Biogen and Samsung Bioepis have announced the US launch of 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 (VEGF) inhibitor. The efficacy, safety, pharmacokinetics, and immunogenicity of Byooviz were compared with Lucentis in a phase 3 trial (ClinicalTrials.gov Identifier: NCT03150589) that included 705 patients with neovascular age-related macular degeneration. Results from the study showed no clinically meaningful difference between the biosimilar product and the reference product.

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 will be commercially available through major distributors across the US on July 1, 2022. The list price will be $1130 per single use vial.

“The launch of Byooviz, the first ophthalmology biosimilar in the US marks a key step towards increasing options and reducing the financial burden associated with current anti-VEGF treatments,” said Christopher Hansung Ko, President and CEO, at Samsung Bioepis.

Reference

Biogen and Samsung Bioepis’ Byooviz™ (ranibizumab-nuna) launches in the United States. News release. Biogen Inc. and Samsung Bioepis Co. Accessed June 2, 2022. https://investors.biogen.com/news-releases/news-release-details/biogen-and-samsung-bioepis-byooviztm-ranibizumab-nuna-launches