Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting

The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” (biosimilar) to, or “interchangeable” with, an FDA-licensed biological product. The purpose of this public hearing is to create a forum for interested stakeholders to provide input regarding the agency’s implementation of the statute. FDA will take the information it obtains from the public hearing into account in its implementation of the BPCI Act.

Date(s):    November 2-3, 2010

Time:        8:30 a.m. to 4:30 p.m.

Location:    FDA White Oak Campus
                 10903 New Hampshire Ave, Building 31, Room 1503
                 Silver Spring, Maryland 20993

• Federal Register Notice
• Agenda (PDF - 36KB)
• Panel Members (PDF - 18KB)
• Transcript: Tuesday, November 2, 2010 (PDF - 4MB)
• Transcript: Wednesday, November 3, 2010 (PDF - 647KB)

Visitor Information

All meeting attendees must enter through Building 1 on the FDA White Oak Campus. Parking is available in the Southeast surface lot and a shuttle bus will be available to bring attendees from the lot to Building 1.  Please see Directions/Transportation/Parking/Hotels for the FDA White Oak Campus (PDF - 115KB) for directions and further details about transportation and lodging. Map of White Oak Visitor Parking (PDF - 105KB)

Webcast of Meeting
For those unable to attend in person, the meeting will also be webcast.  Watch the webcast on November 2 and November 3 from 8:30 am to 4:30 pm.  Requirements and instructions for accessing the webcast are below.

You may access the webcast via these links:

• November 2 - https://collaboration.fda.gov/part15day1/
• November 3 - https://collaboration.fda.gov/part15day2/

Meeting Recording

• Part 15 Public Mtg - Day 1
• Part 15 Public Mtg - Day 2

Adobe Connect Minimum Requirements:

• View meetings on Windows, Macs, Unix, and Linux platforms
• Lan or Broadband internet connection
• Supports Internet Explorer, Firefox, Safari, Netscape Navigator, AOL
• Adobe Flash Player (no other downloads needed)
• VPN and Parachute compatible but not required
• Test my computer for Adobe Connect-Readiness

Attendance and Registration to Speak:

The FDA Conference Center at the White Oak location is a federal facility with limited seating so attendance will be on a first come-first served basis. 

Individuals who wish to speak must register by sending an e-mail to biosimilarspublicmtg@fda.hhs.gov on or before October 11, 2010 and provide complete contact information for each speaker, including name, title, affiliation, address, e-mail, and phone number.  FDA will do its best to accommodate requests to speak and will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin.

If you need special accommodations because of disability, please contact Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, phone (301)796-1042, e-mail biosimilarspublicmtg@fda.hhs.gov at least 7 days before the meeting.