Teva Wins FDA Approval for DEGEVMA, a Biosimilar to Xgeva

Teva Pharmaceutical Industries Ltd. (TEVA) said the U.S. Food and Drug Administration approved DEGEVMA, a biosimilar to Xgeva (denosumab), for preventing bone complications in adults with advanced cancer that has spread to bone, treating giant cell tumor of bone in adults and skeletally mature adolescents, and treating hypercalcemia of malignancy. The FDA based its approval on analytical and clinical data showing no clinically meaningful differences from Xgeva in safety, purity and potency, Teva said. DEGEVMA is also approved in the European Union. The approval follows PONLIMSI (denosumab-adet), cleared in March 2026, giving Teva a U.S. denosumab biosimilar portfolio covering Xgeva and Prolia indications. Teva expects to launch both in the U.S. in the coming months. TEVA closed at $38.88 on Monday, down 0.79%, and rose 0.31% to $39.00 after hours, within its 52-week range of $18.83 to $40.79.