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Tyenne
tocilizumab-aazg
351(k) Biosimilar
Overview
Source: Purple BookProprietary name
Tyenne
Proper name
tocilizumab-aazg
Licence type
351(k) Biosimilar
BLA number
761449
Applicant
Fresenius Kabi USA, LLC
Center
CDER
Presentations
5
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 is licensed as a biosimilar but is not designated interchangeable, so substitution requires the prescriber.
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 162MG/0.9ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | March 14, 2025 |
| 162MG/0.9ML | Injection | Subcutaneous | Autoinjector | Rx | March 14, 2025 |
| 200MG/10ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | March 5, 2024 |
| 400MG/20ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | March 5, 2024 |
| 80MG/4ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | March 5, 2024 |
Reference product
Source: Purple BookThis product is licensed with reference to Actemra (tocilizumab).
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |