Jul 23, 2015

The Riddle Wrapped in a Mystery Inside an Enigma - The Federal Circuit Decides Amgen v. Sandoz - Is Anyone Happy?

Background In May 2014, Sandoz filed a biologics license application under the abbreviated pathway of the Biologics Price Competition and Innovation Act (BPCIA) at 42 U.S.C. 262(k) (biosimilar application or aBLA) seeking approval by the U.S. Food and Drug Administration (FDA) to market Zarxio™, a biosimilar of Amgen's Neupogen® (filigrastim) product. On July 8, 2014, […]
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