Comparative Safety Analysis of Avastin and Bevacizumab Biosimilars Based on Food and Drug Administration Adverse Event Reporting System

Objective

This study aimed to compare adverse event (AE) profiles between Avastin and bevacizumab biosimilars to support clinical decision-making, given the limited availability of real-world data.

Methods

A disproportionality analysis was conducted using the FDA Adverse Event Reporting System (FAERS) to identify and compare AE signals. Signals were evaluated at the system organ classes (SOCs) and preferred term (PT) levels, focusing on the Top 20 PTs by report number, key SOCs and outcomes.

Results

Injury, poisoning and procedural complications and general disorders and administration site conditions were the most frequent SOCs in both groups. Common label-listed AEs, including hypertension, proteinuria and thrombocytopenia, were frequently reported. Shared risks also included gastrointestinal perforation/ulceration and thromboembolism. Avastin was more associated with red blood cell disorders and ureteric disorders and bladder and bladder-neck disorders, while biosimilars were linked to a broader range of high-level group terms in gastrointestinal disorders and generated more renal and urinary signals.

Conclusion

Hypertension, proteinuria, thrombocytopenia, gastrointestinal perforation and thromboembolism remain key concerns. Clinicians should monitor renal and urinary function when administering Avastin. Immune-induced renal disorders associated with biosimilars highlight the importance of assessing the treatment rationale in patients with chronic kidney disease, autoimmune disorders or other comorbid conditions.