S. 1414 — Expedited Access to Biosimilars Act

This section revises the clinical study requirements for FDA licensure of biosimilar biological products by (1) requiring, in addition to existing studies of analytical similarity, pharmacokinetics studies sufficient to demonstrate safety, purity, and potency; and (2) requiring clinical studies sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used. (As background, biosimilars are approved through an abbreviated pathway under the Public Health Service Act upon a showing of high similarity to a licensed reference biological product, with no clinically meaningful differences in terms of safety, purity, and potency.) It further authorizes FDA, at its discretion, to require such clinical studies to include assessments of immunogenicity, pharmacodynamics, or comparative clinical efficacy, but only if FDA provides the applicant prior notice and a written justification no later than the earliest filing date for the application. The amendments apply to biosimilar applications submitted on or after the date of enactment.