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

IF 3.3 4区医学 Q2 PHARMACOLOGY & PHARMACY

Basic & Clinical Pharmacology & Toxicology Pub Date : 2025-08-27 DOI:10.1111/bcpt.70099

Xiaoyu Zhang, Yupeng Zhang, Xinghang Tang, Li Chen

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Abstract

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.

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基于美国食品药品监督管理局不良事件报告系统的阿瓦斯汀和贝伐单抗生物类似药安全性比较分析

在现实世界数据有限的情况下，本研究旨在比较阿瓦斯汀和贝伐单抗生物类似药之间的不良事件（AE）概况，以支持临床决策。方法采用FDA不良事件报告系统（FAERS）进行歧化分析，对AE信号进行识别和比较。在系统器官类别（soc）和首选术语（PT）水平上对信号进行评估，重点关注报告编号，关键soc和结果的前20个PTs。结果损伤、中毒、手术并发症、一般疾病和给药部位情况是两组最常见的SOCs。常见的标签上列出的不良事件，包括高血压、蛋白尿和血小板减少症，经常被报道。共同的风险还包括胃肠道穿孔/溃疡和血栓栓塞。阿瓦斯汀与红细胞疾病、输尿管疾病、膀胱和膀胱颈疾病的关联更大，而生物仿制药与胃肠道疾病的更广泛的高级组术语相关，并产生更多的肾脏和泌尿信号。结论高血压、蛋白尿、血小板减少、胃肠道穿孔和血栓栓塞仍是关注的重点。临床医生在使用阿瓦斯汀时应监测肾脏和泌尿功能。与生物仿制药相关的免疫诱导肾脏疾病强调了评估慢性肾脏疾病、自身免疫性疾病或其他合并症患者治疗理由的重要性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Basic & Clinical Pharmacology & Toxicology 医学-毒理学

CiteScore

5.60

自引率

6.50%

发文量

126

审稿时长

1 months

期刊介绍： Basic & Clinical Pharmacology and Toxicology is an independent journal, publishing original scientific research in all fields of toxicology, basic and clinical pharmacology. This includes experimental animal pharmacology and toxicology and molecular (-genetic), biochemical and cellular pharmacology and toxicology. It also includes all aspects of clinical pharmacology: pharmacokinetics, pharmacodynamics, therapeutic drug monitoring, drug/drug interactions, pharmacogenetics/-genomics, pharmacoepidemiology, pharmacovigilance, pharmacoeconomics, randomized controlled clinical trials and rational pharmacotherapy. For all compounds used in the studies, the chemical constitution and composition should be known, also for natural compounds.