and Prolia® (denosumab), respectively. Now, healthcare professionals and patients are able to gain expanded access to biologic treatment options in oncology-related bone disease and osteoporosis care.