June 19, 2024

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Biosimilar approval ushers in new era in retinal medical treatment

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September 27, 2021

1 min read

Singh is a staff surgeon at the Cole Eye Institute, Cleveland Clinic and Associate Professor of Ophthalmology at the Lerner College of Medicine in Cleveland Ohio. He also currently serves as the medical director of informatics at the Cleveland Clinic.

Disclosures: Singh reports having financial interests with Alcon, Apellis, AsclepiX, Genentech, Gyroscope, NGM, Novartis and Regeneron.

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Samsung Bioepis and Biogen’s collaboration on the approval of Byooviz, a biosimilar referencing Lucentis, ushers in a new period of biosimilar anti-VEGF biologics in retina and more choices for both patients and physicians.

Rishi P. Singh

In the recent clinical trial comparing monthly Byooviz (ranibizumab-nuna) and Lucentis (ranibizumab, Genentech), the mean gain in visual acuity, improvement in anatomy and overall safety were comparable. In my previous blog post, I was critical of the trial designs being studied by some companies when trying to derive equivalence in the two agents. Samsung and Biogen have conducted a study that can truly show equivalence with the dosing regimen employed.

We should be cautious at this point as we have not seen all of the secondary endpoints involved with this study. In addition, because ranibizumab is not the leading market agent for anti-VEGF treatment, the impact on the market as a whole might be limited. And there is much more to come as there are many anti-VEGFs, including Lucentis, Avastin (bevacizumab, Genentech) and Eylea (aflibercept, Regeneron), nearing the end of patent protection and biosimilars in studies pending.