First Biosimilar to Lucentis Gets FDA Approval

The Food and Drug Administration has approved Byooviz (ranibizumab-nuna) as the first biosimilar product to Lucentis (ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Byooviz is a vascular endothelial growth factor inhibitor. Based on a totality of evidence, the FDA determined that there were no clinically meaningful differences between the biosimilar product and the reference product. The efficacy, safety, pharmacokinetics, and immunogenicity of Byooviz were compared with Lucentis in a phase 3 trial that included 705 patients with neovascular age-related macular degeneration (ClinicalTrials.gov Identifier: NCT03150589).

At week 52, results showed a least squares (LS) mean change in best corrected visual acuity from baseline of 9.79 letters in the Byooviz arm vs 10.41 letters in the Lucentis arm (difference: -0.62; 90% CI, -2.092, 0.857). The LS mean change in central subfield thickness was observed to be -139.55μm for Byooviz and -124.46μm for Lucentis (difference: -15.09; 95% CI, -25.617, -4.563). The safety and immunogenicity profile of Byooviz was found to be comparable to Lucentis at all timepoints.

“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,” said Ian Henshaw, Senior Vice President and Global Head of Biosimilars at Biogen. “Biosimilars could help broaden patient access to more affordable treatments and generate healthcare savings to offset rising costs of these complex diseases while ensuring sustainability of healthcare systems.”

Byooviz is supplied as a single-dose glass vial designed to deliver 0.05mL of 10mg/mL ranibizumab-nuna solution for intravitreal injection. The product is expected to be available in the US in June 2022.

References

1. FDA approves first biosimilar to treat macular degeneration disease and other eye conditions. News release. US Food and Drug Administration. Accessed September 20, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treat-macular-degeneration-disease-and-other-eye-conditions. 
2. FDA approves Samsung Bioepis and Biogen’s Byooviz™ (SB11), Lucentis® biosimilar (ranibizumab-nuna). News release. Biogen Inc. Accessed September 20, 2021. https://www.globenewswire.com/news-release/2021/09/20/2299684/0/en/FDA-Approves-Samsung-Bioepis-and-Biogen-s-BYOOVIZ-SB11-LUCENTIS-Biosimilar-ranibizumab-nuna.html.
3. Byooviz. Package insert. Biogen Inc.; 2021. Accessed September 20, 2021. https://www.biogencdn.com/us/biosimilars/sb11-pi.pdf.