{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T10:25:27Z","timestamp":1774347927482,"version":"3.50.1"},"reference-count":37,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,8,27]],"date-time":"2025-08-27T00:00:00Z","timestamp":1756252800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,8,27]],"date-time":"2025-08-27T00:00:00Z","timestamp":1756252800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Basic Clin Pharma Tox"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study aimed to compare adverse event (AE) profiles between Avastin and bevacizumab biosimilars to support clinical decision\u2010making, given the limited availability of real\u2010world data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Injury, poisoning and procedural complications and general disorders and administration site conditions were the most frequent SOCs in both groups. Common label\u2010listed 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\u2010neck disorders, while biosimilars were linked to a broader range of high\u2010level group terms in gastrointestinal disorders and generated more renal and urinary signals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Hypertension, proteinuria, thrombocytopenia, gastrointestinal perforation and thromboembolism remain key concerns. Clinicians should monitor renal and urinary function when administering Avastin. Immune\u2010induced 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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bcpt.70099","type":"journal-article","created":{"date-parts":[[2025,8,28]],"date-time":"2025-08-28T03:40:03Z","timestamp":1756352403000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Comparative Safety Analysis of Avastin and Bevacizumab Biosimilars Based on Food and Drug Administration Adverse Event Reporting System"],"prefix":"10.1111","volume":"137","author":[{"given":"Xiaoyu","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Equipment West China Hospital, Sichuan University  Chengdu China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yupeng","family":"Zhang","sequence":"additional","affiliation":[{"name":"Evidence\u2010Based Pharmacy Center West China Second Hospital, Sichuan University  Chengdu China"},{"name":"Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education  Chengdu China"},{"name":"West China School of Pharmacy Sichuan University  Chengdu China"},{"name":"Department of Pharmacy West China Second Hospital, Sichuan University  Chengdu China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xinghang","family":"Tang","sequence":"additional","affiliation":[{"name":"West China School of Pharmacy Sichuan University  Chengdu China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li","family":"Chen","sequence":"additional","affiliation":[{"name":"Evidence\u2010Based Pharmacy Center West China Second Hospital, Sichuan University  Chengdu China"},{"name":"Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education  Chengdu China"},{"name":"Department of Pharmacy West China Second Hospital, Sichuan University  Chengdu China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,8,27]]},"reference":[{"issue":"1","key":"e_1_2_10_2_1","doi-asserted-by":"crossref","first-page":"818","DOI":"10.2741\/1839","article-title":"VEGFR\u20101 and VEGFR\u20102: Two Non\u2010Identical Twins with a Unique Physiognomy","volume":"11","author":"Rahimi N.","year":"2006","journal-title":"Frontiers in Bioscience"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCRESAHA.108.174128"},{"key":"e_1_2_10_4_1","unstructured":"Drugs@FDA: FDA\u2010Approved Drugs [Internet] [cited 2025 Jul 16] Available from:https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm?event=BasicSearch.process."},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11523-017-0518-1"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2024.7053"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.esmoop.2022.100591"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ctrv.2020.102017"},{"key":"e_1_2_10_9_1","unstructured":"Hoffmann\u2010La Roche A Randomized Study of the Effect of Maintenance Therapy With Bevacizumab + Capecitabine Versus Bevacizumab Alone on Progression\u2010Free Survival in Patients With HER2\u2010Negative Metastatic Breast Cancer That Has Not Progressed During First\u2010line Docetaxel Plus Bevacizumab Therapy[Internet] clinicaltrials.gov; 2015 Mar [cited 2025 Jul 16]. 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