An in vitro comparison of four different immunoassays for the monitoring of Infliximab biosimilars drug levels.

BACKGROUND

SB2 (Renflexis®, Merck) and CT-P13 (Inflectra®, Pfizer) are biosimilars of the reference Infliximab (Remicade®, Janssen) and are approved in Canada for use in indications for which Infliximab is approved, including inflammatory bowel disease. These biosimilars are structurally different but exhibit comparable physicochemical characteristics, pharmaceutical effectiveness and immunogenicity compared to Infliximab. Optimal Infliximab therapy currently relies on therapeutic drug monitoring offered by several reference laboratories.

OBJECTIVE

Because the appropriate dosing depends on accurate determination of drug levels and anti-drug antibodies, the ability of current Infliximab assays to measure the biosimilars and corresponding antibodies needs to be demonstrated.

METHODS

The correlation between Infliximab and the biosimilars measured with four different enzyme-linked immunosorbent assays for Infliximab detection was evaluated. Spiked serum samples were assayed with kits from (A) Immunodiagnostik/ALPCO Diagnostics, (B) R-Biopharm, (C) Theradiag and (D) Progenika Biopharma. The impact of various concentrations of antibodies to Infliximab on the quantification of biosimilars was also tested.

RESULTS

A good correlation of SB2, CT-P13 and reference Infliximab spiked serum samples was observed with the four assays. The observed bias between the original drug and biosimilars is clinically insignificant and less than the usual analytical variability observed with these methods. The quantification of the biosimilars and Infliximab was equally impacted in serums containing antibodies to Infliximab. The recovery of the drugs was inversely correlated with the concentration of anti-Infliximab antibodies, suggesting common immunodominant epitopes for SB2, CT-P13 and Infliximab.

CONCLUSION

The ability of these assays to properly quantify the biosimilars Renflexis® and Inflectra® has been demonstrated. The therapeutic drug monitoring required for Infliximab therapy can be adequately performed with the biosimilars using the kits currently in use or available in clinical laboratories.