US FDA Releases Draft Guidances for Biosimilars
18 April 2012
The Biologics Price Competition and Innovation Act ("BPCI Act"), enacted as part of the Affordable Care Act on March 23, 2010, is intended to create an abbreviated approval pathway for biological products that can be demonstrated to be biosimilar to, or interchangeable with, a biological products previously approved by the FDA (called "reference" products). Under the BPCI Act, a proposed biological product that is demonstrated to be biosimilar to the reference drug can rely on existing scientific knowledge about the safety, purity, and potency of the reference product to support licensure through the streamlined approval pathway.
The FDA has now issued draft guidance documents describing its requirements for biosimilarity (but not for interchangeability).