Bill > HR6478

This bill, the Biosimilars Competition Act of 2018, aims to enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products. The key provisions of the bill require biosimilar product applicants and reference product sponsors, as well as agreements between biosimilar product applicants, to file their agreements with the Department of Justice and Federal Trade Commission. The bill also provides for civil penalties and equitable relief for violations of these filing requirements, and authorizes rulemaking by the Federal Trade Commission to define terms and exempt certain agreements from the requirements. The overall goal is to increase transparency and oversight of agreements related to biosimilar products to ensure fair competition.