FDA To Host Public Hearing Regarding Approved Pathway for Biologics

The FDA will host a 2 day public hearing on November 2-3, 2010 between 8:30 am and 4:30 pm regarding the approval pathway for biological products that are highly similar (biosimilar) to or interchangeable with an FDA-licensed biological product. The hearing will seek input from the public regarding the implementation of theBiologics Price Competition and Innovation Act of 2009. The Federal Register Notice detailing the topics for the hearing can be found in the above pdf link "FR Notice". The hearing will take place at the FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31, Room 1503, Silver Spring, Maryland 20993.

The hearing will also be webcast for those unable to attend. The webcast can be accessed via the following links:

November 2, 2010: https://collaboration.fda.gov/part15day1/
November 3, 2010: https://collaboration.fda.gov/part15day2/

Resources

• Biologics Price Competition and Innovation Act
• FR Notice
• FDA White Oak Campus Map