Degevma (denosumab)
- Region
- 🇪🇺 EU
- Active substance
- denosumab
- Company
- Teva GmbH
- Status
- Authorised
- Therapeutic area
- Giant Cell Tumor of Bone; Neoplasms, Bone Tissue
- CHMP opinion
- Thu 18 Sep 2025
- EU approval
- Mon 17 Nov 2025
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006239
- ATC
- M05BX04
- Official record
- www.ema.europa.eu
Indication
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Regulatory milestones
FDA approves biosimilar Degevma (denosumab-adet)
Teva Pharmaceuticals, Inc.; BLA761481; Biosimilar; injectable · source
Degevma (denosumab) approved in the EU
Marketing authorisation to Teva GmbH; Biosimilar, Additional monitoring · source
Same substance in other markets
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- 🇪🇺 Xbonzy Authorised · Reddy Holding GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.