FDA approves Teva’s DEGEVMA biosimilar to Xgeva across all reference product indications

The U.S. Food and Drug Administration has approved Teva’s DEGEVMA, also known as denosumab adet, as a biosimilar to Xgeva for all indications of the reference medicine.

DEGEVMA is approved to help prevent bone complications in adults with advanced cancer that has spread to the bone.

The treatment can also be used in adults and skeletally mature adolescents with giant cell tumour of bone, as well as in patients with hypercalcaemia of malignancy.

The approval expands Teva’s denosumab biosimilar portfolio in the U.S.

In March 2026, the FDA approved the company’s PONLIMSI, also known as denosumab adet, as a biosimilar to Prolia.

Together, DEGEVMA and PONLIMSI provide Teva with biosimilar versions covering the indications of both Xgeva and Prolia.

Teva said the two products could broaden access to biologic medicines used across oncology related bone disease and osteoporosis care.

DEGEVMA is Teva’s second FDA approved biosimilar of 2026 and forms part of the company’s wider Pivot to Growth strategy.

Rob Cook, Head of Global Technical Development and Generics Research and Development at Teva, said the approval reflects the company’s efforts to translate complex biologic science into treatments that can address patient needs.

He said DEGEVMA also demonstrates Teva’s internal biosimilar development capabilities and its aim of expanding access to important biologic medicines.

The FDA decision was supported by a totality of evidence package that included analytical and clinical data.

The evidence demonstrated that DEGEVMA has no clinically meaningful differences from Xgeva in terms of safety, purity and potency.

Teva also reported comparable efficacy, safety and immunogenicity between the biosimilar and the reference medicine.

DEGEVMA is a human monoclonal antibody that binds to RANKL, a protein involved in the formation, activity and survival of osteoclasts.

By inhibiting RANKL, the treatment reduces bone resorption and bone destruction associated with cancer.

Thomas Rainey, Senior Vice President of U.S. Biosimilars at Teva, said improving access to medicines is particularly important for people living with cancer and their families.

He said the DEGEVMA approval could provide patients with another treatment option while also supporting healthcare systems through increased biosimilar availability.

Teva said biologic medicines account for a substantial proportion of healthcare spending, particularly in oncology, and that biosimilars can help reduce costs while expanding access to complex treatments.

The company expects to launch both DEGEVMA and PONLIMSI in the U.S. in the coming months.

DEGEVMA has also received approval in the European Union.

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Related Topics and Keywords

biologics, biosimilar, bone health, bone metastases, DEGEVMA, Denosumab, FDA Approval, Giant Cell Tumour, hypercalcemia, Oncology, pharma news, Teva, Xgeva