FDA approved the original biologics license application for DENOSUMAB-DSSB on February 13, 2025, sponsored by SAMSUNG BIOEPIS CO LTD. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- BLA761392
- Sponsor
- SAMSUNG BIOEPIS CO LTD
- Original approval
- Review
- standard review
- Active ingredient
- denosumab-dssb
Browse every approval whose brand starts with D, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| denosumab-dssb 60MG/ML | INJECTABLE | SUBCUTANEOUS | Prescription |
| denosumab-dssb 60MG/ML | INJECTABLE | SUBCUTANEOUS | Prescription |
| denosumab-dssb 70MG/ML | INJECTABLE | SUBCUTANEOUS | Prescription |
| denosumab-dssb 70MG/ML | INJECTABLE | SUBCUTANEOUS | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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