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Mar 8, 2015

U.S. FDA Approves the First Biosimilar Product

On March 6, 2015, the U.S. Food and Drug Administration (FDA) approved Sandoz Inc.'s (Sandoz) Zarxio as the first biosimilar product for use in the U.S. Specifically, the FDA found Zarxio biosimilar to Amgen Inc.'s Neupogen® (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen® and can be […]
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