How many FILGRASTIM biosimilars are approved?

Drug Landscape tracks 5 approved FILGRASTIM biosimilars across global regulators. 0 additional applications are filed and 3 are in Phase 3.

Is FILGRASTIM still patent-protected?

All tracked patents on FILGRASTIM 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

FILGRASTIM biosimilars

Complete FILGRASTIM (FILGRASTIM) biosimilar landscape: 5 approved biosimilars, 0 filed, 3 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

5 approved 0 filed 3 Phase 3 All key patents expired

About FILGRASTIM

FILGRASTIM. Class: Leukocyte Growth Factor [EPC]. Target: Specific cell surface receptors on hematopoietic cells. First approved 1991-01-01.

Approved biosimilars (5)

Biosimilar	Sponsor	Phase	First approval
Neupogen	Amgen	marketed	1991-01-01
RELEUKO	KASHIV BIOSCIENCES LLC	marketed
NYPOZI	TANVEX BIOPHARMA USA INC	marketed
Filgrastim-sndz	M.D. Anderson Cancer Center	marketed
Filgrastim, hrG-CSF	University of Padova	marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (3)

Biosimilar	Sponsor	Phase
Filgrastim SD/01	M.D. Anderson Cancer Center	phase 3
Filgrastim (Eurofarma)	Eurofarma Laboratorios S.A.	phase 3
Filgrastim (G-CSF)	University of Miami	phase 3

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 FILGRASTIM or any of its biosimilars: