The performance of Remicade®-optimized quantification assays in the assessment of Flixabi® levels.

ABSTRACT:

Background

The advent of Remicade® biosimilars, Remsima®, Inflectra® and, more recently, Flixabi®, has brought along the potential to decrease the costs associated with this therapy, therefore increasing its access to a larger group of patients. However, and in order to assure a soft transition, one must make sure the assays and algorithms previously developed and optimized for Remicade perform equally well with its biosimilars. This study aimed to: (a) validate the utilization of Remicade-optimized therapeutic drug monitoring assays for the quantification of Flixabi; and (b) determine the existence of Remicade, Remsima and Flixabi cross-immunogenicity.

Methods

Healthy donors' sera spiked with Remicade, Remsima and Flixabi were quantified using three different Remicade-quant

SUBMITTER: Magro F 

PROVIDER: S-EPMC6153527 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature