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# FDA Approves Pfizer’s Neupogen Biosimilar
- URL: https://www.fdaweb.com/fda-approves-pfizers-neupogen-biosimilar/
- Published: 2018-07-20T12:00:00.000Z
- Updated: 2026-09-15T00:20:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141929

FDA has approved a Pfizer BLA for Nivestym (filgrastim-aafi), a biosimilar product referencing Amgen’s Neupogen, indicated for treating neutropenia. Filgrastim is a short acting granulocyte-colony stimulating factor that increases the body’s production of white blood cells. The BLA submission is supported by similarity data from analytical, pre-clinical and clinical development studies, comparing the biosimilar candidate to Neupogen, according to Pfizer.