Phase IV Clinical Trials of Biosimilars for Cancer: Extrapolation of the ‘Basket Concept’ of Trials

Abstract

Of late, the concept of ‘basket trials’, testing the effect of a single drug in multiple indications is receiving increased attention.[1] Can this concept be extrapolated to the clinical development of biosimilars? Majority of the regulatory agencies have the provision for the approval of biosimilars for one or more additional indications based on the concept of extrapolation without necessarily conducting trials in those indications.[2-4] Read More