Samsung Bioepis and Biogen on Monday announced that the FDA approved Byooviz (ranibizumab-nuna), a biosimilar referencing Roche's VEGF therapy Lucentis (ranibizumab), to treat neovascular age-related macular degeneration (AMD), macular oedema following retinal vein occlusion (RVO) and myopic choroidal neovascularisation (mCNV). The decision makes Byooviz the first ophthalmology biosimilar approved in the country, and follows recent regulatory nods in the EU and UK.
"This approval represents a great step toward the advancement of a new therapeutic option addressing debilitating disease progression of patients with retinal vascular disorders in the US," remarked Ian Henshaw, global head of biosimilars at Biogen.
According to the companies, the FDA approval of Byooviz, also known as SB11, was based on a "totality of evidence," including a Phase III study that analysed 634 patients with wet AMD randomised to receive monthly injections of Byooviz or reference Lucentis. The trial met its primary endpoints, defined as changes from baseline in best-corrected visual acuity (BCVA) at week eight and central subfield thickness at week four. Secondary goals looked at long-term efficacy, safety, pharmacokinetics and immunogenicity, which were also comparable between the two treatments.
The biosimilar product will be allowed to be marketed in the US starting June 2022, as part of an agreement with Roche's Genentech unit, and before the expiration of supplementary patent certificates (SPCs) held by Genentech. Biogen will be responsible for commercialisation.
Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research, said "continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs." The agency has so far approved 31 biosimilars.
Meanwhile, Samsung Bioepis and Biogen will be able to launch Byooviz in other territories after the expiration of Genentech's SPCs. Aside from Byooviz, Samsung Bioepis and Biogen's partnership agreement also covers the ophthalmology biosimilar candidate SB15, which references Regeneron Pharmaceuticals' Eylea (aflibercept).
Lucentis, which Roche co-markets with Novartis, brought in sales of CHF 1.4 billion ($1.5 billion) in 2020. Novartis also markets the injectable VEGF inhibitor Beovu (brolucizumab) to treat wet AMD in the US, where it was approved in 2019. Meanwhile, US and EU regulators are also reviewing Roche's application for faricimab to treat wet AMD and diabetic macular oedema. If approved, Roche says faricimab, which targets both VEGF-A and Ang-2, would be the first bispecific antibody designed for the eye and could extend treatment to every four months.
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