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Background Therapeutic drug monitoring of adalimumab (ADM) is increasingly used to optimise the management of patients with inflammatory bowel disease. The recent settlements with Abbvie concerning Humira®, paved the way for biosimilar drugs to enter the European market. In this study, we aimed to validate two commercial assays, the RIDASCREEN® ADM Monitoring (ELISA; also known as the apDia Adalimumab ELISA) and the RIDA®QUICK ADM Monitoring (rapid assay), which were developed and validated using the originator drug, for the quantification of two ADM biosimilars, AMGEVITA® and Imraldi®. Methods To validate the RIDASCREEN® ADM Monitoring, accuracy and recovery were determined by diluting AMGEVITA® and Imraldi® to varying concentrations within the clinical measuring range and in comparison with Humira®. The specification of accuracy is met when the deviation of the measured ADM biosimilar value is within ±15% of the theoretical value. For the recovery, the deviation of the measured ADM biosimilar value has to be within ± 15% of the Humira® value. To validate the RIDA®QUICK ADM Monitoring for the quantification of AMGEVITA® and Imraldi®, the recovery and linearity was determined. The recovery was determined by spiking three samples containing a low concentration of ADM biosimilar with varying concentrations of ADM biosimilar. The rapid assay complies with the requirements of recovery, if the observed value of ADM biosimilar is within ± 20% of the expected value of ADM biosimilar. The linearity was performed on the basis of NCCLS-guideline EP6-A; a sample with high concentration of ADM biosimilar was diluted 1:1 to 1:38.4. All samples were measured in the ELISA and rapid assay following manufacturer’s instructions. Results In the RIDASCREEN® ADM Monitoring, the mean deviation of the measured AMGEVITA® and Imraldi® value vs. the theoretical value was −6.6% and 2.1%, respectively. Recovery of spiked AMGEVITA® and Imraldi® samples in serum revealed a maximum absolute deviation of 12.9% and 14.8% vs. Humira®. In the RIDA®QUICK ADM Monitoring, the mean recovery of three serum samples spiked with varying concentration of AMGEVITA® and Imraldi® ranged from 91% to 115%, and 95% to 101%, respectively. Linearity was shown for both AMGEVITA® and Imraldi®. Conclusion We successfully validated the biosimilars AMGEVITA® and Imraldi® in the RIDASCREEN® ADM Monitoring and RIDA®QUICK ADM Monitoring. These results encourage therapeutic drug monitoring of ADM biosimilars in routine clinical practice.

P694 Validation of two commercial assays for therapeutic drug monitoring of adalimumab biosimilars