The Supreme Court’s Decision In Amgen v. Sandoz: More Questions Than Answers?

Biosimilar Development
July 6, 2017

On June 12, the Supreme Court issued a unanimous opinion in Amgen v. Sandoz, penned by Justice Clarence Thomas. The Court addressed two questions, stemming from the Federal Circuit’s 2015 decision in the case, on which certiorari had been granted: 1) whether a biosimilar applicant may be compelled under either federal or state law to provide the reference product sponsor with its biosimilar application (aBLA) and manufacturing information; and 2) whether a biosimilar applicant must provide 180 days’ notice of commercial marketing of its biosimilar product only after the product has been licensed by the FDA.

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