Evidence map›Paper›PMID 40867018›Full record

ArticleBasic & clinical pharmacology & toxicology2025

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

Xiaoyu Zhang, Yupeng Zhang, Xinghang Tang, Li Chen

Abstract readComparative Study
In one paragraph

Article in Basic & clinical pharmacology & toxicology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Xiaoyu ZhangDepartment of Equipment, West China Hospital, Sichuan University, Chengdu, China.
Yupeng ZhangEvidence-Based Pharmacy Center, West China Second Hospital, Sichuan University, Chengdu, China.
Xinghang TangWest China School of Pharmacy, Sichuan University, Chengdu, China.
Li ChenEvidence-Based Pharmacy Center, West China Second Hospital, Sichuan University, Chengdu, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis 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.

methodsA 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.

resultsInjury, 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.

conclusionHypertension, 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.

Indexed as

Adverse Drug Reaction Reporting SystemsAngiogenesis InhibitorsBevacizumabBiosimilar PharmaceuticalsDrug-Related Side Effects and Adverse ReactionsHumansPharmacovigilanceUnited StatesUnited States Food and Drug AdministrationAngiogenesis InhibitorsBevacizumabBiosimilar PharmaceuticalsbevacizumabbiosimilarsFAERSsafetysignal comparison

Identifiers

PMID40867018
PMCPMC12391571

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.