Background: Infliximab (IFX) has changed the management of many life-threatening immune-mediated diseases.\nThe high cost of IFX and its patent expiry have led to pharmaceutical companies developing a biosimilar; however,\nits safety profile remains unknown in the real world. The purpose of this study was to clarify the adverse events\nassociated with IFX originator and its biosimilar using the Japanese Adverse Drug Event Report (JADER) database.\nMethods: Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency between the third\nquarter of 2014 and the fourth quarter of 2018. We calculated the reporting odds ratio and 95% confidence interval\nfor each adverse event.\nResults: We obtained 2771 reports of adverse events associated with IFX originator and 402 reports with IFX biosimilar.\nSignals were detected for pneumonia, interstitial lung disease, tuberculosis, and sepsis with both IFX originator and its\nbiosimilar, whereas there was no signal for infection with the biosimilar.\nConclusions: The strength of the association between IFX originator and its biosimilar with adverse events is partly\ndifferent, but reports were quite limited for the biosimilar compared with originator. It is recommended that research\nbe continued in order to accumulate a wide variety of information, and that newly reported data be placed in the\nmultifaceted viewpoints for improvement of care levels.
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