FDA approves Teva's Degevma, a Xgeva biosimilar for bone-related cancer complications

The FDA has approved Degevma (denosumab-adet), a biosimilar to Xgeva (denosumab). The drug aims to help adults with advanced cancer that has spread to the bone by preventing skeletal-related events. More specifically, it was approved for treating adults and skeletally mature adolescents with giant cell tumor of bone, as well as hypercalcemia of malignancy.

The approval, which Teva announced in a news release issued on Monday, was based on a totality of evidence that included analytical and clinical data that demonstrated no clinically meaningful differences in purity, potency or safety when compared to the reference product Xgeva.

"Our R&D mission is grounded in a clear commitment: translating complex biologic science into high-quality treatment options that address patient needs," said Rob Cook, head of global technical development and generics R&D at Teva, in the news release. "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."

Teva expects to launch both Degevma and Ponlimsi (denosumab-adet) in the U.S. in the coming months as part of its broader biosimilar commercialization strategy.

Ponlimsi, Teva's biosimilar to Prolia (denosumab), was approved by the FDA in March 2026. Where Degevma covers the Xgeva indications (bone complications in cancer, giant cell tumor of bone, hypercalcemia of malignancy), Ponlimsi corresponds to Prolia's use in osteoporosis. Together, the two give Teva a full denosumab biosimilar lineup spanning both oncology-related bone disease and osteoporosis care.

"The last thing a person living with a cancer diagnosis or their families should have to worry about is access to their medicine," added Thomas Rainey, senior vice president, U.S. Biosimilars at Teva, in the news release. "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 healthcare systems with a high-quality biosimilar."

Why the approval of Degevma matters

Since 2015, biosimilars have generated $81.6 billion in savings for patients and the U.S. healthcare system, including $56 billion for the system itself, according to Cardinal Health's 2026 biosimilar report. Those savings are driven by price: per the HHS, biosimilars launch "on average 50% less than the reference brand biologic price," giving approvals like Degevma’s the potential to bring immediate cost relief for patients receiving denosumab therapy.

Still, growth in the biosimilar market isn't guaranteed. The Office of the Assistant Secretary for Planning and Evaluation points to physician and patient buy-in, patent litigation, and interchangeability status as ongoing barriers to faster biosimilar development — challenges Teva will need to navigate as it works to bring Degevma and Ponlimsi to market.

The approval also reflects a broader shift underway in the biosimilars market, which is entering a new phase of growth as more than $230 billion in biologic originator value is expected to lose exclusivity over the next decade. Teva has pointed to Degevma as evidence of its commitment to expanding its biosimilars portfolio and bringing more treatment options to patients. The company said it plans to lean on its commercial infrastructure, strategic partnerships and global supply capabilities to navigate the payer and policy landscape as it works to simplify adoption and expand access — factors likely to shape how quickly Degevma and Ponlimsi gain traction once they reach the market.