Imron Aly, JD, partner at Schiff Hardin LLP, discusses a recent law that will involve new regulatory oversight of biologics settlements.
What are the implications of the recently passed law to have the Federal Trade Commission (FTC) and Department of Justice (DOJ) review settlements between brand manufacturers and biosimilar developers?
Having the DOJ and the FTC review settlements is the norm already in the small-molecules world, so it won’t be anything unexpected or different for the biologics world. As a policy it’s been enforced quite strictly; in fact, since that policy had taken place for small molecules there’s been over 12 challenges by the FTC against individual settlements.
So, there’s been a very aggressive tack. I will add on here at the P4 conference this year an FTC representative came to speak and she explained that the FTC will be continuing to be aggressive in all settlement enforcements for anything of value and just a launch date, and I expect that the same will stay true for biologics.