Biogen Inc. and Samsung Bioepis Co. Ltd. announced that BYOOVIZ™ (ranibizumab-nuna), a biosimilar referencing LUCENTIS® (ranibizumab)i has been launched in the United States. Healthcare provider engagement, promotional activity, collaborations with professional societies and patient advocacy groups have commenced and BYOOVIZ will be commercially available on July 1, 2022, through major distributors across the U.S. The list price will be $1,130 per single use vial to administer 0.5mg via intravitreal injection, which is 40% lower than the current list price of LUCENTIS.

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. Neovascular (wet) AMD, although less common than dry AMD, is responsible for the majority of the severe vision loss or blindness associated with AMD.ii Anti-VEGF therapies have become a standard of care treatment for wet AMD, but in real-world settings, costs related with wet AMD treatment often raise challenges in achieving optimal clinical outcomes.iii Biosimilars, which are biologics with similar efficacy and comparable safety to reference biologics,iv have the potential to alleviate the financial burden associated with current anti-VEGF therapies. BYOOVIZ is the first biosimilar launch in the U.S. under the Biogen and Samsung Bioepis' partnership.

In addition to the U.S., BYOOVIZ was also approved as the first ophthalmology biosimilar in Europe (2021), the United Kingdom (2021), and Canada (2022). The Biogen and Samsung Bioepis commercialization agreement includes two ophthalmology biosimilar candidates, BYOOVIZ and SB15, a biosimilar candidate referencing EYLEA® (aflibercept)v. Samsung Bioepis is responsible for development, regulatory registration, and manufacture of the products, while Biogen is responsible for commercialization. About BYOOVIZ™ (ranibizumab-nuna): BYOOVIZ™ (ranibizumab-nuna) injection, for intravitreal use; BYOOVIZ™ (ranibizumab-nuna) is biosimilar to LUCENTIS® (ranibizumab injection); BYOOVIZ™, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD); Macular Edema Following Retinal Vein Occlusion (RVO); and Myopic Choroidal Neovascularization (mCNV).

Select Important Safety Information - WARNING AND PRECAUTIONS: Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection; Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection; and There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.