Updates
April 1, 2015

Late last week, the U.S. Food and Drug Agency (FDA) dismissed a citizen petition filed by Amgen, Inc. asking the agency to require that biosimilar applicants provide the reference product sponsor with a copy of their application and information on their manufacturing processes.

This is now the second high-profile decision on the side of biosimilars, as the FDA's interpretation of the disputed provisions of the BPCIA is consistent with the decision of the Northern District Court of California, currently under appeal to the Federal Circuit. Although not binding on the appeal process in the on-going litigation between Amgen and Sandoz, the FDA's interpretation of the disputed provisions of the BPCIA is consistent with the trial court's earlier decision and may have persuasive weight.

To read the full alert, click here.