Teva Scores FDA Approval for Xgeva Biosimilar

Teva Pharmaceuticals has gained FDA approval for its biosimilar Degevma (denosumab-adet), which will compete with Amgen's Xgeva (denosumab) in the US market. The FDA approved Degevma to prevent bone complications in adults with advanced cancer that has spread to the bone, as well as to treat giant cell tumor of bone and hypercalcemia of malignancy.

The approval is significant because it establishes a comprehensive US denosumab biosimilar portfolio spanning the indications of both Xgeva and Amgen's Prolia (denosumab). This will provide expanded access to biologic treatment options for patients with oncology-related bone disease and osteoporosis. Teva plans to launch Degevma in the United States in the coming months, aligning with its broader biosimilar commercialization strategy.

Biologics like denosumab represent a significant portion of healthcare expenditures, particularly in oncology. The introduction of biosimilars is critical to driving down systemic healthcare costs while broadening patient access to complex, life-enhancing medications. Teva anticipates that its biosimilar will help reduce healthcare costs and improve treatment options for patients.