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Yesintek
ustekinumab-kfce
351(k) Interchangeable 351(k) Biosimilar Pharmacy-substitutable
Overview
Source: Purple BookProprietary name
Yesintek
Proper name
ustekinumab-kfce
Licence type
351(k) Interchangeable · 351(k) Biosimilar
BLA number
761406
Applicant
Biocon Biologics Inc.
Center
CDER
Presentations
6
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 | November 29, 2024 |
| 45MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | November 29, 2024 |
| 45MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | November 29, 2024 |
| 45MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | August 14, 2026 |
| 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | November 29, 2024 |
| 90MG/ML | Injection | Subcutaneous | Autoinjector | Rx | August 14, 2026 |
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 |