Denosumab Biosimilar Approved For Existing Oncology Indications

The FDA has approved Degevma (denosumab-adet) as a biosimilar to denosumab (Xgeva) across all indications of the reference product.

The approval covers the prevention of skeletal-related events in adults with bone metastases from solid tumors, the treatment of adults and skeletally mature adolescents with giant cell tumor of bone (GCTB) that is unresectable or for which surgical resection is likely to result in severe morbidity, and the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Degevma marks Teva's second FDA-approved biosimilar of 2026 and, paired with Ponlimsi (denosumab-adet), a biosimilar to Prolia (denosumab) approved by the FDA in March 2026, covering the indications in oncology-related bone disease and osteoporosis care.

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

Regulatory Basis for Approval

The FDA's approval of Degevma was supported by a totality-of-evidence package, including analytical and clinical data intended to demonstrate a similar efficacy, safety, and immunogenicity profile to the approved biologic. According to the company, the data package showed no clinically meaningful differences from the reference product in safety, purity, or potency. Degevma is a human monoclonal IgG2 antibody that binds RANKL, a protein essential to osteoclast formation, function, and survival; by blocking the RANKL-RANK interaction, it reduces bone resorption in cortical and trabecular bone. It will be supplied as a 120-mg/1.7-mL solution for injection in a vial.

Safety Considerations

In patients with bone metastases from solid tumors, the most common adverse reactions were fatigue/asthenia, hypophosphatemia, and nausea, with dyspnea the most common serious reaction. In patients with multiple myeloma, the most common adverse reactions included diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache, with osteonecrosis of the jaw the most common serious reaction.

Broader Biosimilar Development Context

Teva said it anticipates launching both Degevma and Ponlimsi in the US in the coming months; Degevma is already approved in the European Union. The approval comes as part of a series of denosumab biosimilars in the US, with multiple previous FDA approvals of other denosumab biosimilars, part of a growing field of interchangeable options for preventing skeletal-related events and treating GCTB and hypercalcemia of malignancy. The company described its strategy as being aimed at broadening patient access to complex biologic therapies while helping offset rising costs across oncology care.

“The last thing a person living with a cancer diagnosis or their families should have to worry about is access to their medicine,” Thomas Rainey, senior vice president of US biosimilars at Teva, stated 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.”

REFERENCE

1. Teva Continues Biosimilar Momentum with U.S. FDA Approval of DEGEVMA™ (denosumab-adet), a Biosimilar to Xgeva® (denosumab). News release. Teva Pharmaceutical Industries Ltd. September 28, 2026. Accessed September 30, 2026. https://tinyurl.com/bdfdejwf