Teva Pharmaceutical Industries has received U.S. Food and Drug Administration (FDA) approval for DEGEVMA™ (denosumab-adet), a biosimilar to Amgen’s Xgeva®. The approval covers all indications for Xgeva, including preventing bone complications such as fractures in adults with advanced cancer that has spread to the bone.
The approval is Teva’s second FDA-approved biosimilar in 2026 and supports the company’s “Pivot to Growth” strategy. Data showed DEGEVMA has a safety and efficacy profile comparable to Xgeva’s, positioning it as a more affordable treatment option.
Together with its previously approved biosimilar PONLIMSI™, DEGEVMA gives Teva a denosumab biosimilar portfolio in the U.S.