Teva wins FDA approval for DEGEVMA denosumab biosimilar to Xgeva
Teva Pharmaceutical Industries has received US Food and Drug Administration approval for DEGEVMA (denosumab-adet), a biosimilar to Amgen's Xgeva (denosumab). The approval covers prevention of skeletal-related events in adults with bone metastases from solid tumours and multiple myeloma, treatment of giant cell tumour of bone in adults and skeletally mature adolescents, and management of hypercalcemia of malignancy refractory to bisphosphonate therapy.
DEGEVMA is a human monoclonal IgG2 antibody that targets RANKL, the protein responsible for osteoclast formation and function. By blocking the RANKL-RANK interaction, it inhibits bone resorption. The FDA's approval was based on a totality-of-evidence package, including analytical, preclinical and clinical data demonstrating no clinically meaningful differences from Xgeva in safety, purity and potency. The product will be supplied as a 120 mg/1.7 mL solution for injection.
Completing the denosumab portfolio
The DEGEVMA approval arrives alongside Teva's earlier FDA clearance of PONLIMSI (also denosumab-adet) in March 2026, which references Prolia, the denosumab formulation used in osteoporosis. Together, the two biosimilars give Teva coverage across the full set of approved denosumab indications in the US. The company said it anticipates launching both products in the coming months, without specifying a precise date or list price.
Rob Cook, Head of Global Technical Development and Generics R&D at Teva, said the approval "reflects the scientific, clinical and regulatory expertise behind our in-house biosimilars capabilities." Thomas Rainey, Senior Vice President for US Biosimilars, framed it as a patient-access story, noting that cost concerns should not add to the burden of a cancer diagnosis.
DEGEVMA is already approved in the European Union, where Teva received a positive opinion in November 2025.
Market context and competitive landscape
The denosumab biosimilar market is emerging as a meaningful battleground. Xgeva generated several hundred million dollars in annual sales globally for Amgen, making it a commercially attractive reference product for biosimilar developers. Teva is not the only entrant: a number of manufacturers have filed or received approval for denosumab biosimilars in the US and Europe, and the competitive field is likely to intensify through 2026 and 2027 as launches align.
Biologics account for a growing share of oncology drug expenditure, and payers and health systems have been pressing for greater biosimilar uptake in this category. The oncology bone-health segment has historically been slower to adopt biosimilars than some other biologic classes, partly because prescriber familiarity with the originator product is high and partly because reimbursement dynamics in oncology can reduce price sensitivity at the point of prescribing. How aggressively Teva prices and promotes DEGEVMA relative to Xgeva will determine whether it captures meaningful volume.
For Teva, the dual approval reinforces what the company calls its Pivot to Growth strategy, which aims to rebuild its biosimilar and innovative pipeline after years of pressure from generic drug pricing erosion and a restructuring programme. A complete denosumab franchise spanning both bone-metastasis and osteoporosis settings strengthens its position in the US biologics access market and provides a platform for commercial investment across two distinct prescriber bases: oncologists and rheumatologists or general practitioners managing bone density.