Tag Archives: Zarxio

Solicitor General Sides With Sandoz On Interpretation Of Biosimilar Statute

The Solicitor General of the United States has filed an amicus brief in Sandoz Inc. v. Amgen Inc., asking the Supreme Court to grant certiorari and reverse the Federal Circuit’s interpretation of one of the “patent dance” provisions of the biosimilar statute. In particular, the Solicitor General does not agree that the pre-marketing notice required … Continue reading this entry

Federal Circuit Finds Biosimilar Patent Dispute Resolution Procedures Optional

In Amgen v. Sandoz, a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that appears to favor biosimilar applicants over owners of original biologic products (“reference product sponsors”). The court held that a biosimilar applicant does not have to share its biosimilar application with … Continue reading this entry