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
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]