The FDA has accepted for review a Biologics License Application (BLA) for a biosimilar candidate (TPI-G-CSF) referencing Neupogen (filgrastim).- Adello Biologics.

Adello Biologics announced that FDA has accepted for review the company’s Biologics License Application (BLA) for a biosimilar candidate (TPI-G-CSF) referencing Neupogen (filgrastim). Filgrastim is a short acting granulocyte-colony stimulating factor that increases the body’s production of white blood cells for a number of conditions, including neutropenia in cancer patients receiving myelosuppressive chemotherapy. The BLA submission is supported by similarity data from analytical, pre-clinical and clinical development studies, comparing the biosimilar candidate to Neupogen.

Comment:Since Amgen's principal European patent related to filgrastim was due to expire in August 2006, the company launched a long acting formulation, a pegylated filgrastim (pegfilgrastim), under the brand name Neulasta in 2002. The move, part of Amgen's product lifecycle management strategy, resulted in Neulasta replacing Neupogen in major treatment centers. Amgen's US patent for Neupogen expired in December 2013. Neulasta's patent expired in December 2015 though it is subject to ongoing litigation