Bomyntra (denosumab)
Biosimilar
- Region
- 🇪🇺 EU
- Active substance
- denosumab
- Company
- Fresenius Kabi Deutschland GmbH
- Status
- Authorised
- Therapeutic area
- Neoplasms, Bone Tissue; Giant Cell Tumor of Bone
- CHMP opinion
- Thu 22 May 2025
- EU approval
- Thu 17 Jul 2025
- Designations
- Biosimilar
- Application
- EMEA/H/C/006269
- 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
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 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.