What biosimilars are approved for filgrastim (Neupogen)?

The FDA Purple Book lists 5 approved follow-on biologics referencing filgrastim: Zarxio, Nivestym, Releuko, Nypozi, and Filkri. Of these, 0 are interchangeable biosimilars and 5 are 351(k) biosimilars.

Who makes filgrastim biosimilars?

Companies with FDA-approved follow-on biologics referencing filgrastim include Sandoz Inc., Hospira Inc., a Pfizer Company, Kashiv BioSciences, LLC, Tanvex BioPharma USA, Inc., and Accord BioPharma Inc..

Purple Book reference family · 351(a) biologic

filgrastim (Neupogen)

filgrastim is an FDA-licensed reference biologic from Amgen Inc., with 5 approved follow-on biologics.

351(a) biologicBLA 103353 Amgen Inc.

Biosimilars

Interchangeables

Listed patents

Reference approved

1991

Reference product

Originator biologic

351(a)BLA 103353

Neupogen filgrastim

Amgen Inc.

View full reference-product record

Approved: Feb 20, 1991
Marketing: Rx
Center: CDER
Patents: None listed

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for filgrastim from the RCSB Protein Data Bank (PDB 1RHG).

3D molecular structure of filgrastim (PDB entry 1RHG)

Interactive biological assembly from PDB entry 1RHG. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.

Open in RCSB viewer PDB 1RHG details

Exclusivity & patent cliffs

Protection horizon

Reference approval
Approval date of the reference filgrastim product.
Feb 20, 1991
36 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Mar 30, 2022
4 yr 7 mo ago

Biosimilars & interchangeables for filgrastim

Follow-on biologics

Biosimilars and interchangeable biosimilars referencing filgrastim.
Product	Proper name	Applicant	Type	BLA	Approved
Zarxio	filgrastim-sndz	Sandoz Inc.	Biosimilar 351(k)	125553	Mar 06, 2015
Nivestym	filgrastim-aafi	Hospira Inc., a Pfizer Company	Biosimilar 351(k)	761080	Jul 20, 2018
Releuko	filgrastim-ayow	Kashiv BioSciences, LLC	Biosimilar 351(k)	761082	Feb 25, 2022
Nypozi	filgrastim-txid	Tanvex BioPharma USA, Inc.	Biosimilar 351(k)	761126	Jun 28, 2024
Filkri	filgrastim-laha	Accord BioPharma Inc.	Biosimilar 351(k)	761027	Jan 15, 2026

filgrastim: frequently asked questions

Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.

Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for filgrastim.

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