Applying a comparative effectiveness framework to evaluate perinatal outcomes of biosimilar versus originator biologic disease-modifying antirheumatic drugs

Managing rheumatic disease during pregnancy is challenging. Biosimilar medications, which are lower-cost versions of biologic drugs, have been shown in early studies to work as well and be as safe as the original versions. However, little is known about their effects on pregnancy outcomes. This study will examine how often biologic originators and biosimilars are used before and during pregnancy, and whether women continue or stop these treatments. I will then compare the risks of complications in mothers and babies between those using biosimilars and those using biologic originators. To do this, I will analyze provincial health data in British Columbia, including the perinatal registry of births and other health system records. The findings will provide much-needed up-to-date evidence on the safety of these medications in pregnancy, help guide treatment decisions for women planning families, and support cost-effective prescribing. Results will be translated to diverse knowledge through manuscripts, conference presentations, and patient-engaged outputs (lay summaries, visuals, presentations to the Arthritis Patient Research Advisory Board).