Tag Archives: filgrastim

July, 2018

  • 23 July

    FDA Approves Pfizer’s Nivestym, a Biosimilar to Neupogen (filgrastim)

    NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product. “The FDA approval of NIVESTYM marks an important step in helping expand access to critical treatment options …

March, 2015

  • 6 March

    FDA Approves Sandoz Zarxio as First Biosimilar in the US Market

    Sandoz, a Novartis company, is the first company to receive approval of a biosimilar in the US through the new biosimilars pathway. The US Food and Drug Administration (FDA) approved Sandoz’s Zarxio (filgrastim-sndz) for all indications included in the label of the reference product, Neupogen. Amgen’s Neupogen (filgrastim) was originally …