RxBNNeulasta
pegfilgrastim
1 reference · 9 biosimilar-only
Reference Product
Neulasta
pegfilgrastim
351(a) Reference Product (Approval Date 31-Jan-2002)
ApplicantAmgen Inc.
BLA125031
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Neulasta
pegfilgrastim
351(a) Reference Product (Approval Date 31-Jan-2002)
ApplicantAmgen Inc.
BLA125031
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Interchangeable Biosimilars
No interchangeable biosimilars in this group.
Biosimilars (not interchangeable)
Armlupeg
pegfilgrastim-unne
351(k) Biosimilar (Approval Date 28-Nov-2025)
ApplicantLupin Limited (Biotech Division)
BLA761212
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Armlupeg
pegfilgrastim-unne
351(k) Biosimilar (Approval Date 28-Nov-2025)
ApplicantLupin Limited (Biotech Division)
BLA761212
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Ennumo
pegfilgrastim-pccg
351(k) Biosimilar (Approval Date 7-May-2026)
ApplicantAccord BioPharma Inc.
BLA761147
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Ennumo
pegfilgrastim-pccg
351(k) Biosimilar (Approval Date 7-May-2026)
ApplicantAccord BioPharma Inc.
BLA761147
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Fulphila
pegfilgrastim-jmdb
351(k) Biosimilar (Approval Date 4-Jun-2018)
ApplicantBiocon Biologics Inc.
BLA761075
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Fulphila
pegfilgrastim-jmdb
351(k) Biosimilar (Approval Date 4-Jun-2018)
ApplicantBiocon Biologics Inc.
BLA761075
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Fylnetra
pegfilgrastim-pbbk
351(k) Biosimilar (Approval Date 26-May-2022)
ApplicantKashiv BioSciences, LLC
BLA761084
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Fylnetra
pegfilgrastim-pbbk
351(k) Biosimilar (Approval Date 26-May-2022)
ApplicantKashiv BioSciences, LLC
BLA761084
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Nyvepria
pegfilgrastim-apgf
351(k) Biosimilar (Approval Date 10-Jun-2020)
ApplicantHospira Inc., a Pfizer Company
BLA761111
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Nyvepria
pegfilgrastim-apgf
351(k) Biosimilar (Approval Date 10-Jun-2020)
ApplicantHospira Inc., a Pfizer Company
BLA761111
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Stimufend
pegfilgrastim-fpgk
351(k) Biosimilar (Approval Date 1-Sep-2022)
ApplicantFresenius Kabi USA, LLC
BLA761173
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Stimufend
pegfilgrastim-fpgk
351(k) Biosimilar (Approval Date 1-Sep-2022)
ApplicantFresenius Kabi USA, LLC
BLA761173
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Udenyca
pegfilgrastim-cbqv
351(k) Biosimilar (Approval Date 2-Nov-2018)
ApplicantAccord BioPharma Inc.
BLA761039
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Udenyca
pegfilgrastim-cbqv
351(k) Biosimilar (Approval Date 2-Nov-2018)
ApplicantAccord BioPharma Inc.
BLA761039
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Udenyca Onbody
pegfilgrastim-cbqv
351(k) Biosimilar (Approval Date 22-Dec-2023)
ApplicantAccord BioPharma Inc.
BLA761039
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Udenyca Onbody
pegfilgrastim-cbqv
351(k) Biosimilar (Approval Date 22-Dec-2023)
ApplicantAccord BioPharma Inc.
BLA761039
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Ziextenzo
pegfilgrastim-bmez
351(k) Biosimilar (Approval Date 4-Nov-2019)
ApplicantSandoz Inc.
BLA761045
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Ziextenzo
pegfilgrastim-bmez
351(k) Biosimilar (Approval Date 4-Nov-2019)
ApplicantSandoz Inc.
BLA761045
·RouteSubcutaneous
Presentation
Pre-Filled Syringe