Xbonzy (denosumab)
- Region
- 🇪🇺 EU
- Active substance
- denosumab
- Company
- Reddy Holding 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
- Application
- EMEA/H/C/006722
- 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
Xbonzy (denosumab) approved in the EU
Marketing authorisation to Reddy Holding GmbH; Biosimilar · source
Same substance in other markets
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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.