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

Overview

Journal Crohns Colitis 360

Publisher Oxford University Press

Date 2023 Feb 13

PMID 36776664

Authors

Jimmy K Limdi

Francis A Farraye

Affiliations

Soon will be listed here.

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.

Citing Articles

An Update on Anti-TNF Biosimilar Switching-Real-World Clinical Effectiveness and Safety.

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Monitoring a Mandatory Nonmedical Switching Policy from Originator to Biosimilar Infliximab in Patients with Inflammatory Bowel Diseases: A Population-Based Cohort Study.

Fisher A, Kim J, Dormuth C Gastroenterol Res Pract. 2023; 2023:2794220.

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There Is No Substitute for Effective Education About Biosimilars.

Maltz R, McNicol M, Wingate L, Buchanan S, Sandell A, Kim S Crohns Colitis 360. 2023; 3(4):otab047.

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