News
FDA approves Biooviz, a Lucentis biosimilar.
Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the FDA has approved Biooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab)i for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).
Ranibizumab is an anti-vascular endothelial growth factor (VEGF) therapy that prevents vision loss in patients with retinal vascular disorders which can cause irreversible blindness or visual impairments in adults in the United States . Byooviz is the first ophthalmology biosimilar approved in the United States.
The U.S. patents for Lucentis and Eylea will expire this year 2021, and their European patents will expire in 2022 and 2025, respectively, according to Sharma et. al. Eylea also comes off patent in 2022 in China and Japan.
Condition: AMD/RVO/mCNV
Type: drug