McDonnell Boehnen Hulbert & Berghoff LLP partners Dr. Kevin E. Noonan and Dr. Andrew W. Williams co-authored an article entitled, “First U.S. Biosimilar Application Approved — But What About the Patent Issues?” that appears in the March 31, 2015 online edition of iBIO’s Biological Quarterly. After a seemingly interminable delay (certainly for policymakers who were hoping for a “quick fix” with regard to biologic drug prices), the first biosimilar application was accepted and, in short order, approved by the Food and Drug Administration. And almost concurrently, a U.S. District Court denied Amgen’s motion for a preliminary injunction, thereby clearing the way for the drug to be put on the market (albeit now without risk of patent infringement liability). View the article