pegfilgrastim

Ligand id: 6969

Name: pegfilgrastim

Classification
Compound class Peptide or derivative
Approved drug? Yes (FDA and EMA (2002))
International Nonproprietary Names
INN number INN
8114 pegfilgrastim
Comments
This is a PEGylated version of recombinant human G-CSF. Pegylation increases circulating half-life. The EMA granted marketing authorisation for lipegfilgrastim in 2013. Lipegfilgrastim (Lonquex®) is a glyco-PEGylated long-acting G-CSF, that is an alternative to pegfilgrastim [1].

Biosimilars:
In June 2018, the US FDA approved Mylan's biosimilar, Fulphila® (pegfilgrastim-jmbd, MYL-1401H) as a treatment to reduce the duration of febrile neutropenia in patients treated with myelosuppressive anticancer treatments, except for patients with chronic myeloid leukaemia and myelodysplastic syndromes. This was evaluated in Phase 3 breast cancer trial NCT02467868 in direct comparison to the originator product Neulasta®, and regulatory review found no clinically meaningful differences between Fulphila® and Neulasta® in terms of safety, purity and potency [2].
Database Links
Specialist databases
IMGT/mAb-DB 616
Other databases
CAS Registry No. 208265-92-3 (source: Scifinder)
ChEMBL Ligand CHEMBL1201568
DrugBank Ligand DB00019
GtoPdb PubChem SID 178103549
Search PubMed clinical trials pegfilgrastim
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Wikipedia Pegfilgrastim