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Updated: Aug 10, 2025

In Vivo Augmentation of Gut-Homing Regulatory T Cell Induction
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The Great Debate With IBD Biosimilars: Pro: Biosimilars Should Be Routinely Used as a First Line Biologic and May Be
Jimmy K Limdi1, Francis A Farraye2
1Inflammatory Bowel Diseases Section, Department of Gastroenterology, The Pennine Acute Hospitals NHS Trust, Manchester Academic Health Sciences, University of Manchester, Manchester, UK.
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.
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