The U.S. Food and Drug Administration (FDA) has issued three final guidances on biosimilars, which come shortly after approving the first biosimilar under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The first guidance addresses common questions regarding FDA implementation of the BPCIA, including exclusivity, biosimilarity, and interchangeability, and the definitions relevant to the BPCIA. The second guidance details how the FDA encourages sponsors to use a three-step approach to develop evidence necessary to establish biosimilarity. The third guidance relates to the biosimilarity of therapeutic protein products and describes detail nine factors relevant to developing analytical studies to show a proposed product is “highly similar” to a reference product. The National Law Review has a complete breakdown of the guidances here.
Last Updated on May 7, 2020 by Aimed Alliance
