Venable Fitzpatrick partner Ha Kung Wong discussed with the Center for Biosimilars recent regulatory actions to promote biosimilars, including the recent FDA/FTC collaboration to fight anticompetitive practices for biosimilars, and the March 23, 2020 transition of regulation of certain small molecule drugs, including insulins, to regulation as biologics. He addressed the questions:
- Will manufacturers be motivated to bring products to market under the newly established biologics approval pathway under the Biologics Price Competition and Innovation Act?
- Is it possible that the newly announced FDA/Federal Trade Commission (FTC) collaboration to fight anticompetitive practices will improve the marketplace for biosimilars?
View the article by the Center for Biosimilars with his comments here.