The Federal Trade Commission (FTC) is seeking public comment on follow-on biologics.
- Press Release (November 8, 2013)
- Federal Register Notice (November 8, 2013)
- Filing a Public Comment (Deadline March 1, 2014)
In addition, the FTC will hold a public workshop on December 1oth.
The 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:
December 10, 2013 Time: 9am – 5pm
601 New Jersey Avenue, NW