Details
In this analysis, we performed signal identification for selected infliximab biosimilars (infliximab-abda, infliximab-axxq, and intravenous (IV) infliximab-dyyb) by monitoring non-pregnancy, non-cancer, and non-trauma outcomes among new users of these products in the Sentinel Distributed Database (SDD). We conducted this signal identification assessment using an active comparator, new user design to identify incident safety outcomes following initiation of selected infliximab biosimilar products (BPs) compared to the reference infliximab product (RP) using Tree-Only Scan analyses among individuals 18 years of age and older. A sensitivity analysis for one BP (infliximab-dyyb) included individuals six years of age and older with evidence of Crohn’s disease.
The study period includes data from January 1, 2017 to May 31, 2025. We distributed this request to six Sentinel Data Partners on December 24, 2025.
Statistical alerts generated by this analysis do not on their own represent safety signals. Alerts are triaged in consideration of the study design, existing drug knowledge, therapeutic context, treated population, and potential public health impact. Alerts determined to be newly identified safety signals (NISS) follow the FDA’s Center for Drug Evaluation and Research manual of policies and procedures for NISS (MAPP 4121.3).
The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.