Report: FDA hearing to discuss biosimilar regulations

WASHINGTON The Food and Drug Administration is looking for input on regulations concerning knock-off versions of biotech drugs, according to published reports.


The Hill, a newspaper in Washington, reported Monday that the FDA would have a hearing on Nov. 2 and 3 concerning follow-on biologics, based on a draft document distributed to healthcare lobbyists.



According to the report, the hearing would focus on such issues as interchangeability and definitions of such terms as “biological product.”