Sandoz’s  Biosimilar Zarxio Marketplace Entry Delayed

Patients will need to wait for Zarxio,the biosimilar of Amgen’s cancer treatment Neupogen. Zarxio is the first biosimilar that was approved (March 6, 2015) in the United States under the abbreviated approval pathway of the Biologics Price Competition and Innovation Act (BPCIA).  The direct link to the federal court of appeals opinion is below.

Synopsis—In an Appeal from the United States District Court for the Northern District of California in No. 3:14-cv-04741-RS, the Federal Circuit Court of Appeals on July 21, 2015 interpreted the advance notice provision in a manner that effectively delays marketplace entry. This means that Sandoz’s release of Zarxio, its biosimilar of Amgen’s cancer treatment Neupogen, will not occur until Sept. 2. How the Court of Appeals interpreted the advance-notice provision is a significant victory for brand-name biologics.

District Court Interpretation—The district court had determined that the statute only required it to provide notice 180 days before it commercially marketed the biosimilar and that Sandoz had given Amgen such notice on July 14, 2014, when it filed its biosimilar application with the FDA.

Federal Court of Appeals Interpretation—Yet, the federal court of appeals, determined that notice of a biosimilar must be given to the biologic brand reference product sponsor (RPS) not later than 180 days after the Food and Drug Administration approves/licenses the biosimilar. The court of appeals stated: “We agree with Amgen that, under paragraph (l)(8)(A), a subsection (k) applicant may only give effective notice of commercial marketing after the FDA has licensed its product. That is,the Appeals Court determined that based on the language in the BPCIA, notice be provided after the biosimilar product is licensed by the FDA.

The direct link to the official Federal Circuit opinion is: Amgen, Inc. v. Sandoz, Inc.