BYOOVIZ Launch – Big Molecule Watch

On June 2, 2022, Biogen Inc. and Samsung Bioepis Co., Ltd. announced  that BYOOVIZ™ (ranibizumab-nuna), a biosimilar referencing Genentech’s LUCENTIS®, will be available in the United States on July 1, 2022.  BYOOVIZ™ is the first FDA approved ophthalmology biosimilar.  The FDA approved BYOOVIZ™ in September 2021 for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

BYOOVIZ™ is the first biosimilar launch in the United States under the partnership between Biogen and Samsung Bioepis.  According to the press release, the Biogen and Samsung Bioepis commercialization agreement also includes SB15, a biosimilar candidate referencing EYLEA® (aflibercept), with Samsung Bioepis responsible for development, regulatory registration, and manufacture of the products, while Biogen is responsible for commercialization.