Inflectra — licensed biologic

Overview

Source: Purple Book

Proprietary name

Inflectra

Proper name

infliximab-dyyb

Licence type

351(k) Biosimilar

BLA number

125544

Applicant

CELLTRION, Inc.

Center

CDER

Presentations

1

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 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
100MG	For Injection	Intravenous	Single-Dose Vial	Rx	April 5, 2016

Reference product

Source: Purple Book

This product is licensed with reference to Remicade (infliximab).

View reference product Search the small-molecule catalogue

Sources for this page

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