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).

Multiple major pharma companies have been busy developing biosimilar drugs of the 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.