McDonnell Boehnen Hulbert & Berghoff LLP partner Kevin E. Noonan, Ph.D., authored an article entitled, “FDA Acts on Biosimilars” that appears in the June 24, 2015 online edition of BIOTechNOW. In The Biologics Price Competition and Innovation Act (BPCIA) deferred to the Food and Drug Administration with regard to implementing the particulars of how the biosimilar approval pathway would be implemented. The U.S. Food and Drug Administration has issued a series of draft Guidances indicating how it was considering implementing the biosimilar approval pathway contained in the Act. The Guidances were expressly “draft” in nature, and were the subject of public hearings with the Agency welcoming industry input. View the article