Today the FDA published a notice announcing public hearings on November 2 and 3, 2010 on implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was enacted as part of the Affordable Care Act (ACA). 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 notice outlines many implementation issues on which the agency seeks stakeholder feedback. In particular, the FDA raises a series of questions in the following areas: scientific and technical factors related to a determination of biosimilarity or interchangeability; the type of information that may be used to support a determination of biosimilarity or interchangeability; development of a framework for optimal pharmacovigilance for biosimilar and interchangeable biological products; scope of the revised definition of a “biological product”; priorities for guidance development; scientific and technical factors related to reference product exclusivity; scientific and technical factors that may inform the agency’s interpretation of “product class” as it relates to available regulatory pathways for certain protein products during the 10-year transition period following enactment of the BPCI Act; and the establishment of a user fee program for biosimilar and interchangeable biological products (the FDA seeks information about particular companies and trade associations that would be potential participants in any negotiations regarding user fee programs for biosimilars). Attendance will be on a first come-first served basis, although the meeting also will be webcast. Individuals who wish to present at the public hearing must register by October 11. Electronic or written comments also will be accepted until December 31, 2010.
Home Health Care FDA to Hold Public Meeting on ACA Biosimilars Pathway – November 2-3, 2010