• FDA to Hold First Public Hearing on New Biosimilars Statute
  • November 4, 2010 | Author: Timothy J. Shea
  • Law Firm: Sterne, Kessler, Goldstein & Fox P.L.L.C. - Washington Office
  • 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.