By Kevin E. Noonan — In September, the U.S. Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry," and Draft Guidance entitled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)." The Final Guidance provides its Answers in final form, having been subject to the notice and comment requirements for FDA Guidances and originally promulgated as Questions and Answers on Biosimilar Development and the BPCI Act (April 2015) and New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)…
