Federal Trade Commission November 15, 2013 – Federal Register Recent Federal Regulation Documents

The Federal Trade Commission (``FTC'' or ``Commission'') announces it will hold a workshop to explore competition issues involving biologic medicines and follow-on biologics. The workshop will focus on the potential impact of state regulations and naming conventions on such competition, including how regulations may be structured to facilitate competition while still protecting patient health and safety. The experience of developing follow-on competition from small-molecule generic drugs will be considered and, as relevant, compared. Topics will include the circumstances under which potential entrants would be willing to invest in the development of follow-on biologics in order to use the abbreviated regulatory approval pathway created by federal legislation. The workshop will also survey the experience of other countries with regulatory systems that enable follow-on biologic competition. This Notice poses a series of questions about which the FTC seeks public comment. The FTC will take these comments into account in its examination of these topics.