Samsung Bioepis has announced the relaunch of Byooviz (ranibizumab-nuna) in the United States in partnership with Harrow.

In July 2025, Samsung Bioepis entered into a commercialization agreement with Harrow for Byooviz, a biosimilar referencing ranibizumab (Lucentis; Genentech), and Opuviz (aflibercept-yszy), a biosimilar referencing aflibercept (Eylea; Regeneron). Following the full transition of commercialization rights from Biogen back to Samsung Bioepis at the end of 2025, Harrow assumed responsibility for commercialization of both products in the United States, while Samsung Bioepis remains responsible for their development, regulatory registration, and manufacturing, according to a company press release.

Byooviz was approved by the US Food and Drug Administration (FDA) in September 2021 as the first ophthalmic biosimilar in the United States for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. The FDA granted Byooviz an interchangeability designation in October 2023.

Outside the United States, Byooviz was approved by the European Commission and the United Kingdom in August 2021, and in Canada in March 2022. Samsung Bioepis is responsible for the product's direct commercialization in Europe. RP