Supreme Court to Consider Biologics Price Competition and Innovation Act


On Friday, Jan. 13, the Supreme Court granted the appellant's petition and the respondent's cross-petition for a writ of certiorari in Sandoz Inc. v. Amgen Inc. This is the first time the Court will construe the Biologics Price Competition and Innovation Act of 2009 , the law that established a regulatory pathway for approval of "biosimilar" drugs and set forth a complex scheme for resolving patent disputes between the biosimilar applicant and the sponsor of the reference product.



from Biotech News