MBHB Partner Kevin Noonan Authors Article Entitled, “What’s in a Name: The FDA Tries to Decide Regarding Biosimilars”

McDonnell Boehnen Hulbert & Berghoff LLP partner Dr. Kevin E. Noonan authored an article entitled, “What’s in a Name: The FDA Tries to Decide Regarding Biosimilars” that appears in the online edition of Pharmaceutical Compliance Monitor on December 23, 2015. When Congress passed the Biologic Price Competition and Innovation Act (BPCIA) in 2009 it left to the Food and Drug Administration (FDA) the task of implementing the provisions of the Act within the scope of its agency expertise. One of these tasks is deciding whether the same or different nonproprietary names (a name assigned by the U.S. Adopted Names Council (USAN) for both small molecule and biologic drugs) would be given to a biosimilar version of an innovator’s biologic drug (or reference product, to use the Act’s terminology). Innovator biologic drug makers argued that the name of the biosimilar should be distinguishable, so as not to produce confusion between the reference product and one or more biosimilars. Companies interested in making biosimilars argued that having different names would impede adoption of the biosimilar and frustrate Congressional intent to have a robust biosimilar regime. View the article