Commission Announces Agenda for Roundtable on Follow-on Biologic Drugs

The Federal Trade Commission has announced the agenda for the upcoming public roundtable on “Follow-on Biologic Drugs: Framework for Competition and Continued Innovation.” The roundtable will be held in Room 432 at FTC Headquarters in Washington, DC, on November 21, 2008.

FTC Commissioner Pamela Jones Harbour will provide welcoming remarks to open the roundtable at 8:30 a.m. These remarks will be followed by opening remarks by Rachel Behrman of the U.S. Food and Drug Administration (FDA) at 8:45 a.m. on the subject of “How Do Biologic Drugs Differ from Small Molecule Drugs?”

The FTC will conduct the workshop as a moderated roundtable discussion organized into five panels that will discuss the following issues: the price and market share effect of entry by both biosimilar and biogeneric drugs, the likely competitive effects of reference product regulatory exclusivity, biotechnology patent issues, the likely competitive effects of follow-on biologic regulatory incentives, and the patent resolution process. The agenda and more information about the workshop are at: http://www.ftc.gov/bc/workshops/hcbio/index.shtml.

In addition, any interested person may submit written comments to any of the topics addressed during the workshops. Comments directed at a particular subject considered during the roundtable must be received no later than December 22, 2008.

The FTC’s Roundtable on Follow-on Biologic Drugs is free and open to the public. No pre-registration is required, but all attendees must present a valid photo ID for admission to
the Headquarters building, which is located at 6th Street and Pennsylvania Avenue, N.W., Washington, DC.

The workshop will be accessible to people with disabilities. Anyone needing a related accommodation should contact Carrie McGlothlin at the FTC at 202-326-3388 or cmcglothlin@ftc.gov. Such requests should include a detailed description of the accommodations needed and contact information if more information is needed. Please provide advance notice of accommodation needs.

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 1,500 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s Web site provides free information on a variety of consumer topics.

(Biologics Workshop.final.wpd)