In a recent publication in Expert Opinion on Biological Therapy, researchers examined adverse event (AE) reporting patterns for monoclonal antibody (mAb) biosimilars in the United States compared with their originator/reference biologics. They also examined disproportionate reporting signals for these mAb biosimilars, defined as a statistical association between a medication and adverse events.

The study employed the U.S. Food and Drug Adverse Event Reporting System database to find AE reports for biological rituximab, bevacizumab, trastuzumab, and their marketed biosimilars. To gather data from these reports, researchers examined data based on patient age, gender, and type of reporters of AEs and then calculated the percentages of each category.

To compare reporting disproportionality in serious, death, and specific AEs between mAb biologics/biosimilars (index) and all other drugs, reporting odds ratios (RORs) with 95% CIs were calculated. Moreover, the Breslow-Day statistic was employed to establish consistency in RORs between each mAb biologic/biosimilar pair at P <.05.

The authors indicated that no risk signals of serious or death AE were reported for all three mAb biosimilars, and a signal of disproportionate reporting of mortality was observed between biologic and biosimilar bevacizumab (P <.05).

In conclusion, the authors wrote, "Our findings support the similarity in signals of disproportionate AE reporting between mAb originator biologics and biosimilars, except for death between biological and biosimilar bevacizumab."

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