Sandoz Asks Supreme Court To Reverse Biosimilar Decision

On February 16, 2016, Sandoz, Inc. filed a petition for writ of certiorari to the Supreme Court, asking the Court to overturn the Federal Circuit decision that interpreted the "patent dance" provisions of the Biologics Price Competition and Innovation Act (BPCIA) as requiring the biosimilar applicant to give 180 days' pre-marketing notice that cannot be given until after the FDA has "licensed" (approved) the biosimilar product. The Supreme Court may be inclined to hear this case, since it involves an important provision of the BPCIA, and because the decision in effect delays the commercial availability of less expensive biosimilar products that the BPCIA was enacted to provide.

The Neupogen® // Zarxio" Biosimilar Dispute