The Food and Drug Administration is wrestling with how to best implement the Biologics Price Competition and Innovation Act. The agency is writing regulations that will set the exact rules for gaining biosimilar approval and has scheduled a meeting to obtain public input on the regulatory pathway that is being considered. The meeting is set for November 2-3 and will be held at FDA’s facility in Silver Spring, Maryland. The full meeting announcement can be found here. A live webcast of the 2-day event can be found here.
A quick look at some of the issues the FDA wants input on during the hearing shows how different biosimilars are from traditional generic regulation. Besides those discussed below, the FDA is seeking comment on a variety of marketing, technical and regulatory issues. The breadth and depth of all these questions speak to the complexities of the issues that are being dealt with. Given the uncertainty surrounding pending decisions and their impact on companies seeking to enter the biosimilar market, I believe the first U.S. biosimilar will not to be approved for at least two years.






