FDA approved the original biologics license application for STARJEMZA on May 22, 2025, sponsored by BIO-THERA SOLUTIONS LTD. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- BLA761419
- Sponsor
- BIO-THERA SOLUTIONS LTD
- Original approval
- Review
- standard review
- Submission class
- Type 2 - New Active Ingredient
- Active ingredient
- ustekinumab-hmny
Browse every approval whose brand starts with S, 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 |
|---|---|---|---|
| ustekinumab-hmny 130MG/26ML | INJECTABLE | SUBCUTANEOUS | Prescription |
| ustekinumab-hmny 90MG/ML | INJECTABLE | SUBCUTANEOUS | Prescription |
| ustekinumab-hmny 45MG/0.5ML | 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.
Other approvals to BIO-THERA SOLUTIONS LTD
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