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Avtozma

tocilizumab-anoh

351(k) Interchangeable 351(k) Biosimilar Pharmacy-substitutable

Overview

Source: Purple Book

Proprietary name

Avtozma

Proper name

tocilizumab-anoh

Licence type

351(k) Interchangeable · 351(k) Biosimilar

BLA number

761498

Applicant

CELLTRION, Inc.

Center

CDER

Presentations

First licensure

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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

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
162MG/0.9ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	January 24, 2025
162MG/0.9ML	Injection	Subcutaneous	Autoinjector	Rx	January 24, 2025
200MG/10ML (20MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	January 24, 2025
400MG/20ML (20MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	January 24, 2025
80MG/4ML (20MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	January 24, 2025

Reference product

Source: Purple Book

This product is licensed with reference to Actemra (tocilizumab).

View reference product Search the small-molecule catalogue

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity