FDA has released three final guidance documents on biosimilars but left for later its regulatory answers on requirements for demonstrating interchangeability of a biosimilar with a reference product and terms for establishing the exclusivity period for pioneer biologics. FDA will address these issues in a separate draft guidance. The agency does not have an estimated timeline for when the document will be released.
The agency released final guidances covering scientific and quality considerations in demonstrating biosimilarity. The document on scientific considerations includes additional information on study design, endpoint selection and appropriate patient populations for a comparative clinical trial. The guidance also clarifies what factors to consider when assessing whether products are highly similar, including expression system, manufacturing process, impurities, reference product and reference standards.
The agency also issued a guidance providing questions and answers on biosimilars, which explain how sponsors can justify extrapolation from a single indication to support approval for additional indications on a reference product's label. The document indicates that sponsors should avoid extrapolation from indications for which the reference product has obtained accelerated approval but has not yet demonstrated clinical benefit in post-marketing trials.
The Q&A also includes FDA's expectations for the submission of pediatric study plans and outlines justification that should be provided by a sponsor to use comparative data with a non-U.S.-licensed product to support an application to FDA.
