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FDA Hepatitis Update - Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting Nov. 2-3



Title: FDA Hepatitis Update - Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting Nov. 2-3
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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

Summary information and directions available at:

Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting

The complete Federal Register Notice is available at:

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:

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@xxxxxxxxxxx at least 7 days before the meeting.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration


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