Teva wins US FDA approval for Xgeva biosimilar DEGEVMA
TEVA•Teva won FDA approval for DEGEVMA, a biosimilar to Amgen’s Xgeva, with a label covering Xgeva’s full uses. U.S. launches of DEGEVMA and PONLIMSI are expected in coming months.
1. Approval and launches
The FDA cleared Teva’s DEGEVMA (denosumab-adet), a biosimilar to Amgen’s Xgeva. Its label covers Xgeva’s full uses, including prevention of bone complications in advanced cancer with bone metastases. The approval follows FDA clearance of PONLIMSI in March 2026, giving Teva a U.S. denosumab biosimilar portfolio across Xgeva and Prolia; U.S. launches of DEGEVMA and PONLIMSI are expected in coming months.
