Teva Pharmaceutical recently announced that the US 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 US denosumab biosimilar portfolio spanning the indications of both Xgeva and Prolia (denosumab), respectively.

Rob Cook, Head of Global Technical Development and Generics R&D, Teva Pharmaceutical, said, “Our R&D mission is grounded in a clear commitment: translating complex biologic science into high-quality treatment options that address patient needs. The approval of DEGEVMA reflects the scientific, clinical and regulatory expertise behind our in-house biosimilars capabilities and our continued focus on expanding access to important biologic medicines.”

Biologics like denosumab represent a significant portion of healthcare expenditures, particularly in oncology. The introduction of biosimilars is critical to driving down systemic health care costs while broadening patient access to complex, life-enhancing medications.

Thomas Rainey, Senior Vice President, US Biosimilars, Teva Pharmaceutical, said, “The last thing a person living with a cancer diagnosis or their families should have to worry about is access to their medicine. The approval of DEGEVMA is a powerful example of Teva’s Pivot to Growth strategy in action because it represents an important step in expanding treatment options for patients and supporting health care systems with a high-quality biosimilar.”

The FDA approval of DEGEVMA was based on a totality of evidence, including analytical and clinical data demonstrating similar efficacy, safety and immunogenicity profile as the reference product, Xgeva.

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.

The company anticipates launching DEGEVMA and PONLIMSI in the US in the coming months, aligning with its broader biosimilar commercialisation strategy.

DEGEVMA is currently approved in the European Union (EU).