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Starjemza
ustekinumab-hmny
351(k) Interchangeable Pharmacy-substitutable
Overview
Source: Purple BookProprietary name
Starjemza
Proper name
ustekinumab-hmny
Licence type
351(k) Interchangeable
BLA number
761419
Applicant
Bio-Thera Solutions, Ltd.
Center
CDER
Presentations
4
First licensure
—
351(k) biosimilar pathway. This product was licensed as highly
similar to a reference product, with no clinically meaningful differences in
safety, purity or potency.
It also carries the interchangeable designation, so a pharmacist may substitute it for the reference product without contacting the prescriber.
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 130MG/26ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | May 22, 2025 |
| 45MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | May 22, 2025 |
| 45MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | May 22, 2025 |
| 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | May 22, 2025 |
Reference product
Source: Purple BookThis product is licensed with reference to Stelara (ustekinumab).
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |