Biogen/Samsung Bioepis Launch the Biosimilar Byooviz

Byooviz, the first FDA approved ophthalmology biosimilar for macular degeneration, will be priced 40% lower than the reference product. It will be commercially available on July 1, 2022.

Biogen and Samsung Bioepis have launched Byooviz (ranibizumab-nuna) as the first biosimilar to Genentech’s Lucentis (ranibizumab) for the treatment of several eye diseases and conditions. This includes neovascular (wet) age-related macular degeneration, a leading cause of vision loss and blindness for Americans over the age of 65.

Byooviz will be commercially available on July 1, 2022, through major distributors across the United States. The list price will be $1,130 per single use vial to administered by injection to the back of the eye, which is 40% lower than the current list price of Lucentis.

“Our research with physicians shows cost is cited as a leading barrier to patients initiating treatment, with one third of patients unable to afford medication,” Ian Henshaw, senior vice president and global head of biosimilars at Biogen, said in a press release. “Byooviz has the potential to expand access to patients suffering from retinal disorders that can result in permanent vision loss, while also saving the U.S. healthcare system billions of dollars.”

The FDA approved Byooviz in September 2021 for the treatment of wet macular degeneration (AMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Related: FDA Approves First Biosimilar to Treat Macular Degeneration

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 another ophthalmology biosimilar candidate, SB15, which references Regeneron’s Eylea (aflibercept). Samsung Bioepis is responsible for development, regulatory registration, and manufacture of the products, while Biogen is responsible for commercialization.