U.S. antitrust authority Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) signed a joint statement that they will cooperate to monitor and mitigate competition problems in biologics markets.
Biological drugs are used for the treatment of many diseases and they are more complex and advanced products compared to traditional drugs. Therefore, biological drugs face high production costs. According to the FTC assessments; practices in biologics markets delay or prevent entry into the market of biosimilar products thereby depriving patients of the benefits of competition, including lower prices and increased innovation. On the other hand, FDA considers that competition is the key for patients' access to biological drugs at affordable prices and strengthening efforts to prevent anti-competitive behavior, will decrease the prices in biologics market.
According to the joint statement; the FTC and FDA will coordinate to promote greater competition in markets for biologics and biosimilars, deter behavior that impedes access to samples needed to develop these products, take appropriate action against false or misleading communications about these products and review patent settlement agreements involving them.
In 2010 Congress enacted the Biologics Price Competition and Innovation Act to promote competition for biologics, including by biosimilars. FTC on the other hand, conducted a market inquiry on biologics published a detailed report in 2009. Additionally, FTC held a workshop in 2014 on the impact of regulations on competition in the biologics market.