Denosumab-Dssb (denosumab-dssb)
Biosimilar
- Region
- 🇺🇸 US
- Active substance
- denosumab-dssb
- Company
- Samsung Bioepis Co Ltd
- Status
- Approved
- FDA approval
- Wed 29 Oct 2025
- Designations
- Biosimilar
- Application
- BLA761392
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Wed 29 Oct 2025🇺🇸 FDA approval
FDA approves biosimilar Denosumab-Dssb (denosumab-dssb)
Samsung Bioepis Co Ltd; BLA761392; Biosimilar; injectable · source
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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.