How many Neulasta biosimilars are approved?

Drug Landscape tracks 7 approved Neulasta biosimilars across global regulators. 0 additional applications are filed and 0 are in Phase 3.

Is Neulasta still patent-protected?

All tracked patents on Neulasta have expired in tracked territories.

What is a biosimilar?

A biosimilar is a biological medicine highly similar to an already-approved reference biologic (the originator), with no clinically meaningful differences in safety, purity, or potency. Approved via abbreviated regulatory pathways once the originator's data exclusivity and patents expire.

Last reviewed 2026-05-14 · How we verify

Neulasta biosimilars

Complete Neulasta (PEGFILGRASTIM) biosimilar landscape: 7 approved biosimilars, 0 filed, 0 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

7 approved 0 filed 0 Phase 3 All key patents expired

About Neulasta

Neulasta (PEGFILGRASTIM) — originally marketed by Amgen. Class: Leukocyte Growth Factor [EPC]. Target: Granulocyte colony-stimulating factor receptor. Area: Hematology. First approved 2002-01-01.

Approved biosimilars (7)

Biosimilar	Sponsor	Phase	First approval
Neulasta	Amgen	marketed	2002-01-01
FULPHILA	MYLAN GMBH	marketed
FYLNETRA	KASHIV BIOSCIENCES LLC	marketed
STIMUFEND	FRESENIUS KABI USA	marketed
ARMLUPEG	LUPIN LTD	marketed
ZIEXTENZO	SANDOZ INC	marketed
Pegfilgrastim-Cbqv	Coherus Oncology, Inc.	marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (0)

No biosimilars in Phase 3 clinical trials.

Originator patent timeline

Active patents (0)

No active patents tracked.

Expired patents (0)

No expired patents tracked.

Subscribe to biosimilar updates

Every regulatory action on Neulasta or any of its biosimilars: