Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition

The  Federal Trade Commission announces it will hold a workshop to explore  competition issues involving biologic medicines and follow-on biologics. As  described in the Federal Register Notice, the workshop will focus on a few key  issues, inter alia:

• The potential impact of state regulations affecting competition.
• How regulations, if necessary, might be structured to facilitate competition  while still protecting patient health and safety.
•   How naming may affect competition.
• The experience of other countries with follow-on biologic competition.

The  Federal Register 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.

Previous Biologics Workshops and Report:

• Nov. 2008 Roundtable: Competition Issues Involving Follow-on Biologic Drugs
• June 2009 Report: Follow-on Biologic Drug Competition