Biogen and Samsung Bioepis are launching Byooviz (ranibizumab-nuna), a biosimilar of Genentech’s Lucentis (ranibizumab).
The Food and Drug Administration approved Byooviz, a vascular endothelial growth factor inhibitor, in September 2021 for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. It is the first FDA-approved ophthalmology biosimilar, the companies said.
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 company said.
“The launch of Byooviz in the U.S. marks an important moment for patients, healthcare providers, payers and the entire healthcare system,” said Ian Henshaw, senior vice president and global head of Biosimilars at Biogen. “Patients suffering from retinal vascular disorders now have a more affordable treatment option.”
Healthcare provider engagement, promotional activity and collaborations with professional societies and patient advocacy groups have commenced.
Byooviz will be commercially available on July 1, 2022, through major distributors across the United States.
“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,” Henshaw said.“ 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.”
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. The companies said that biosimilars, which are biologics with similar efficacy and safety to reference biologics, can alleviate the financial burden associated with current anti-VEGF therapies.
“The launch of Byooviz, the first ophthalmology biosimilar in the United States, marks a key step towards increasing options and reducing the financial burden associated with current anti-VEGF treatments,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis.
Byooviz, the first biosimilar launch in the United States under the Biogen and Samsung Bioepis’ partnership, was 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).
“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,” Ko said.
Samsung Bioepis is responsible for the development, regulatory registration and manufacture of the products while Biogen is responsible for commercialization.