Details
The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System to conduct untargeted safety signal identification for infliximab biosimilar products (BPs) compared to the reference product, Remicade. Although biosimilars have no clinically meaningful differences from their reference product and studies support the safety of switching, concerns persist among prescribers and patients. The infliximab BPs included in the study and the reference product are currently approved for Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. The FDA initiated one active comparator, new-user analysis in Sentinel involving ten assessments using a tree-based scan statistic to support safety signal identification for infliximab BPs.
The goal of the study was to proactively monitor for new or unexpected non-pregnancy, non-cancer, and non-trauma outcomes among new users of infliximab BPs.
After evaluating the statistical alerts generated by this study in the context of other information, the FDA did not identify any new safety concerns and determined that no further evaluation is warranted at this time. Statistical 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). Overall, the study did not identify any new safety concerns for infliximab BPs in this sample of real-world new users.