1. FDA Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (ranibizumab-nuna). 2022. https://investors.biogen.com/news-releases/news-release-details/fda-approves-samsung-bioepis-and-biogens-byooviztm-sb11.
2. Ranibizumab Biosimilar (Byooviz) Gains EU Marketing Authorization. 2022. https://www.centerforbiosimilars.com/view/samsung-bioepis-byooviz-gains-ema-marketing-authorization.
3. Woo SJ, Veith M, Hamouz J, Ernest J, Zalewski D, Studnicka J, et al. Efficacy and safety of a proposed ranibizumab biosimilar product vs a reference ranibizumab product for patients with neovascular age-related macular degeneration: a randomized clinical trial. JAMA Ophthalmol. 2021;139:68–76.
4. Bressler NM, Veith M, Hamouz J, Ernest J, Zalewski D, Studnicka J, et al. Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes. Br J Ophthalmol. 2021:bjophthalmol-2021-319637.
5. European Commission approves FYB201/Ranivisio®1 (Ranivisio—Ranibizumab), a biosimilar to Lucentis. 2022. https://www.formycon.com/en/press-release/european-commission-approves-fyb201-ranivisio1-ranivisio-ranibizumab-a-biosimilar-to-lucentis2/.