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Cochrane Corner: Anti-vascular endothelial growth factor biosimilar for macular degeneration

Eye (2024)Cite this article

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Neovascular age-related macular degeneration (nAMD) is the advanced form of AMD, affecting 20% of patients but causing irreversible vision loss in more than 80% of AMD patients [1, 2]. Intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents have been shown to successfully preserve or improve visual acuity for at least one year [3]. However, uncertainty in the injection frequency and the overall treatment duration beyond 12–24 months has imposed tremendous time and financial burden to patients and their families due to the need for continual monitoring and follow-up visits [4].

Biosimilars are biological products that have chemical structure and biological function comparable to previously patented anti-VEGF agents (the reference drug) [5]. Due to their much-reduced prices, biosimilars provide a greater accessibility than the reference drug to patients with nAMD, especially in the middle- and low-income countries [6]. Biosimilar development relies on a comprehensive head-to-head comparison of the biosimilar and the reference drug. The European Medicine Agency (EMA) conceives comparability as a stepwise process that is tailor-made for each product, with the aim of ruling out differences in clinical efficacy or safety between the biosimilar and the reference drug. The US Food and Drug Administration (FDA) approves biosimilars through an abbreviated pathway [7]. FDA may also approve a biosimilar for an indication (or a specific population) without requiring direct evidence from new trials when safety and efficacy have been confirmed for the original indication. Moreover, switching studies are typically conducted to achieve interchangeability with the original reference drug [8]. Despite these rigorous requirements by regulatory agencies [9,10,11], physicians and patients still have concerns about the clinical equivalence of biosimilars to the reference drug. Increased risks of intraocular infection and inflammation are particularly concerning [12].

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Funding

Funding

SL reported a grant UG1EY020522 from the National Eye Institute, National Institutes of Health, USA; payment to institution. GV reported none.

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Authors and Affiliations

  1. Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA

    Su-Hsun Liu

  2. Department of Epidemiology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA

    Su-Hsun Liu

  3. IRCCS-Fondazione Bietti, Rome, Italy

    Gianni Virgili

  4. Dipartimento Neurofarba, University of Florence, Florence, Italy

    Gianni Virgili

Authors
  1. Su-Hsun Liu
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  2. Gianni Virgili
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Both authors contributed to the article concept, manuscript preparation, and revision.

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Correspondence to Gianni Virgili.

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Liu, SH., Virgili, G. Cochrane Corner: Anti-vascular endothelial growth factor biosimilar for macular degeneration. Eye (2024). https://doi.org/10.1038/s41433-024-03263-2

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