Biosimilars: Supreme Court Grants Certiorari in Amgen v. Sandoz

On Friday, January 13, the Supreme Court granted certiorari in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). The Supreme Court originally deferred its decision on the parties’ certiorari petitions in order to consider the Solicitor General’s views. See prior post. On December 7, the Solicitor General filed a briefing recommending that certiorari be granted. See prior post.

The case involves issues central to the application of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), the statutory scheme establishing an abbreviated pathway for regulatory approval of follow-on biologic products. More information on the Federal Circuit’s decision being appealed can be found here and here.

In granting certiorari, the Supreme Court consolidated the cases (Amgen’s petition and Sandoz’s cross-petition). Briefing on the merits should be completed by the end of April, and the case should be called for oral argument in the late spring or early summer.