The next stop for PEGylated protein drugs: Biosimilar

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).

Pharma Companies & PEGylated Drug Development

Multiple major pharma companies have been busy developing biosimilar drugs of the original “innovator” pegfilgrastim product (Neulasta).

• July 2016, Mylan and Biocon announce regulatory submission for biosimilar pegfilgrastim accepted by EMA
• February 2016, EMA accepts Sandoz’s pegfilgrastim biosimilar submission
• December 2015, Richter’s pegfilgrastim biosimilar application accepted by EMA
• In 2016 Coherus BioSciences is running clinical studies on its own pegfilgrastim biosimilar CHS-1701.
• In July 2016 the US FDA rejected a pegfilgrastim biosimilar application from Sandoz.
• 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.