Biosimilars: Totality of the Evidence in Biosimilar Development

In the totality-of-the-evidence approach, FDA considers all the available evidence needed to make a regulatory decision about a proposed product’s biosimilarity to the licensed reference product. This video provides an overview on the totality-of-the-evidence approach used by FDA to ensure that a proposed product meets the rigorous approval standards for biosimilarity. For more information, visit www.FDA.gov/biosimilars.