Xbryk (denosumab)
- Region
- 🇪🇺 EU
- Active substance
- denosumab
- Company
- Samsung Bioepis NL B.V.
- Status
- Authorised
- Therapeutic area
- Neoplasms, Bone Tissue; Giant Cell Tumor of Bone
- CHMP opinion
- Thu 14 Nov 2024
- EU approval
- Wed 12 Feb 2025
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006468
- 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 (see section 5.1). 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
No milestones recorded in the last year.
Same substance in other markets
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- 🇺🇸 Ponlimsi Approved · Teva Pharmaceuticals, Inc.
- 🇪🇺 Wyost Authorised · Sandoz GmbH
- 🇺🇸 Denosumab-Dssb Approved · Samsung Bioepis Co Ltd
- 🇪🇺 Denosumab Ascend Authorised · Ascend GmbH
- 🇪🇺 Denbrayce Authorised · Mabxience Research SL
- 🇪🇺 Degevma Authorised · Teva 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.