Tofidence — licensed biologic

Overview

Source: Purple Book

Proprietary name

Tofidence

Proper name

tocilizumab-bavi

Licence type

351(k) Biosimilar

BLA number

761354

Applicant

Biogen MA Inc.

Center

CDER

Presentations

3

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

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
200MG/10ML (20MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	September 29, 2023
400MG/20ML (20MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	September 29, 2023
80MG/4ML (20MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	September 29, 2023

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