Teva Approves DEGEVMA as Second FDA-Approved Biosimilar in 2026

Teva Pharmaceutical Industries Ltd. has expanded its biosimilar portfolio with the FDA approval of DEGEVMA™ (denosumab-adet), a biosimilar to Xgeva® (denosumab). This approval marks the company's second FDA-approved biosimilar in 2026, following the March 2026 approval of PONLIMSI™ (denosumab-adet). Together, these biosimilars establish a comprehensive denosumab biosimilar portfolio in the U.S., covering the indications of both Xgeva® and Prolia®.

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 underscores Teva’s commitment to providing high-quality, more affordable treatment options to patients across complex therapeutic categories.

DEGEVMA is a human monoclonal antibody that binds to the RANKL protein, an essential regulator of osteoclast formation, function, and survival. By inhibiting RANKL, DEGEVMA decreases bone resorption and cancer-induced bone destruction. The comprehensive data package submitted to the FDA demonstrated that DEGEVMA has no clinically meaningful differences from the reference product in terms of safety, purity, and potency.

Teva anticipates launching DEGEVMA and PONLIMSI in the U.S. in the coming months, aligning with its broader biosimilar commercialization strategy. DEGEVMA is currently approved in the European Union, where it was approved on November 18, 2025. The approval was based on a totality of evidence, including analytical and clinical data demonstrating similar efficacy, safety, and immunogenicity profiles as the reference product, Xgeva®.

The approval of DEGEVMA is part of Teva’s Pivot to Growth strategy, which aims to bring high-quality, more affordable treatment options to patients. The company’s Quarterly Report on Form 10-Q for the second quarter of 2026, including in the year ended December 31, 2025, highlights the significance of this approval.

Teva’s commitment to expanding access to important biologic medicines is further underscored by the approval of DEGEVMA. The company’s biosimilars portfolio now spans the indications of both Xgeva® and Prolia®, providing expanded treatment options for patients in oncology-related bone disease and osteoporosis care.