FDA Accepts Bid to License Neupogen Biosimilar

September 15, 2017

The FDA accepted for review a BLA application from Adello Biologics for a biosimilar to Amgen’s Neupogen (filgrastim).

A short acting granulocyte-colony stimulating factor, filgrastim increases production of white blood cells. It is used to treat neutropenia in cancer patients receiving myelosuppressive chemotherapy, as well as other conditions.

Adello supported its BLA submission with data from analytical, pre-clinical and clinical development studies.

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