First FDA Approved Ophthtalmology Biosimilar Launches in the US
The biosimilar has a list price 40% less than its reference product.
Ranibizumab-nuna (Byooviz), a vascular endothelial growth factor (VEGF) inhibitor biosimilar referencing ranibizumab (Lucentis), will be available via major distributors starting July 1, 2022.1 Ranibizumab-nuna, produced by a partnership between Biogen Inc. and Samsung Bioepis Co., Ltd, was approved by the FDA in September 2021 for treating neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization. A single use vial for intravitreal has a list price of $1130, which is 40% less than the list price for ranibizumab.
Ranibizumab-nuna carries a risk for certain adverse events. Intraocular pressure increases have been noted pre- and post-intravitreal injection. Both retinal detachment and endophthalmitis may happen after injection, which means that patients should be watched following treatment. Additionally, there is a potential risk of arterial thromboembolic events with intravitreal use of VGEF inhibitors.
In the press release announcing the launch, Senior Vice President and Global Head of Biosimilars at Bioge, Ian Henshaw said, “The launch of Byooviz in the US marks an important moment for patients, health care providers, payers, and the entire health care system. Patients suffering from retinal vascular disorders now have a more affordable treatment option. 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 health care system billions of dollars.”
Reference
1. Biogen and Samsung Bioepis’ BYOOVIZ (ranibizumab-nuna) launches in the United States. News Release. Biogen Inc. June 2, 2022. Accessed June 10, 2022. https://investors.biogen.com/news-releases/news-release-details/biogen-and-samsung-bioepis-byooviztm-ranibizumab-nuna-launches
