Harrow Re-Launches BYOOVIZ (ranibizumab-nuna) in the United States
On July 1, 2026, Harrow announced the commercial launch of BYOOVIZ (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTIS (ranibizumab). BYOOVIZ was developed by Samsung Bioepis Co., Ltd. (“Samsung Bioepis”).
BYOOVIZ was originally launched in the United States by Biogen in 2022. In October 2024, Biogen notified Samsung Bioepis of their decision to terminate their commercialization agreement within the United States and Canada. In July 2025, Harrow announced that it entered into an exclusive U.S. commercialization agreement with Samsung Bioepis, granting Harrow exclusive U.S. commercial rights to Samsung Bioepis’s ophthalmology biosimilar portfolio. The portfolio includes BYOOVIZ (ranibizumab-nuna), referencing LUCENTIS (ranibizumab), and OPUVIZ (aflibercept-yszy), an FDA-approved biosimilar referencing EYLEA (aflibercept). Harrow’s launch of BYOOVIZ marks the first commercial product under this partnership.
BYOOVIZ, the first ophthalmic biosimilar approved by the FDA, is indicated for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. The product received interchangeability status by FDA in October 2023.
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