As defined by section 351(k) of the Public Health Service (PHS)
Act, a biosimilar product is highly similar to its reference product,
“notwithstanding minor diff erences in clinically inactive
components.” The US Food and Drug Administration (FDA)
recommends taking a progressive, “stepwise” approach when
developing data needed to demonstrate biosimilarity. Meg Egan
Auderset, Medical & Regulatory Writer, Clarivate Analytics,
discusses why clinical pharmacology studies form part of the FDA’s
approach.