FDA's Worst Case Scenario: Supreme Court Might Defer To It On Biosimilars

27 Apr 2017

During oral arguments in Sandoz v Amgen, justices suggest FDA issue rule-making on whether biosimilar sponsors can give early notification of launches and need to follow all the steps in the patent dance. The agency has explicitly said it wants to be left out of it.

US Supreme Court justices seemed to disagree on whether a biosimilar sponsor must wait until FDA approval to provide notice it intends to market its product and whether the sponsor must hand over its application and manufacturing process information to the innovator.

During oral arguments April 26 in Sandoz Inc. v. Amgen Inc., Chief Justice John Roberts Jr. and Justices...