When Samsung Bioepis announced the recent US Food and Drug Administration approval of its Byooviz (ranibizumab-nuna) biosimilar, the first approved US rival to Genentech’s Lucentis, a key detail was revealed by the company that could reshape expectations about US biosimilar competition to the ophthalmic brand.
Celebrating the FDA’s first approval of a biosimilar with ophthalmic indications – with the product approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization – the Samsung Bioepis joint venture between Samsung Biologics and Biogen revealed that “pursuant to a global license agreement entered into with Genentech, Samsung Bioepis and Biogen will have freedom to market SB11 in the US as of June 2022
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