What biosimilars are approved for pegfilgrastim (Neulasta)?

The FDA Purple Book lists 8 approved follow-on biologics referencing pegfilgrastim: Fulphila, Udenyca, Ziextenzo, Nyvepria, Fylnetra, Stimufend, Armlupeg, and Ennumo. Of these, 0 are interchangeable biosimilars and 8 are 351(k) biosimilars.

Who makes pegfilgrastim biosimilars?

Companies with FDA-approved follow-on biologics referencing pegfilgrastim include Biocon Biologics Inc., Accord BioPharma Inc., Sandoz Inc., Hospira Inc., a Pfizer Company, Kashiv BioSciences, LLC, Fresenius Kabi USA, LLC, and Lupin Limited (Biotech Division).

How many patents are listed for pegfilgrastim (Neulasta) in the Purple Book?

1 patent is published in the FDA Purple Book Patent List for pegfilgrastim.

Purple Book reference family · 351(a) biologic

pegfilgrastim (Neulasta)

pegfilgrastim is an FDA-licensed reference biologic from Amgen Inc., with 8 approved follow-on biologics.

351(a) biologicBLA 125031 Amgen Inc.

Biosimilars

Interchangeables

Listed patents

Reference approved

2002

Reference product

Originator biologic

351(a)BLA 125031

Neulasta pegfilgrastim

Also under this BLA: Neulasta Onpro

Amgen Inc.

View full reference-product record

Approved: Jan 31, 2002
Marketing: Rx
Center: CDER
Patents: 1 listed

Exclusivity & patent cliffs

Protection horizon

Reference approval
Approval date of the reference pegfilgrastim product.
Jan 31, 2002
25 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 13, 2022
3 yr 11 mo ago
Patent 9,856,287 expires
Published Purple Book patent expiration.
Jun 21, 2030
in 3 yr 10 mo

Biosimilars & interchangeables for pegfilgrastim

Follow-on biologics

Biosimilars and interchangeable biosimilars referencing pegfilgrastim.
Product	Proper name	Applicant	Type	BLA	Approved
Fulphila	pegfilgrastim-jmdb	Biocon Biologics Inc.	Biosimilar 351(k)	761075	Jun 04, 2018
UdenycaAlso under this BLA: Udenyca Onbody	pegfilgrastim-cbqv	Accord BioPharma Inc.	Biosimilar 351(k)	761039	Nov 02, 2018
Ziextenzo	pegfilgrastim-bmez	Sandoz Inc.	Biosimilar 351(k)	761045	Nov 04, 2019
Nyvepria	pegfilgrastim-apgf	Hospira Inc., a Pfizer Company	Biosimilar 351(k)	761111	Jun 10, 2020
Fylnetra	pegfilgrastim-pbbk	Kashiv BioSciences, LLC	Biosimilar 351(k)	761084	May 26, 2022
Stimufend	pegfilgrastim-fpgk	Fresenius Kabi USA, LLC	Biosimilar 351(k)	761173	Sep 01, 2022
Armlupeg	pegfilgrastim-unne	Lupin Limited (Biotech Division)	Biosimilar 351(k)	761212	Nov 28, 2025
Ennumo	pegfilgrastim-pccg	Accord BioPharma Inc.	Biosimilar 351(k)	761147	May 07, 2026

Published patents

Purple Book patent list

Published Purple Book patents for pegfilgrastim.
Patent	Expires	In
9,856,287	Jun 21, 2030	in 3 yr 10 mo

pegfilgrastim: 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 pegfilgrastim.

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