The FDA’s consideration of a biosimilar drug could open up biologic drug research. Learn how…
Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor analog filgrastim. It serves to stimulate the level of white blood cells. Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours).
Multiple major pharma companies have been busy developing biosimilar drugs of the the original “innovator” pegfilgrastim product (Neulasta).
February 2016, EMA accepts Sandoz’s pegfilgrastim biosimilar submission
On March 6, 2015, the FDA approved the United States’s first biosimilar product, the biosimilar of filgrastim called filgrastim-sndz (trade name Zarxio) by Sandoz,which is biosimilar to to Amgen’s Neupogen.