Systematic Review Supports Safety, Efficacy of One‐Time Switching Between Reference and Biosimilar Infliximab

March 2, 2019

Biosimilars Team

Although the available evidence generally supports the safety and efficacy of one‐time switching between reference and biosimilar infliximab in inflammatory disorders, higher quality data based on the performance of multiple‐switch studies are needed to validate the concept of interchangeability, according to a systematic review published in the January 2019 issue of Alimentary Pharmacology & Therapeutics.

The review included 36 articles and 34 abstracts with data regarding the efficacy, safety, or immunogenicity specifically surrounding an infliximab switch. A total of 13 publications presented results from six randomized controlled trials; all were single-transition studies. The majority of the publications (53 publications) were observational studies describing a single transition from reference to biosimilar infliximab, and most (50 publications) had no concurrent control arm. The remaining publications were case series/reports. No data were available for a multiple‐switch scenario or switches between biosimilars.

The authors concluded that while the evidence revealed no clinically important efficacy or safety signals associated with switching, the overall quality of the evidence is weak, and there are insufficient data to perform a meaningful meta‐analysis at this time. Additional data are needed to explore potential switching risks in various populations and scenarios.


Feagan BG, Lam G, Ma C, et al. Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab. Aliment Pharmacol Ther. 2019 Jan;49(1):31-40. doi: 10.1111/apt.14997. Epub 2018 Nov 8.