Jul 30, 2014

The Race is on! Anxiously Waiting for the First U.S. Biosimilar to Cross the Finish Line

On July 24, 2014, Sandoz Inc. (Sandoz) became the first company to publicly announce acceptance by the U.S. Food and Drug Administration (FDA) of a biologics license application under the biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA). Specifically, Sandoz is seeking licensure for a version of the protein filgrastim.
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