Samsung Bioepis has relaunched its ophthalmology biosimilar Byooviz (ranibizumab-nuna) in the United States through its commercial partnership with Harrow, marking a new phase in the product's market presence following the transition of commercialisation rights from Biogen.

Under the partnership, Harrow is responsible for the commercialisation of Byooviz, a biosimilar referencing Lucentis (ranibizumab), and Opuviz (aflibercept-yszy), a biosimilar referencing Eylea (aflibercept), after Samsung Bioepis regained commercialisation rights by the end of 2025. Samsung Bioepis will continue to oversee product development, regulatory activities and manufacturing.

Byooviz was approved by the US Food and Drug Administration (FDA) in September 2021 as the first ophthalmology biosimilar in the country. It is indicated for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD), macular edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). In October 2023, the FDA granted the product interchangeability designation, allowing pharmacists to substitute it for the reference product, subject to state pharmacy laws.

The relaunch comes as demand grows for more affordable treatment options for retinal diseases. Wet AMD affects approximately 1.2 percent to 1.3 percent of adults aged 65 years and older in the United States, with nearly 1.5 million people living with advanced stages of the disease. Although anti-Vascular Endothelial Growth Factor (anti-VEGF) therapies have become the standard of care for wet AMD over the past two decades, their high cost continues to pose a financial burden for patients and healthcare systems.

Biosimilars are designed to offer comparable safety, efficacy and quality to their reference biologic products while helping improve access by reducing treatment costs.

Commenting on the relaunch, Linda Choi MacDonald, Executive Vice President and Global Head of Commercial at Samsung Bioepis, said the company remains committed to expanding access to high-quality ophthalmic biosimilars. She noted that the partnership with Harrow is expected to strengthen the availability of Byooviz for retina specialists and patients across the United States, helping more individuals access vision-preserving therapies.

Samsung Bioepis and Harrow entered into the commercialisation partnership in July 2025. While Samsung Bioepis is responsible for product development, regulatory registration and manufacturing, Harrow manages the commercial distribution and market access strategy in the US.

Beyond the United States, Byooviz has also received regulatory approvals from the European Commission and the United Kingdom in 2021, followed by Canada in 2022. Samsung Bioepis directly commercialises the product in Europe.

The relaunch strengthens Samsung Bioepis' ophthalmology biosimilar portfolio as the company continues to expand access to biologic therapies across multiple therapeutic areas, including ophthalmology, immunology, oncology, nephrology, endocrinology and neurology. Harrow, meanwhile, continues to broaden its ophthalmic product portfolio focused on retinal diseases, glaucoma, cataracts, dry eye disease and other vision-related conditions across North America.