FDA approves first biosimilar to Roche’s blockbuster ophthalmology drug Lucentis

Byooviz becomes the first ophthalmology biosimilar to be approved by the Food and Drug Administration.



The FDA has given the greenlight to Byooviz (ranibizumab-nuna) – the first ophthalmology biosimilar to approved by the agency as well as the first FDA-approved biosimilar referencing Roche’s blockbuster drug Lucentis (ranibizumab). The regulatory nod clears Byooviz to be used for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization. The latest development also come just three weeks after the biosimilar was granted marketing authorization by the European Commission. The biosimilar which is developed by Samsung Bioepis will be marketed by Biogen in the U.S. However, patients will need to wait until June 2022 to access the biosimilar in the U.S. due to a global licensing agreement with Genentech, a subsidiary of Roche.


At present, about 11 million Americans are said to be living with AMD. In addition, the prevalence of advanced AMD in the U.S. is increasing due to the country’s aging population. “The approval of the first ranibizumab biosimilar in the US is a monumental milestone for people living with retinal vascular disorders in the US,” said Kyung-Ah Kim, senior vice president and development division leader at Samsung Bioepis, in a press release by the Korean company and its partner Biogen. Byooviz also becomes the fourth biosimilar developed by Samsung Bioepis to be approved by the FDA. Its authorization is expected to shave off a notable share of Lucentis’ U.S. sales. For the second quarter this year alone, the blockbuster drug earned Roche $363 million in the U.S - figures that could soon be history.