The treatment gives patients with neovascular age-related macular degeneration a more affordable option, the companies say.
Biogen and Samsung Bioepis have launched ranibizumab-nuna (Byooviz), a biosimilar referring to ranibizumab (Lucentis; Genentech) in the United States and have begun collaborations with patient advocacy groups and professional associations, healthcare provider engagement and promotional activities, the company said. companies in a statement.
“The launch of [ranibizumab-nuna] in the US marks an important moment for patients, providers, payers and the entire healthcare system. Patients suffering from retinal vascular disease now have a more affordable treatment option,” Ian Henshaw, senior vice president and global head of Biosimilars at Biogen, said in a statement.
“Our research with physicians shows that cost is cited as a major barrier to patients starting treatment, with a third of patients unable to afford medication. [Ranibizumab-nuna] has the potential to expand access to patients suffering from retinal disorders that can lead to permanent vision loss, while also [US] health care billions of dollars,” Henshaw said.
Ranibizumab-nuna will be commercially available on July 1, 2022 through major distributors in the United States, with a list price of $1,130 per single-use vial to administer 0.5 mg by intravitreal injection.
This list price is approximately 40% lower than the list price of Lucentris.
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, while less common than dry AMD, accounts 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 standard of care for neovascular AMD. In practice, however, the cost of neovascular AMD treatment makes achieving optimal clinical conditions a challenge.
“The launch of BYOOVIZ, the first ophthalmic biosimilar in the [United States] marks an important step toward increasing the capabilities 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 improve our pipeline to provide better access to biological treatments, leveraging our ten years of development experience , manufacturing and commercialization of these important biologics. †
Ranibizumab-nuna is the first biosimilar launched in the United States under the partnership of Biogen and Samsung Bioepis. In addition to the United States, ranibizumab nuna was also approved as the first ophthalmic biosimilar in Canada, Europe and the United Kingdom.
Both companies’ commercialization agreement includes 2 ophthalmology candidates, ranibizumab-nuna and SB15, a biosimilar candidate referring to aflibercept (Eylea; Regeneron).
Ranibizumab nuna, a VEGF inhibitor, is indicated for intravitreal use and as a biosimilar to ranibizumab injection for subjects with neovascular AMD, macular edema following myopic choroidal neovascularization and retinal vein occlusion.
According to the statement, patients should be monitored after the injection.
In addition, there is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
Biogen and Samsung Bioepis’ Byooviz (ranibizumab-nuna) launches in the United States. Biogenic. news item. June 2, 2022. Accessed June 3, 2022. http://media.biogen.com/news-releases/news-release-details/biogen-and-samsung-bioepis-byooviztm-ranibizumab-nuna-launches