Public Workshop: FDA/FTC Workshop on a Competitive Marketplace for Biosimilars March 9, 2020

Meeting | Mixed

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• Date: March 9, 2020
• Time: 9:00 a.m. - 5:00 p.m. ET
• Location: White Oak Campus: The Great Room; Conference Center; 10903 New Hampshire Ave; Building 31, Room 1503; Silver Spring, MD 20993; United States

• Organized By: Office of New Drugs

The Food and Drug Administration (FDA), in collaboration with the Federal Trade Commission (FTC), is announcing a public workshop on March 9, 2020, "FDA/FTC Workshop on a Competitive Marketplace for Biosimilars."  The purpose of the public workshop is to discuss FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and deter anticompetitive behaviors in the biologic marketplace. 

The entrance for public meeting participants (non-FDA employees or contractors) is through Building 1, where routine security check procedures will be performed. For parking, security and other visitor information, please refer to Public Meetings at the FDA White Oak Campus.

Registration

Please use Eventbrite to register for in-person or webcast attendance.

Background Information

• Federal Register Notice
• Meeting Agenda (PDF)
• Public Comment Session Agenda (PDF)
• Speaker Bios (PDF)
• Meeting Transcript (PDF)

If you need special accommodations due to a disability, please contact Sandra Benton at 301-796-1042 or sandra.benton@fda.hhs.gov at least 7 days before the workshop.

Webcast Recording

FDA FTC Workshop for Biosimilars
https://collaboration.fda.gov/pm6x8nmgcmj5/
https://collaboration.fda.gov/puzlrb7hy9qk/
https://collaboration.fda.gov/py2n67jp4yjt/
https://collaboration.fda.gov/pc2puqouweg7/

Public Docket

In addition to providing input at the public workshop, stakeholders are invited to submit electronic or written comments to the public docket. Please review the Federal Register notice for information on submitting comments.  The public docket will close on April 9, 2020. 

Requests for Oral Presentations

For those interested in participating as an Open Public Workshop speaker, please register at Eventbrite as “In-person Open Public Workshop presenter.”  Open Public Workshop registrations are due by February 24, 2020; however, if time is available, you may sign up as an Open Public Workshop speaker the day of the meeting.  Time and space are limited and available on a first-come, first-served basis.  Open Public Workshop speakers may be assigned no more than 5 minutes for their presentation and will deliver oral testimony only (no accompanying slide deck).  No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

Questions

Office of Therapeutic Biologics and Biosimilars
Office of New Drugs
Center for Drug Evaluation and Research
CDER-BiologicsBiosimilarsInquiries@fda.hhs.gov

FDA/FTC Workshop Summary Report

FDA and FTC drafted this summary report of the workshop to capture the discussion at the meeting. This report reflects discussions, presentations, and docket submissions made in conjunction with the March 2020 public workshop and reflects the factual context that existed at that time.

Summary Report on the FDA/FTC Workshop on a Competitive Marketplace for Biosimilars (PDF - 2.68 MB)

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Event Materials

Title	File Type/Size
FDA/FTC Workshop on a Competitive Marketplace Agenda	pdf (138.44 KB)
Public Comment Session Agenda 03092020 meeting	pdf (89.55 KB)
Speaker Bios 03092020 meeting	pdf (176.66 KB)
Meeting Transcript 03092020	pdf (737.69 KB)
Summary Report Biosimilars Workshop	pdf (2.68 MB)