Sandoz got there first, but Teva is now in the room. The FDA approved DEGEVMA (denosumab-adet) on September 28 as a biosimilar to Xgeva, the denosumab formulation Amgen launched in 2010 for preventing bone complications in adults with cancer that has spread to bone, and for treating giant cell tumor of bone. Xgeva posted $2.08 billion in sales for full-year 2025, a market that biosimilar entrants are now lining up to split.
The competitive picture matters here. Sandoz won FDA approval for Wyost (denosumab-bbdz) in March 2024 as an interchangeable biosimilar to Xgeva, giving it a meaningful head start in formulary negotiations. Interchangeable status lets pharmacists substitute at the point of dispensing without a new prescriber sign-off, an advantage Teva’s DEGEVMA does not currently carry. That distinction will shape how aggressively payers and oncology networks slot DEGEVMA against Wyost in their preferred-product tiers.
Teva’s approved indications for DEGEVMA cover the prevention of skeletal-related events in adults with bone metastases from solid tumors, treatment of giant cell tumor of bone in adults and skeletally mature adolescents, and at least one additional indication per the filing, consistent with the full Xgeva label. The oncology-only scope of Xgeva keeps DEGEVMA separate from the osteoporosis market served by Prolia biosimilars, so Teva is competing in a narrower but still substantial segment. With Xgeva revenue already declining six percent year-over-year before a second biosimilar entered the picture, Amgen faces compounding pricing pressure.
The immediate question is whether DEGEVMA can close the formulary gap against Wyost through price. Without interchangeable designation, Teva likely needs deeper discounts or existing institutional relationships to gain meaningful volume. Watch how quickly major oncology group purchasing organizations add DEGEVMA to contracted formularies in the next two quarters, because that adoption rate will say more about Teva’s real biosimilar momentum than the approval itself does.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
