Nivestym — licensed biologic

Overview

Source: Purple Book

Proprietary name

Nivestym

Proper name

filgrastim-aafi

Licence type

351(k) Biosimilar

BLA number

761080

Applicant

Hospira Inc., a Pfizer Company

Center

CDER

Presentations

4

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
300MCG/0.5ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	July 20, 2018
300MCG/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Rx	July 20, 2018
480MCG/0.8ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	July 20, 2018
480MCG/1.6ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Rx	July 20, 2018

Reference product

Source: Purple Book

This product is licensed with reference to Neupogen (filgrastim).

View reference product Search the small-molecule catalogue

Sources for this page

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