Biogen, Samsung Bioepis launch Byooviz as a biosimilar to Lucentis

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The treatment offers patients with neovascular age-related macular degeneration a cheaper option, the companies say.

Biogen and Samsung Bioepis have commercialized ranibizumab-nuna (Byooviz), a biosimilar referencing ranibizumab (Lucentis; Genentech), in the United States and have shared collaborations with patient advocacy and professional organizations, healthcare provider engagement and promotional activities the company with a statement.

“The start of [ranibizumab-nuna] in the US marks an important moment for patients, healthcare providers, payers and the entire healthcare system. Patients suffering from retinal vascular disease now have a more affordable treatment option,” said Ian Henshaw, Biogen’s senior vice president and global head of biosimilars, in a statement.

“Our research with physicians shows that cost is cited as the main barrier for patients to initiate treatment, with a third of patients unable to afford medication. [Ranibizumab-nuna] has the potential to expand access for patients suffering from retinal diseases that can lead to permanent vision loss, while also providing the [US] healthcare system billions of dollars,” Henshaw said.

Ranibizumab-nuna will be commercially available on July 1, 2022 through major distributors in the United States at a list price of $1,130 per single-use vial for administration of 0.5 mg via 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 said to be responsible for the majority of blindness or severe vision loss associated with AMD.

Anti-vascular endothelial growth factor (VEGF) therapies have become the standard of care for neovascular AMD. In practice, however, 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 to the [United States] is an important step in expanding 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 patient access to the medicines they need, and we will continue to advance our pipeline to improve access to biologic treatments by leveraging our decades of development, manufacturing and commercialization experience of these important biological preparations. ”

Ranibizumab-nuna is the first biosimilar to be launched in the United States through the Biogen-Samsung Bioepis partnership. In addition to the US, ranibizumab-nuna has also been approved as the first biosimilar for ophthalmology in Canada, Europe and the UK.

The companies’ commercialization agreement includes two ophthalmic candidates, ranibizumab-nuna and SB15, a biosimilar candidate that references aflibercept (Eylea; Regeneron).

Ranibizumab-nuna, a VEGF inhibitor, is indicated for intravitreal use and as a biosimilar to ranibizumab injection in subjects with neovascular AMD, macular edema secondary to myopic choroidal neovascularization, and retinal vein occlusion.

Patients should be monitored after the injection, the statement said.

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

Relation

Biogen and Samsung Bioepis’ Byooviz (ranibizumab-nuna) launches 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

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