Ruxience — licensed biologic

Overview

Source: Purple Book

Proprietary name

Ruxience

Proper name

rituximab-pvvr

Licence type

351(k) Biosimilar

BLA number

761103

Applicant

Pfizer Ireland Pharmaceuticals Unlimited Company

Center

CDER

Presentations

2

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/10ML (10MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	July 23, 2019
500MG/50ML (10MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	July 23, 2019

Reference product

Source: Purple Book

This product is licensed with reference to Rituxan (rituximab).

View reference product Search the small-molecule catalogue

Sources for this page

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