RWD30 Adverse Event Reporting of Marketed Biosimilar and Biological Monoclonal Antibody Cancer Treatments in the United States

Abstract

By September 8, 2022, 10 biological monoclonal antibody (mAb) biosimilar products for cancer treatment had been approved and marketed in the United States (U.S.). These biosimilars were approved based on bioequivalence studies conducted among healthy volunteers, but their post-marketing investigations for safety are limited. This research aims to examine adverse event (AE) reporting patterns and disproportionate reporting signals for mAb biosimilars in the U.S. compared to their originator biologics.