Biogen, Samsung Bioepis Launch Byooviz as Biosimilar of Lucentis

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 referencing ranibizumab (Lucentis; Genentech) in the United States and begun collaborations with patient advocacy groups and professional societies, health care provider engagement, and promotional activity, the companies said in a statement.

“The launch of [ranibizumab-nuna] 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,” Ian Henshaw, senior vice president and global head of Biosimilars at Biogen, said in a statement.

“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. [Ranibizumab-nuna] 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,” 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 administer 0.5 mg via 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, though less common than dry AMD, is responsible for the majority of the 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 treatment for neovascular AMD. However, in real-world settings, the costs related to neovascular AMD treatment make achieving optimal clinical conditions challenging.

“The launch of BYOOVIZ, the first ophthalmology biosimilar in the [United States] marks a key step toward increasing options and reducing the financial burden associated with current anti-VEGF treatments,” Christopher Hansung Ko, president and CEO at Samsung Bioepis, said in the statement. “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.”

Ranibizumab-nuna is the first biosimilar launched in the United States under the Biogen and Samsung Bioepis’ partnership. In addition to the United States, ranibizumab-nuna was also approved as the first ophthalmology biosimilar in Canada, Europe, and the United Kingdom.

The commercialization agreement of both companies includes 2 ophthalmology candidates, 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 individuals with neovascular AMD, macular edema following myopic choroidal neovascularization and retinal vein occlusion.

Patients should be monitored following the injection, according to the statement.

Additionally, there is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.

Reference

Biogen and Samsung Bioepis’ Byooviz (ranibizumab-nuna) launches in the United States. Biogen. News 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