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FDA Approves Denosumab Biosimilar for Skeletal-Related Events, GCTB, and ...
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Fusion42 · 30 September 2026 · Fusion42 review
The FDA has approved denosumab-adet (Degevma) as a biosimilar to denosumab (Xgeva) for all indications of the reference product, including prevention of skeletal-related events, giant cell tumor of bone, and hypercalcemia of malignancy. This approval complements the March 2026 approval of denosumab-adet (Ponlimsi) biosimilar for Prolia, expanding Teva Pharmaceuticals' biosimilar portfolio in the US.
This Wire brief sits within Fusion42's coverage of Biotech, and 3 sources have reported it between 28 Sep 2026 and 30 Sep 2026.
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You can now enter the US oncology biologics market with a FDA-approved denosumab biosimilar addressing multiple bone-related cancer complications. Expect increased competition and cost pressure on originator products, creating openings for pricing and market share gains.
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3 sources · first reported 28 Sep 2026 · latest 30 Sep 2026
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