By Andrew Williams -- As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for approval of biosimilar drug products. Unfortunately, the decision was, much like the BPCIA itself, anything but clear. Judge Newman joined Judge Lourie with regard to whether the Notice of Commercial Marketing had to occur after the FDA approved, or licensed, the biosimilar drug product -- it does. But, Judge Chen joined Judge Lourie with regard to whether the aBLA...
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