Teva Continues Biosimilar Momentum with U.S. FDA Approval of DEGEVMA™ (denosumab-adet), a Biosimilar to Xgeva® (denosumab)
The FDA approved Teva's DEGEVMA (denosumab-adet), a biosimilar to Amgen's Xgeva, across all reference-product indications including prevention of bone complications in advanced cancer, giant cell tumor of bone, and hypercalcemia of malignancy. Together with PONLIMSI (approved March 2026), it gives Teva a comprehensive U.S. denosumab biosimilar portfolio spanning Xgeva and Prolia indications; both launches are expected in the coming months. The approval is Teva's second U.S.
Key figures
- Drug Name
- DEGEVMA (denosumab-adet)
- Phase Of Trial
- biosimilar totality-of-evidence package
- Launch timing
- coming months
- Reference product
- Xgeva (denosumab)
- Second 2026 biosimilar approval
- Yes
AI analysis
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