The U.S. Food and Drug Administration will be holding a two-day public hearing to obtain input on specifi c issues and challenges associated with implementation of the Biologics Price Competition and Innovation Act of 2009 (the BPCI Act). The BPCI Act, which was signed into law on March 23, 2010, establishes an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” (biosimilar) to, or “interchangeable” with, an FDA-licensed biological. The hearing, to be held November 2-3, 2010, will be the fi rst public hearing on the Act conducted by the FDA since it became law. According to the FDA, the purpose of the 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.
The hearing details are as follows:
WHAT: Public hearing regarding the BPCI Act
WHEN: November 2 & 3, 2010; 8:30 a.m. to 4:30 p.m.
WHERE: FDA’s White Oak Campus, 10903 New Hampshire Ave. Building 31, Room 1503, Silver Spring, MD 20993
Electronic or written comments will be accepted by the FDA after the public hearing until December 31, 2010. Also, a live webcast of the public hearing will be viewable on the days of the hearing at the following Web address: http://www.fda.gov/Drugs/NewsEvents/ ucm221688.htm. Transcripts of the public hearing will be available for review approximately 30 days after the public hearing at the Division of Dockets Management and on the Internet at: http://www.regulations.gov.
For further details on the hearing, see Federal Register Vol. 75, No. 92, Tuesday, October 5, 2010.