The treatment offers patients with neovascular age-related macular degeneration a more affordable option, the companies say.
Biogen and Samsung Bioepis launched ranibizumab-nuna (Byoviz), a biosimilar referencing ranibizumab (Lucentis; Genentech) in the US and began collaborations with patient advocacy groups and professional societies, provider engagement healthcare and promotional activity, the companies said in a statement.
“The launch of [ranibizumab-nuna] in the United States marks an important moment for patients, health care providers, payers and the entire health care system. Patients with retinal vascular disorders now have a more affordable treatment option,” said Ian Henshaw, senior vice president and global head of biosimilars at Biogen, in a statement.
“Our research with physicians shows that cost is cited as one of the main barriers preventing patients from starting treatment, with a third of patients unable to afford medication. [Ranibizumab-nuna] has the potential to expand access for patients with retinal disorders that can lead to permanent vision loss, while saving [US] billion-dollar health care system,” Henshaw said.
Ranibizumab-nuna will be commercially available on July 1, 2022, through major distributors across the United States, with a list price of $1,130 per single-use vial to deliver 0.5 mg by intravitreal injection.
This list price is approximately 40% lower than the Lucentris list price.
The FDA approved ranibizumab-nuna 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 AMD, although less common than dry AMD, is responsible for the majority of blindness or severe vision loss associated with AMD, according to the statement.
Anti-vascular endothelial growth factor (VEGF) therapies have become the reference treatment for neovascular AMD. However, in the real world, the costs associated with the treatment of neovascular AMD make it difficult to achieve optimal clinical conditions.
“The launch of BYOOVIZ, the first ophthalmic 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, in the statement. “Samsung Bioepis’ priority is to ensure patients have access to the medicines they need, and we will continue to advance our pipeline to provide greater access to biological treatments, leveraging our decade of experience in the development , manufacturing and marketing of these important biologics. ”
Ranibizumab-nuna is the first biosimilar launched in the United States under the partnership between Biogen and Samsung Bioepis. In addition to the United States, ranibizumab-nuna has also been approved as the first ophthalmic biosimilar in Canada, Europe and the United Kingdom.
The marketing agreement between the two companies relates to 2 candidates in ophthalmology, ranibizumab-nuna and SB15, a biosimilar candidate referencing aflibercept (Eylea; Regeneron).
Ranibizumab-nuna, a VEGF inhibitor, is indicated for intravitreal use and as a biosimilar to ranibizumab injection for people with neovascular AMD, macular edema following myopic choroidal neovascularization and retinal vein occlusion.
Patients should be monitored after the injection, according to the statement.
Additionally, there is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
Launch of Byooviz (ranibizumab-nuna) from Biogen and Samsung Bioepis in the United States. Biogenic. Press release. June 2, 2022. Accessed June 3, 2022. http://media.biogen.com/news-releases/news-release-details/biogen-and-samsung-bioepis-byooviztm-ranibizumab-nuna-launches