pegfilgrastim   Click here for help

GtoPdb Ligand ID: 6969

Synonyms: Neulasta®
Approved drug
pegfilgrastim is an approved drug (FDA and EMA (2002))
Comment: This is a PEGylated version of recombinant human G-CSF. Pegylation increases circulating half-life. In addition to pegfilgrastim, lipegfilgrastim (Lonquex®) is a glyco-PEGylated long-acting G-CSF, that is an alternative to pegfilgrastim that is clinically approved [1].

Biosimilars:
NameTrade nameCompanyClinical phaseIndications
pegfilgrastim-jmbd; MYL-1401HFulphilaMylanApproved (2018 FDA & EMA)As per reference agent [2]
 PelgrazAccordApproved (2018 EMA)As per reference agent
 PelmegMundipharma (developed by Cinfa Biotech)Approved (2018 EMA)As per reference agent
 pegfilgrastim MundipharmaMundipharma Approved (2019 EMA)As per reference agent
pegfilgrastim-cbqv; CHS-1701UdenycaERA Consulting; Coherus BioSciencesApproved (2018 FDA & EMA)As per reference agent
USV pegfilgrastimGrasustekJuta PharmaApproved (2019 EMA)As per reference agent
pegfilgrastim-bmez; LA-EP2006ZiextenzoSandozApproved (2018 EMA, 2019 FDA)As per reference agent
pegfilgrastim-apgf; PF-06881894NyvepriaPfizerApproved (2020 FDA)Indicated for neutropenia in patients undergoing cancer chemotherapy
pegfilgrastim; MSB11455StimufendFresenius KabiApproved (2022 EMA)Indicated for neutropenia
pegfilgrastim-pbbkFylnetraAmneal PharmaceuticalsApproved (2022 FDA)Indicated for neutropenia
References
1. Guariglia R, Martorelli MC, Lerose R, Telesca D, Milella MR, Musto P. (2016)
Lipegfilgrastim in the management of chemotherapy-induced neutropenia of cancer patients.
Biologics, 10: 1-8. [PMID:26858523]
2. Waller CF, Tiessen RG, Lawrence TE, Shaw A, Liu MS, Sharma R, Baczkowski M, Kothekar MA, Micales CE, Barve A et al.. (2018)
A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim.
J Cancer Res Clin Oncol, 144 (6): 1087-1095. [PMID:29671069]