FDA OKs Samsung Bioepis, Biogen BYOOVIZ™ (SB11), LUCENTIS® Biosimilar

 

• BYOOVIZ™ becomes the first ophthalmology biosimilar to gain FDA approval in the United States

Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has approved BYOOVIZ™ (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 (US).ii,iii,iv,v

BYOOVIZ™ is the first ophthalmology biosimilar approved in the United States. Biosimilars are products that have been demonstrated to be similar in efficacy and safety to the originator’s reference product, with the advantage that they offer cost savings and promote sustainable access to therapies.vi Savings in the United States over the next five years from 2020 to 2024 as a result of biosimilars are projected to exceed $100 billion.vii

https://finance.yahoo.com/news/fda-approves-samsung-bioepis-biogen-113000322.html