The Federal Trade Commission held a workshop to explore competition issues involving biologic medicines and follow-on biologics. As described in the Federal Register Notice, the workshop focused 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.
Webcast and Transcript
The workshop webcast videos are available for viewing (under Video, below). Viewers may want to review the panelist slide presentations (under Event Speakers, below) as they watch the videos. A transcript of the workshop is available as well (under Transcript, below).
Previous Biologics Workshops and Report:
- Nov. 2008 Roundtable: Competition Issues Involving Follow-on Biologic Drugs
- June 2009 Report: Follow-on Biologic Drug Competition
Subsequent Work on Biologics:
In Oct. 2015, FTC staff filed a comment with the U.S. Food and Drug Administration in response to the FDA’s draft guidance addressing nonproprietary names for biological products. The staff comment expresses concern that the FDA draft guidance on biosimilar naming may hinder competition, and recommends that the agency consider alternatives.
Transcript - Files
VideosFollow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition - Part 1Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition - Part 2Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition - Part 3Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition - Part 4
Request for Comments
The last day to submit public comments was March 1, 2014.