Source / Disclosures
Disclosures: Singh reports consulting for Alcon, Bausch + Lomb, Biogen, Genentech, Gyroscope, Novartis and Regeneron.
Byooviz, a biosimilar referencing Lucentis, has been launched in the United States and will be commercially available on July 1, according to a press release.
“Byooviz ushers in a new era of biosimilars into ophthalmology and an alternative for patients and providers. This will be the test balloon for other future biosimilars as providers will evaluate the efficacy and safety of these drugs. Byooviz provides a gold standard drug in a cheaper format, which will be welcomed by patients and providers, ”OSN Associate Medical Editor Rishi P. Singh, MD, told Healio / OSN.
Byooviz (ranibizumab-Nuna, Biogen / Samsung Bioepis) was approved by the FDA in September 2021 for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. It is the first FDA-approved biosimilar for an ophthalmic indication and has received a marketing authorization also in Europe, the United Kingdom and Canada.
Biosimilars are Biologics in which the active substance has been demonstrated via pharmaceutical data and comparability studies to be highly similar to the reference brand-name drug. By demonstrating biosimilarity, the biologic can rely on safety and efficacy evidence gained by the reference medicine.
At a list price of $ 1,130 per single vial, 40% lower than the current list price of Lucentis (ranibizumab, Genentech), “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 health care system billions of dollars, ” Ian Henshaw, senior vice president and global head of biosimilars at biogen, said in the release.
The Biogen and Samsung Bioepis commercialization agreement also includes SB15, a biosimilar candidate referencing Eylea (aflibercept, Regeneron).
Singh told Healio / OSN he believes that the impact of biosimilars on clinical practice will largely depend upon the competition in the Marketplace.
“Most providers are focused on durability. Studies of Byooviz in the future will hopefully be able to show comparable durability to other anti-VEGF agents, ”they said.