Tree-Based Safety Signal Identification for Infliximab Biosimilar vs Reference Products

This poster describes a project that examined tree-based safety signal identification for infliximab biosimilar products compared with the infliximab reference product. This study uses the US FDA’s Sentinel System to evaluate whether any new safety concerns emerge after initiation of infliximab biosimilars in routine clinical care. It was presented at the 2026 ISPE Annual Meeting.