Biogen & Samsung Bioepis’ & Biogen's BYOOVIZ (ranibizumab-nuna) Launches in the US

Samsung Bioepis Co., Ltd. and Biogen Inc. recently announced BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS (ranibizumab), has been launched in the US. Healthcare provider engagement, promotional activity, collaborations with professional societies, and patient advocacy groups have commenced, and BYOOVIZ will be commercially available on July 1, 2022, through major distributors across the US. The list price will be $1,130 per single-use vial to administer 0.5 mg via intravitreal injection, which is 40% lower than the current list price of LUCENTIS.

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 US 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 US healthcare system billions of dollars.”

“The launch of BYOOVIZ, the first ophthalmology biosimilar in the U.S. marks a key step toward 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.

BYOOVIZ is the first biosimilar launch in the US under the Biogen and Samsung Bioepis’ partnership. In addition to the US, BYOOVIZ was also approved as the first ophthalmology biosimilar in Europe (2021), the UK (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.

As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer’s disease. Biogen is also commercializing biosimilars and focusing on advancing the industry’s most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need.

In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil fuels across the company’s operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities.