On 17 July 2025, Samsung Bioepis announced that it has entered into a licence, development and commercialisation agreement with eyecare pharmaceutical company, Harrow, in relation to Samsung Bioepis’ US ophthalmology portfolio. The agreement follows Biogen’s October 2024 decision to terminate its November 2019 agreement with Samsung Bioepis, within the US and Canada, for commercialisation of Samsung Bioepis’ ophthalmology biosimilars.
Under the new agreement, Harrow will assume full commercial responsibility in the US for Samsung Bioepis’ Byooviz® (ranibizumab-nuna), biosimilar to Genentech’s Lucentis®, and Opuviz® (aflibercept-yszy), biosimilar to Regeneron’s Eylea®, upon full transition of Biogen’s commercialisation rights back to Samsung Bioepis by the end of 2025.
Opuviz® was the first FDA approved interchangeable aflibercept biosimilar (with Biocon’s Yesafili™) in May 2024. The US launch date for the product remains uncertain due to ongoing patent litigation brought by Regeneron against Samsung Bioepis (amongst others) regarding aflibercept. A preliminary injunction was granted, and remains in place, preventing Opuviz®’s US launch (14 June 2024, upheld on appeal on 29 January 2025).
Byooviz® was FDA approved in September 2021, launched in the US on 2 June 2022 and approved as interchangeable to Lucentis® across all approved indications in October 2023.