Ocular Risks of Adalimumab Biosimilars Through a National Analysis

Document Type

Conference Proceeding

Publication Date

6-2026

Publication Title

Investigative Ophthalmology and Visual Science

Abstract

Purpose : Many studies comparing adalimumab biosimilars and reference product (RP) adalimumab safety for specific indications exist. However, a comprehensive, real-world safety profile comparison between adalimumab biosimilars and RP adalimumab remains needed.
We performed a retrospective pharmacovigilance study to evaluate comparative safety of adalimumab biosimilars and RP adalimumab using the FDA Adverse Event Reporting System (FAERS), testing for any adverse events (AEs) with disproportionate reporting among adalimumab biosimilars.

Methods : We analysed AE reports of RP adalimumab and its ten approved biosimilars from FAERS between 2021 to 2025. We performed deduplication, case expansion, and classification into original (adalimumab) and biosimilar (adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm adalimumab-afzb, adalimumab-aqvh, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp, and adalimumab-ryvk). We performed hypothesis testing with calculation of reporting odds ratio (ROR), proportional reporting ratio (PRR), chi-squared with Yates’ correction (χ2), empirical Bayes geometric mean (EBGM), and information component (IC). We considered a signal detected when all metrics were positive with at least five cases in the biosimilar group.

Results : We included 13,939 biosimilar cases and 199,080 original cases. From 142 AEs meeting all signal criteria (ASC), the most common included incorrect drug administration rate (n=1900 biosimilar cases, 13.6%), near medication error (n=1411, 10.1%), and product dispensing issues (n=1001, 7.2%). Of the five eye disorders meeting ASC, conjunctival haemorrhage demonstrated the strongest positive signal (ROR 95% CI: 12.25 [4.12-36.45], PRR = 12.24, χ2 = 27.19, EBGM [EBGM05]: 6.52 [2.89], IC [IC05]: 2.27 [1.44]), followed by periorbital swelling (ROR 95% CI: 7.15 [3.99-12.80], PRR = 7.14, χ2 = 55.57, EBGM [EBGM05]: 5.00 [3.20], IC [IC05]: 2.19 [1.63]) and abnormal eye sensation (ROR 95% CI: 7.14 [2.68-19.04], PRR = 7.14, χ2 = 16.97, EBGM [EBGM05]: 4.85 [2.14], IC [IC05]: 1.95 [1.04]).

Conclusions :
Our study identified five eye disorders associated with adalimumab biosimilar usage. Patients using adalimumab biosimilars should be counselled accordingly. Further research is warranted to explore causality and underlying mechanisms in these associations.

Volume

67

Issue

7

First Page

OD194

Comments

Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, May 3-7, 2026, Denver, CO

Last Page

OD194

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