Teva Wins FDA Approval for DEGEVMA Biosimilar to Xgeva

Tel Aviv, Israel, and Parsippany, New Jersey, September 28, 2026

FDA Approval Expands Teva’s Denosumab Portfolio

The approval of DEGEVMA represents Teva’s second FDA-approved biosimilar in 2026. Together with PONLIMSI™ (denosumab-adet), which received FDA approval in March 2026, Teva now has a denosumab biosimilar portfolio covering the indications of both Xgeva and Prolia® (denosumab). According to Teva, this portfolio is intended to expand access to biologic treatment options in oncology-related bone disease and osteoporosis care. DEGEVMA is supplied as a 120 mg/1.7 mL solution for injection in a vial, providing a biosimilar treatment option based on the same active substance, denosumab. The FDA approval was supported by a totality-of-evidence approach, incorporating analytical and clinical data demonstrating comparable efficacy, safety, purity, potency and immunogenicity to the reference product. DEGEVMA is a human monoclonal antibody that targets RANKL, a protein that regulates the formation, function and survival of osteoclasts. By binding to RANKL, denosumab reduces bone resorption and cancer-associated bone destruction. Teva stated that its comprehensive data package demonstrated no clinically meaningful differences between DEGEVMA and Xgeva in the evaluated characteristics.

DEGEVMA Targets Multiple Bone-Related Conditions

DEGEVMA’s U.S. approval includes important indications across oncology and bone disease. The medicine is indicated to help prevent skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors. It is also approved for adults and skeletally mature adolescents with unresectable giant cell tumor of bone, or cases where surgical resection would be expected to cause severe morbidity. In addition, DEGEVMA is approved for hypercalcemia of malignancy that is refractory to bisphosphonate therapy. The introduction of biosimilars is an important component of the pharmaceutical industry’s effort to broaden access to complex biologic medicines. Teva said biologic medicines such as denosumab account for a significant portion of healthcare spending, particularly in oncology, and that biosimilar competition can contribute to greater treatment access and healthcare cost efficiency. The company expects to launch DEGEVMA and PONLIMSI in the United States in the coming months, subject to its commercialization plans. DEGEVMA is also already approved in the European Union, where it received authorization in November 2025.

Teva Advances U.S. Biosimilar Strategy

The FDA decision adds to Teva’s broader strategy of expanding its portfolio of biosimilars and complex medicines. With DEGEVMA and PONLIMSI, the company has developed a comprehensive U.S. denosumab biosimilar offering spanning the indications associated with Xgeva and Prolia. The development and regulatory approval of these products also demonstrate the role of analytical, preclinical and clinical comparability programs in establishing biosimilarity for complex biologic medicines.

For patients and healthcare systems, the approval creates another FDA-approved denosumab biosimilar option for serious bone-related conditions. The development is particularly relevant to oncology, where bone metastases and skeletal complications can substantially affect patient care. Teva’s latest approval therefore represents a significant pharmaceutical regulatory milestone while highlighting the continued expansion of biosimilar competition in the U.S. biologics market.

Source: Teva Pharmaceutical press release