Pegfilgrastim, sold under the brand name Neulasta among others, is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. It serves to stimulate the production of white blood cells (neutrophils). Pegfilgrastim was developed by Amgen.Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours).Pegfilgrastim was approved for medical use in the United States in January 2002, in the European Union in August 2002, and in Australia in September 2002. Medical uses
Pegfilgrastim is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in people with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia; and to increase survival in people acutely exposed to myelosuppressive doses of radiation (hematopoietic subsyndrome of acute radiation syndrome). Biosimilars
Ristempa was approved for medical use in Australia in January 2017.Tezmota was approved for medical use in Australia in March 2018.Pegfilgrastim-jmdb (Fulphila) was approved for medical use in the United States in June 2018.Fulphila was approved for medical use in Australia in August 2018.Pelgraz was approved for medical use in the European Union in September 2018.Udenyca was approved for medical use in the European Union in September 2018.On November 2, 2018, Coherus Biosciences received FDA approval for its biosimilar, pegfilgrastim-cbqv (Udenyca).
14 July 2021.