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Clinical Practice Update

Switching between biologics and biosimilars in inflammatory bowel disease (IBD)

Get an overview of biosimilars, their manufacturing process, the FDA approval process, and the data available describing their safety and efficacy for Crohn's disease and ulcerative colitis.
Find the latest clinical guidance, education, patient resources and more in our Crohn's disease toolkit.

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Summary

It is anticipated that biosimilars for inflammatory bowel disease (IBD) are here to stay. Additional biosimilars to infliximab and to adalimumab, as well as other monoclonal antibodies used in the treatment of IBD, are under development. Provided that the regulatory pathway remains rigorous and postmarketing surveillance is performed adequately, clinicians and patients can be reassured that these agents will provide the same well-described effectiveness for moderate-to-severe Crohn’s disease and ulcerative colitis without new safety concerns. Future work will require additional understanding of the real-world challenges of transitioning and potential delays due to communications or appropriate supply lines. In addition, there remains an educational gap to be filled regarding how clinicians understand these agents and making sure that, while involved in their recertification and administration, recognize the cross-reactivity of antidrug antibodies.

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