On 1 July 2026, Samsung Bioepis and Harrow announced the relaunch of Byooviz® (ranibizumab), biosimilar to Genentech’s Lucentis®, in the US.
The relaunch follows the transition of Biogen’s commercialisation rights for biosimilar ranibizumab (and biosimilar aflibercept) back to Samsung Bioepis after Biogen terminated a November 2019 agreement with Samsung Bioepis for the US and Canada. Samsung Bioepis entered into a partnership with Harrow in July 2025 for the US commercialisation of Byooviz® (and Opuviz® (aflibercept)) on full return of the commercial rights.
Byooviz® was approved in the US in September 2021 for the treatment of patients with neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, and myopic choroidal neovascularisation. It was originally launched in the US in June 2022 and was granted interchangeability designation by the FDA in October 2023.
The following ranibizumab biosimilars are also approved in the US: Sandoz’s Cimerli® (August 2022, rights acquired by Sandoz from Coherus in March 2024), Formycon’s Nufymco® (December 2025) and Lupin’s Ranluspec® (June 2026).