Samsung Bioepis (CEO: Kyung-Ah Kim) announced on July 17 that it has signed a partnership agreement with U.S.-based Harrow Inc. for the commercialization of its ophthalmology biosimilars in the U.S. market.

The agreement covers Byooviz (ranibizumab, a biosimilar to Lucentis) and Opuviz (aflibercept, a biosimilar to Eylea), both developed by Samsung Bioepis. Under the new partnership, Harrow will take over exclusive sales responsibilities in the U.S. once commercialization rights—currently held by Biogen—are officially transferred at the end of 2025. Until then, Biogen will continue to manage product distribution.

Biogen initially informed Samsung Bioepis in October 2024 of its intent to terminate their 2019 agreement for North American rights to the two biosimilars. Since then, the companies have been coordinating the rights transfer process.

Byooviz received FDA approval in September 2021 for the treatment of neovascular (wet) age-related macular degeneration and macular edema following retinal vein occlusion. It has been marketed in the U.S. since June 2022. Opuviz was approved in May 2024 for indications including neovascular age-related macular degeneration and diabetic macular edema.

“Through this agreement with Harrow, a company with strong commercial capabilities in North American ophthalmology, we aim to ensure a seamless transition of U.S. rights,” said Sang-Hyun Lee, Executive Vice President and Head of Business Development at Samsung Bioepis. “We remain committed to broadening global access to high-quality biologics.”