FDA approves Teva's DEGEVMA biosimilar to Xgeva across all reference-product indications
The FDA has approved Teva's DEGEVMA as a biosimilar to Xgeva across all reference-product indications, expanding competition in denosumab treatment.
DEGEVMA (denosumab-adet) is approved for indications including prevention of skeletal complications in adults with advanced cancer involving bone, giant cell tumour of bone and hypercalcaemia of malignancy.
The approval marks Teva's second FDA-approved biosimilar of 2026 and adds another denosumab option to the US biologics market.
Field | Content |
Article Type | Approvals |
Drug Name | Denosumab-adet |
Brand Name | DEGEVMA |
Company | Teva Pharmaceuticals |
Reference Product | Xgeva (denosumab) |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | Biosimilar approval |
Indications | All approved reference-product indications |
Therapy Areas | Oncology; bone disease |
Technology/Modality | Monoclonal antibody biosimilar |
Geography | United States |
What Happened | The FDA approved DEGEVMA as a biosimilar to Xgeva across all indications of the reference product. |
Why It Matters | The approval expands biosimilar competition for denosumab and may increase treatment options for patients requiring Xgeva-class therapy. |
Supporting Context | Indications include prevention of bone complications associated with advanced cancer, giant cell tumour of bone and hypercalcaemia of malignancy. |
Strategic Context | DEGEVMA is Teva's second FDA-approved biosimilar of 2026. |
Potential Impact | Additional biosimilar competition could broaden access to denosumab therapy in the United States. |
Key Takeaway | DEGEVMA gives Teva an FDA-approved biosimilar to Xgeva across all reference-product indications. |
What to Watch | US commercial launch, pricing, payer coverage and adoption relative to Xgeva and competing denosumab biosimilars. |
Primary Source | Teva Pharmaceuticals |
Relevant Date | 28 September 2026 |
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