On May 8, 2019, the Federal Circuit issued a precedential opinion affirming a district court’s finding of noninfringement in an action brought under the Biologics Price Competition and Innovation Act (“BPCIA”). Amgen Inc. et...more
6/13/2019
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Sandoz ,
Sandoz v Amgen
Click here for PDF On May 10, 2019, the United States Food and Drug Administration (FDA) issued a new draft Guidance entitled Considerations in Demonstrating Interchangeability With a Reference Product....more
In Sandoz Inc. v. Amgen Inc., No. 15-1039 (U.S. June 12, 2017) the Supreme Court held (i) that biosimilar applicants may provide the requisite 180-days’ notice of commercial marketing to the reference product sponsor even...more