Orange Book Blog

The Federal Trade Commission is hosting a roundtable entitled "Competition Issues Involving Follow-On Biologic Drugs," Friday, November 21, at its headquarters in Washington.  Speakers include industry leaders, government officials, outside counsel and others.

The agenda includes the following presentations:

• Welcoming remarks, FTC Commissioner Pamela Jones Harbour
• Opening remarks, Rachel Behrman, FDA: "How Do Biologic Drugs Differ from Small Molecule Drugs?"
• "Likely Market Effects of Follow-On Biologic Drug Competition," a panel discussion moderated by Michael Wroblewski and Elizabeth Jex, FTC
• "Likely Competitive Effects of Reference Product Regulatory Exclusivity," moderated by Michael Wroblewski and Christopher Garmon, FTC
• "Biotechnology Patent Issues," moderated by Suzanne Michel and Suzanne Drennon, FTC
• "Likely Competitive Effects of Follow-On Biologic Regulatory Incentives," moderated by Michael Wroblewski and Elizabeth Jex, FTC
• "Patent Dispute Resolution Processes," moderated by Michael Wroblewski and Suzanne Drennon, FTC

In advance of the roundtable, over a dozen organizations have submitted comments to the FTC, including BIO, GPhA, and PhRMA.

A live webcast of the event will be offered.  For more information, please visit the FTC website.