Published on:September 2018
    Journal of Pharmacy Practice and Community Medicine, 2018; 4(3):131
    Guest Editorial | doi:10.5530/jppcm.2018.3.31

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

    Authors and affiliation (s):

    Jayesh Bhatt*, Manjunath Krishnappa, Deven Parmar

    Cadila Healthcare Ltd., Zydus Research Centre, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, INDIA.


    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

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