FTC Announces Agenda for Workshop Examining Competition Issues Surrounding Biologic and Follow-on Biologic Medicines: Biosimilars and Interchangeables

For Your Information: 12/04/2013

The Federal Trade Commission has announced the agenda for the upcoming public roundtable on “Follow-on Biologics: Impact of Recent Legislative and Regulatory Naming Proposals on Competition.” The workshop will be held in the FTC Conference Center at 601 New Jersey Ave., N.W., in Washington, DC, on December 10, 2013.

FTC Chairwoman Edith Ramirez will provide welcoming remarks at 8:30 a.m. to open the workshop. Her remarks will be followed by presentations from a wide range of experts in the research, development, commercialization and sale of biosimilar and interchangeable follow-on biologic medicines. Biologic medicines comprise the fastest-growing sector of pharmaceuticals and target such difficult-to-treat diseases as cancer, diabetes, and multiple sclerosis.

Follow-on biologics include both biosimilars and interchangeable biologic products. Recent federal legislation created an abbreviated licensure pathway for two kinds of follow-on biologics: 1) biosimilars, and 2) interchangeable biologic products. As discussed in more detail in the Federal Register notice for the workshop, the federal law establishes that interchangeable biologics “may be substituted for the reference biologic without the intervention of the health care provider who prescribed the reference product.”  The federal law does not address substitution of non-interchangeable biosimilars.

The FTC will conduct the workshop as a moderated roundtable discussion organized into two panels that will discuss: 1) how state regulations may impact competition of follow-on biologics; and 2) how naming conventions may impact competition of follow-on biologics.

The FTC’s Workshop on Follow-on Biologics 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 event. The FTC has moved the venue from its Headquarters to the FTC Conference Center, to accommodate additional attendees. The Conference Center is at 601 New Jersey Ave., NW, Washington, DC.

Further details are available in the Federal Register notice and on the workshop’s webpage. It will also be webcast on the FTC’s site. In addition, any interested person may submit written comments to any of the topics addressed during the workshops. The FTC is accepting public comments on the topics addressed in workshop through March 1, 2014. FTC staff will live-tweet the workshop. Follow @FTC and tweet your questions with #FTCfob.

The FTC’s Bureau of Competition works with the Bureau of Economics to investigate alleged anticompetitive business practices and, when appropriate, recommends that the Commission take law enforcement action. To inform the Bureau about particular business practices, call 202-326-3300, send an e-mail to antitrust{at}ftc{dot}gov, or write to the Office of Policy and Coordination, Bureau of Competition, Federal Trade Commission, 601 New Jersey Ave., Room 7117, Washington, DC 20001. To learn more about the Bureau of Competition, read Competition Counts. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.

MEDIA CONTACT:

Mitchell J. Katz, Office of Public Affairs 202-326-2161