The FDA has approved denosumab-adet (Degevma) as a biosimilar to denosumab (Xgeva), covering all of the reference product's indications. These include preventing skeletal-related events (SREs) in patients with multiple myeloma or bone metastases from solid tumors, treating unresectable giant cell tumor of bone (GCTB), and managing hypercalcemia of malignancy refractory to bisphosphonate therapy.

The approval is based on a totality of evidence — analytical and clinical data — demonstrating no clinically meaningful differences from Xgeva in efficacy, safety, and immunogenicity. Paired with Teva's March 2026 FDA approval of denosumab-adet (Ponlimsi) as a Prolia biosimilar, the company now has a comprehensive denosumab biosimilar portfolio spanning both reference products, with US launches expected in the coming months.

Key Takeaways:

• Degevma works by binding to RANKL, inhibiting osteoclast activity and reducing cancer-driven bone destruction
• Pre-existing hypocalcemia must be corrected before starting treatment; calcium monitoring is especially critical in patients with creatinine clearance <30 mL/min or on dialysis
• Key warnings include osteonecrosis of the jaw, atypical femoral fractures, severe hypocalcemia, and embryo-fetal toxicity

Why it matters: Biosimilar approvals can expand patient access to critical bone-protective therapies at potentially lower costs — a meaningful development for cancer patients already navigating complex and expensive treatment regimens.