The Great Debate With IBD Biosimilars: Pro: Biosimilars Should Be Routinely Used as a First Line Biologic and May Be Switched From Reference Biologics.

Authors :: Limdi JK
Farraye FA
Source :: Crohn's & colitis 360 [Crohns Colitis 360] 2021 Apr 15; Vol. 3 (3), pp. otab015. Date of Electronic Publication: 2021 Apr 15 (Print Publication: 2021).
Publication Year :: 2021
Abstract: The relatively high cost of anti-TNF agents and looming or actual expiry of patents for several biologics have led to the development of "highly similar" versions of the "originator" drugs called "biosimilars." The approval of biosimilars has been based on "extrapolation," whereby approval is granted in licensed indications for the reference product without the need for clinical trials. We discuss efficacy and safety data in support of biosimilar use from prospective studies, switching from originator biologic, impact on immunogenicity, pharmaco-economic, and practical considerations for clinicians.<br /> (© The Author(s) 2021. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

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