Ziv-aflibercept for Better Regulating Neovascular Age-Related Macular Degeneration (ZEBRA): A Prospective, Randomized Trial

D'Souza, Haley; Kapoor, Kapil; Wagner, Alan

doi:10.1080/08820538.2021.1884269

Cited by 1 publication

(1 citation statement)

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“…Bevacizumab appears generally non-inferior to ranibizumab and aflibercept in neovascular agerelated macular degeneration (nAMD) and diabetic macular edema (DME), although a recent trial in retinal vein occlusion (RVO) could not conclude that bevacizumab was non-inferior to aflibercept [33][34][35][36]. Also, ziv-aflibercept, an anti-VEGF drug approved for treating colorectal cancer, has been investigated as a treatment for nAMD [37], despite the fact that in the EU intravitreal use of ziv-aflibercept is contraindicated because of its hyperosmotic properties [38]. In addition to their off-labeldriven limitations, both products require additional compounding prior to use in retinal diseases, which may increase the risk of intraocular infections [39][40][41][42].…”

Section: What Role May Biosimilars Play In the Ophthalmology Space?mentioning

confidence: 99%

An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review

et al. 2022

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Biological therapies have revolutionized the treatment of disease across a number of therapeutic areas including retinal diseases. However, on occasion, such treatments may be relatively more expensive compared to small molecule therapies. This can restrict patient access and treatment length leading to suboptimal clinical outcomes. Several biosimilar candidates of ranibizumab and aflibercept are currently in development and the first biosimilar of ranibizumab received EMA approval in August and FDA approval in September 2021. Biosimilars are biological medicines that are highly similar to an already-approved biological medicine (reference product). The physicochemical and clinical similarity of a biosimilar is determined by a rigorous analytical and clinical program, including extensive pharmacokinetic and pharmacodynamic analysis with phase III equivalence studies where appropriate. These phase III studies are carried out in a patient population that is representative of all of the potential approved therapeutic indications of the originator product and the most sensitive for detecting potential differences between the biosimilar and the reference product. Biosimilars have been used successfully across a wide range of therapeutic areas for the past 15 years where they have achieved substantial cost savings that can be reinvested into healthcare systems without affecting the quality of patient care. The current review provides an introduction to biosimilars with the aim of preparing retinal specialists for discussing these products with their patients.

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Section: What Role May Biosimilars Play In the Ophthalmology Space?mentioning

confidence: 99%

An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review

et al. 2022

View full text Add to dashboard Cite

show abstract

Ziv-aflibercept for Better Regulating Neovascular Age-Related Macular Degeneration (ZEBRA): A Prospective, Randomized Trial

Cited by 1 publication

References 50 publications

An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review

An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review

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