ARTICLE | Company News
Trump signs law intended to deter 'pay-for-delay' deals for biosimilars
October 19, 2018 5:46 PM UTC
President Donald Trump signed the Patient Right to Know Drug Prices Act (S.2554) into law on Oct. 10, which includes a provision to make it more difficult for branded drugmakers to strike “pay-for-delay” deals with biologic and biosimilar companies.
The language aims to modernize reporting requirements for biologics and biosimilars by requiring patent settlements with branded drugmakers to be submitted to the U.S. Department of Justice and Federal Trade Commission (FTC). Previously, such reporting was only required for deals between generic and branded drugmakers. The reporting requirements are part of an effort to block “pay-for-delay” settlements, in which a branded drugmaker pays a generics company to delay the launch of its generic...