Udenyca — licensed biologic

Overview

Source: Purple Book

Proprietary name

Udenyca

Proper name

pegfilgrastim-cbqv

Licence type

351(k) Biosimilar

BLA number

761039

Applicant

Accord BioPharma Inc.

Center

CDER

Presentations

2

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
6MG/0.6ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	November 2, 2018
6MG/0.6ML	Injection	Subcutaneous	Autoinjector	Rx	March 3, 2023

Reference product

Source: Purple Book

This product is licensed with reference to Neulasta (pegfilgrastim).

View reference product Search the small-molecule catalogue

Sources for this page

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