Tag Archives: Enbrel

Amgen Launches Enbrel Biosimilar Patent Litigation

Although Sandoz’ application for FDA approval to market a biosimilar version of ENBREL® (etanercept) has yet to be approved, Amgen has brought suit under the Patent Act and Biologics Price Competition and Innovation Act (BPCIA) to enforce five patents relating to that product and approved methods of use. Some of the BPCIA issues raised in … Continue reading this entry

Federal Circuit Finds No Biosimilars Application Means No Case Or Controversy For Sandoz

In Sandoz Inc. v. Amgen Inc., the Federal Circuit upheld the district court decision dismissing Sandoz’s declaratory judgment action for lack of jurisdiction. Although this may be the first Federal Circuit decision relating to a possible “biosimilar” product, the court was careful to steer clear of the biosimilars statute. Apparently the judges aren’t the only … Continue reading this entry