Effectiveness and Safety Outcomes After Switching from Reference Biologics to Biosimilars for Treatment of Non-Infectious Uveitis: A Systematic Review and Meta-Analysis.
7 affiliations
- 1Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.
- 2Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
- 3Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
- 4Division of Ophthalmology, McMaster University, Hamilton, ON, Canada.
- 5Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada.
- 6Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
- 7HollandBone and Joint Research Program, Sunnybrook Research Institute, Toronto, ON, Canada.
Abstract
This study aims to compare the effectiveness and safety of switch from reference biologics to their biosimilars in the treatment of non-infectious uveitis (NIU). A literature search was conducted in Ovid MEDLINE, Ovid EMBASE and Cochrane Central Register of Controlled Trials, Scopus, and Web of Science from inception until October 2024 (PROSPERO protocol #: CRD42021283386). Eligible studies involving any age groups with NIU treated with any biosimilar or reference biologic were included. Risk of bias and certainty of evidence were evaluated using ROBINS-I and GRADE, respectively, and random-effects meta-analyses were conducted using the Mantel-Haenszel method. A total of 11 studies, including 343 patients with NIU, met the inclusion criteria. Most studies were retrospective before-and-after designs and were assessed as having a serious risk of bias, largely due to confounding. The relative risk of recurrence for biosimilars was 0.98 (95% CI: 0.55-1.72); final logMAR visual acuity was comparable between biosimilar and reference biologic groups (mean difference, -0.0116; -0.0983 to 0.0751). For safety outcomes, the risk ratios for ophthalmic, minor systemic, and major systemic adverse events were 1.02 (0.30-3.45), 1.24 (0.72-2.14), and 1.99 (0.67-5.87), respectively. The risk ratios for drug discontinuation due to lack of effectiveness and adverse events were 2.44 (0.80-7.45) and 1.56 (0.79-8.31), respectively. Most included studies were assessed as having a "serious" risk of bias, largely driven by confounding, and the overall certainty of evidence was graded as "low". Currently, the available evidence is of low quality and demonstrates insufficient support for a meaningful difference in terms of effectiveness and safety when switching patients with NIU to biosimilars from their reference biologics.
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BibTeX
@article{felfeli2026effectiveness,
title = {{Effectiveness and Safety Outcomes After Switching from Reference Biologics to Biosimilars for Treatment of Non-Infectious Uveitis: A Systematic Review and Meta-Analysis.}},
author = {Tina Felfeli and Natalie Kozlowski and Felicia Tai and Jorge R Georgakopoulos and Jihad Waked and Sherif El-Defrawy and Laura C Rosella and Jessica Widdifield and Rafael N Miranda},
journal = {Clinical ophthalmology (Auckland, N.Z.)},
year = {2026},
month = nov,
doi = {10.2147/opth.s606642},
url = {https://europepmc.org/article/MED/42999825},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Effectiveness and Safety Outcomes After Switching from Reference Biologics to Biosimilars for Treatment of Non-Infectious Uveitis: A Systematic Review and Meta-Analysis.
AU - Tina Felfeli
AU - Natalie Kozlowski
AU - Felicia Tai
AU - Jorge R Georgakopoulos
AU - Jihad Waked
AU - Sherif El-Defrawy
AU - Laura C Rosella
AU - Jessica Widdifield
AU - Rafael N Miranda
PY - 2026
DA - 2026/11/03
JO - Clinical ophthalmology (Auckland, N.Z.)
DO - 10.2147/opth.s606642
UR - https://europepmc.org/article/MED/42999825
AB - This study aims to compare the effectiveness and safety of switch from reference biologics to their biosimilars in the treatment of non-infectious uveitis (NIU). A literature search was conducted in Ovid MEDLINE, Ovid EMBASE and Cochrane Central Register of Controlled Trials, Scopus, and Web of Science from inception until October 2024 (PROSPERO protocol #: CRD42021283386). Eligible studies involving any age groups with NIU treated with any biosimilar or reference biologic were included. Risk of bias and certainty of evidence were evaluated using ROBINS-I and GRADE, respectively, and random-effects meta-analyses were conducted using the Mantel-Haenszel method. A total of 11 studies, including 343 patients with NIU, met the inclusion criteria. Most studies were retrospective before-and-after designs and were assessed as having a serious risk of bias, largely due to confounding. The relative risk of recurrence for biosimilars was 0.98 (95% CI: 0.55-1.72); final logMAR visual acuity was comparable between biosimilar and reference biologic groups (mean difference, -0.0116; -0.0983 to 0.0751). For safety outcomes, the risk ratios for ophthalmic, minor systemic, and major systemic adverse events were 1.02 (0.30-3.45), 1.24 (0.72-2.14), and 1.99 (0.67-5.87), respectively. The risk ratios for drug discontinuation due to lack of effectiveness and adverse events were 2.44 (0.80-7.45) and 1.56 (0.79-8.31), respectively. Most included studies were assessed as having a "serious" risk of bias, largely driven by confounding, and the overall certainty of evidence was graded as "low". Currently, the available evidence is of low quality and demonstrates insufficient support for a meaningful difference in terms of effectiveness and safety when switching patients with NIU to biosimilars from their reference biologics.
SN - 1177-5467
SN - 1177-5483
ER -