Jun 7, 2015

Federal Circuit Hears Oral Arguments in Litigation Involving the First U.S. Biosimilar Product

On July 24, 2014, Sandoz became the first company to announce acceptance by the U.S. Food and Drug Administration (FDA) of a biologics license application under the abbreviated pathway of the BPCIA at 42 U.S.C. 262(k). The application was for approval to market Zarxio™, a biosimilar of Amgen's Neupogen® (filigrastim) product.
back to top