Teva has received US FDA approval for DEGEVMA (denosumab‑adet), a biosimilar to Xgeva, marking a further step in its Pivot to Growth strategy.
The product is authorised across all Xgeva indications, including prevention of bone complications in adults with advanced cancer that has spread to the bone and treatment of giant cell tumour of bone. It is also approved for hypercalcemia of malignancy.
The decision follows the March 2026 approval of PONLIMSI, establishing Teva’s full U.S. denosumab biosimilar portfolio across the reference products Xgeva and Prolia. The company said the expanded offering will support broader access to biologic treatment options in oncology‑related bone disease and osteoporosis care.
Rob Cook, Head of Global Technical Development & Generics R&D at Teva, explained: “Our R&D mission is grounded in a clear commitment: translating complex biologic science into high-quality treatment options that address patient needs.” He added: “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 such as denosumab account for a significant share of healthcare expenditure, particularly in oncology. Teva said biosimilars are essential to reducing systemic costs and improving patient access to complex medicines.
Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva, noted: “The last thing a person living with a cancer diagnosis or their families should have to worry about is access to their medicine.” He continued: “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.”
FDA approval was based on analytical and clinical data showing similar efficacy, safety and immunogenicity to Xgeva. Teva expects to launch DEGEVMA and PONLIMSI in the U.S. in the coming months.
