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 …
Tag Archives: filgrastim
July, 2018
March, 2015
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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 …