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Biological (large molecule) drug products are made via living systems and are complex and variable in nature.  As a result, generic forms of biological products, also termed biosimilars in the EU or follow-on biologics by US FDA, can only be similar to the reference product, unlike generic versions of small molecule drug products that contain the exact same active ingredient as the brand-name drug.  Compared with small molecule drug products, more stringent assessment of safety, purity, and potency is needed to show that a follow-on biologic is not clinically different from the reference biological product.  This paper addresses statistical criteria for establishing biosimilarity and interchangeability of follow-on biologics as set forth by the Biologics Price Competition and Innovation Act.  It also highlights the scientific issues regarding the assessment of follow-on biologics that are currently still unresolved within the US

Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act