On July 17, 2025, Harrow, Inc. (“Harrow”), announced an agreement with Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) to acquire the U.S. commercial rights to two of Samsung Bioepis’s biosimilars, BYOOVIZ® (ranibizumab-nuna) and OPUVIZ™ (aflibercept-yszy). Harrow is a North American pharmaceutical company that specializes in ophthalmologic products including topical antibiotic/corticosteroid combinations, anesthetics, and dry eye disease treatments.
BYOOVIZ®, a biosimilar referencing Genetech’s LUCENTIS®, was the first ophthalmology biosimilar approved in the United States. It is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. OPUVIZ™, also a VEGF inhibitor, is a biosimilar referencing Regeneron’s EYLEA® and is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy. Both BYOOVIZ® and OPUVIZ™ were granted interchangeable biosimilar status by the FDA.
BYOOVIZ® and OPUVIZ™ were launched in the United States through a Samsung Bioepis-Biogen partnership formed in November 2019 that granted Biogen exclusive commercialization rights for both drugs in the United States, Canada, Europe, Japan and Australia. Biogen notified Samsung Bioepis of its decision to terminate the agreement within the United States and Canada in October 2024.