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former FTC Conference Center
601 New Jersey Avenue, NW Washington DC 20001

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Event Description

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:

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In Oct. 2015, FTC staff filed a comment with the U.S. Food and Drug Administration in response to the FDA’s draft guidance addressing nonproprietary names for biological products. The staff comment expresses concern that the FDA draft guidance on biosimilar naming may hinder competition, and recommends that the agency consider alternatives.

  • Request for Comments

    The last day to submit public comments was March 1, 2014.

FTC Privacy Policy

Under the Freedom of Information Act (“FOIA”) or other laws, we may be required to disclose to outside organizations the information you provide when you pre-register for events that require registration. The Commission will consider all timely and responsive public comments, whether filed in paper or electronic form, and as a matter of discretion, we make every effort to remove home contact information for individuals from the public comments before posting them on the FTC website.

The FTC Act and other laws we administer permit the collection of your pre-registration contact information and the comments you file to consider and use in this proceeding as appropriate. For additional information, including routine uses permitted by the Privacy Act, see the Commission’s Privacy Act system for public records and comprehensive privacy policy.

This event will be open to the public and may be photographed, videotaped, webcast, or otherwise recorded.  By participating in this event, you are agreeing that your image — and anything you say or submit — may be posted indefinitely at ftc.gov or on one of the Commission's publicly available social media sites.

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