Measuring biosimilar levels

Mar 22, 2016 - E-Mentoring in IBD | Volume 9 • 2016

Issue 06

Clinical Question

Does an assay for measuring Remicade also measure infliximab biosimilars, Remsima and Inflectra.

Editor’s Bottom Line

An assay that detects Remicade will also detect infliximab biosimilars, Remsima and Inflectra.

Reference

Gils A, Van Stappen T, Dreesen E, et al. Harmonization of infliximab and anti-infliximab assays facilitates the comparison between originators and biosimilars in clinical samples. Inflamm Bowel Dis. 2016 Mar 7. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/26954707

Synopsis

To test the reactivity of antibodies of both Remicade and its biosimilars (Remsima and Inflectra), a panel of 55 mouse monoclonal antibodies were raised against Remicade (MA-IFX). These 55 and the validated MA-IFX10F9 and MA-IFX6B7 were then tested by sandwich ELISAs coated with each biologic (Remicade, Remsima and Inflectra) and dose-response curves were generated.

Serum of 36 patients treated with Remicade was then analyzed for anti-infliximab antibodies to Remicade, Remsima and Inflectra using their respective bridging ELISA.

The infliximab ELISA quantified Remsima and Inflectra equally well as Remicade. Anti-Remicade antibodies detect antibodies to Remsima and Inflectra.

Details

Study Design: Retrospective study
Funding: Fund for Scientific Research Flanders
Allocation: n/a
Setting: Belgium
Level of Evidence: 2b (Oxford Levels of Evidence)

The summary and conclusion in this issue of E-mentoring in IBD pertains to the manuscript(s) being reviewed, and should be considered in the context of what is already known surrounding the topic and incorporated into practice as deemed appropriate by the individual learner.