FDA has announced that it will conduct a two-day hearing for stakeholders to provide input on agency's implementation of the Biologics Price Competition and Innovation Act 2009 (BPCI).The BPCI 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.”

Scheduled for November 2-3, 2010, the hearing is designed to gather public input on issues such as (i) “scientific and technical factors related to a determination of biosimilarity or interchangeability,” (ii) “the type of information that may be used to support a determination of biosimilarity or interchangeability, (iii) “development of a framework for optimal pharmacovigilance for biosimilar and interchangeable biological products,” (iv) “scope of the revised definition of a ‘biological product,’” (v) “priorities for guidance development,” (vi) “scientific and technical factors related to reference product exclusivity,” (vii) “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 (viii) “the establishment of a user fee program for biosimilar and interchangeable biological products.” See The Hill, September 20, 2010; FDA News & Events, October 4, 2010; Federal Register, October 5, 2010.