07.01.2026

Samsung Bioepis, Harrow Relaunch Byooviz in US Under New Commercialization Partnership

Key Takeaways Byooviz, the first FDA-approved ophthalmic biosimilar in the United States, has been relaunched through a new commercialization partnership between Samsung Bioepis and Harrow Harrow is responsible for US commercialization of Byooviz and Opuviz, while Samsung Bioepis continues to oversee development, manufacturing, and regulatory activities The relaunch is intended to expand access to lower-cost anti-VEGF treatment options for retinal diseases Samsung Bioepis has announced the relaunch of Byooviz (ranibizumab-nuna) in the United States through its new commercialization partnership with Harrow, marking the return of the ophthalmic biosimilar to the US market following the transition of commercialization rights from Biogen. Under an agreement announced in July 2025, Harrow assumed responsibility for commercialization of Byooviz, a biosimilar referencing Lucentis (ranibizumab), and Opuviz (aflibercept-yszy), a biosimilar referencing Eylea (aflibercept), after commercialization rights fully transitioned back to Samsung Bioepis by the end of 2025.