Volume 49, Issue 1
Federal Circuit Decides That State Law Is Preempted By Biosimilar Act In Amgen v. Sandoz
By: N. Scott Pierce, Principal and Deirdre E. Sanders, Principal Hamilton Brook Smith Reynolds
Scott PierceDeirdre E. Sanders
December 2017
  • The Federal Circuit held that the Biologics Price Competition and Invention Act of 2009 (BPCIA) provides the exclusive remedy for failure to comply with its disclosure requirements.
  • Because the BPCIA preempts state law claims, Amgen cannot obtain injunctive relief or damages for biosimilar applicant Sandoz’ failure to disclose required information.
  • Since this preemption issue presents “a significant question of general impact or of great public concern” that had been fully briefed, the court determined that the preemption defense had not been waived.