First Ophthalmology Biosimilar Launches in US

Biogen and Samsung Bioepis announced that Byooviz (ranibizumab-nuna) has been launched on the US market as the first ophthalmology biosimilar and the first biosimilar referencing Lucentis, according to a company statement.

Ranibizumab products are used to treat patients with neovascular age-related macular degeneration (wet AMD), diabetic macular edema, proliferative diabetic retinopathy, macular edema secondary to retinal vein occlusion, or choroidal neovascularization.

Byooviz was approved by the FDA in September 2021. Prior to the US approval, it was authorized for marketing in the European Union and the United Kingdom in August 2021. Byooviz was also approved by Health Canada in March 2022. Although Byooviz is the only ranibizumab biosimilar approved in the United States, the European Union, and Canada, the United Kingdom has also approved Ongavia, Teva Pharmaceutical’s ranibizumab biosimilar.

Major distrubtions of Byooviz will occur July 1, 2022, allowing for the product to be commercially available to all patients. Byooviz will be listed for $1130 per single use 0.5 mg vial that would be administered intravitreally, about a 40% discount compared to the list price of Lucentis.

“The launch of Byooviz in the U.S. marks an important moment for patients, healthcare providers, payers, and the entire healthcare 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 healthcare system billions of dollars,” said Ian Henshaw, senior vice president and global head of Biosimilars at Biogen.

Ranibizumab is a inhibitor of vascular endothelial growth factor (anti-VEGF), which can lead to excessive blood vessel formation in the retina. AMD is the leading cause of blindness in developed countries and is estimated to impact up to 77 million people in Europe by 2050, creating a significant global burden for health care systems and societies.

Although wet AMD is less common than other forms of AMD, it accounts for the majority of severe vision loss or blindness associated with AMD. Anti-VEGF therapies are the standard of care treatment for wet AMD and the high cost of originator products, such as Lucentis, create challenges for patients related to therapy access and achieving optimal clinical outcomes.

“The launch of Byooviz, the first ophthalmology biosimilar in the US marks a key step towards increasing options and reducing the financial burden associated with current anti-VEGF treatments…. 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,” said Christopher Hansung Ko, president and CEO, at Samsung Bioepis.