Biogen, Samsung Bioepis launch USFDA approved BYOOVIZ in US

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

Neovascular (wet) AMD, although less common than dry AMD, is responsible for the majority of the severe vision loss or blindness associated with AMD. Anti-VEGF therapies have become a standard of care treatment for wet AMD, but in real-world settings, costs related with wet AMD treatment often raise challenges in achieving optimal clinical outcomes. Biosimilars, which are biologics with similar efficacy and comparable safety to reference biologics, have the potential to alleviate the financial burden associated with current anti-VEGF therapies.

"The launch of BYOOVIZ in the U.S. marks an important moment for patients, healthcare providers, payers, and the entire healthcare system. Patients suffering from retinal vascular disorders now have a more affordable treatment option," said Ian Henshaw, Senior Vice President and Global Head of Biosimilars at Biogen. "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. 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 launch of BYOOVIZ, the first ophthalmology biosimilar in the U.S. marks a key step towards increasing options and reducing the financial burden associated with current anti-VEGF treatments," said Christopher Hansung Ko, President and Chief Executive Officer, at Samsung Bioepis. "The priority of Samsung Bioepis is ensuring patients' access to the medicines they need, and we will continue to advance our pipeline to bring better access to biologic treatments, by leveraging our decade of experience in developing, manufacturing, and commercializing these important biologics," he added.

BYOOVIZ is the first biosimilar launch in the U.S. under the Biogen and Samsung Bioepis' partnership. In addition to the U.S., 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 includes two ophthalmology biosimilar candidates, BYOOVIZ and SB15, a biosimilar candidate referencing EYLEA (aflibercept). Samsung Bioepis is responsible for development, regulatory registration, and manufacture of the products, while Biogen is responsible for commercialization.