FDA Clears First Biosimilar to Lucentis

The drug won't be available till next year but is expected to dent sales of Roche's blockbuster for age-related macular degeneration and other eye diseases.

FDA approved the first biosimilar to Roche’s blockbuster drug Lucentis for neovascular (wet) age-related macular degeneration (AMD) and other eye diseases today. The federal regulatory agency cleared Byooviz (ranibizumab-nuna), to treat AMD, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Byooviz is the first ophthalmology biosimilar approved in the U.S, but it won’t be available in the U.S. till June 2022 because of a global licensing agreement with Genentech, which is part of Roche. The Lucentis biosimilar was developed by Samsung Bioepis, a Korean company but will be marketed by Biogen in the U.S. as Byooviz.

The approval and marketing Byooviz is expected to have a make a major dent in the U.S. sales of Lucentis, which came to $363 million in the U.S. in the second quarter of 2021.

“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 issued jointly by the Korean company and Biogen

About 11 million Americans live with AMD and the prevalence of advanced AMD is increasing because of the aging U.S. population, noted the Samsung Bioepis and Biogen.

“Biosimilars could help broaden patient access to more affordable treatments and generate health care savings to offset rising costs of these complex diseases while ensuring sustainability of healthcare systems,” said Ian Henshaw, senior vice president and global head of Biosimilars at Biogen.

European and British drug regulators approved Byooviz in August.

The FDA has approved four other biosimilars developed by Samsung Bioepis: Renflexis (infliximab-abda), Ontruzant (trastuzumab-dttb), Eticovo (etanercept-ykro) and Hadlima (adalimumab-bwwd).