Extrapolation is used to support the approval of a proposed biosimilar product in one or more additional indications for which the reference product is licensed, but for which the biosimilar has not been studied in clinical trials.1

Extrapolation has the potential to reduce or eliminate the need to study a proposed biosimilar with clinical trials in every indication of the reference product. But it is not an automatic process. It is based on all available data in the biosimilar application and a regulatory body like FDA’s previous findings of safety and efficacy of the reference product’s approved indications.1


  1. USFDA. Scientific considerations in demonstrating biosimilarity to a reference product. 2015