Samsung Bioepis has relaunched BYOOVIZ (ranibizumab-nuna) in the US through Harrow following the return of commercialization rights from Biogen. The interchangeable biosimilar to Lucentis aims to expand patient access to lower-cost anti-VEGF treatment for retinal diseases.
Written By: Amit Kumar Bharati, BPharm
Reviewed By: Pharmacally Editorial Team
Samsung Bioepis has relaunched BYOOVIZ® (ranibizumab-nuna) in the United States through its commercialization partner Harrow. The relaunch follows the transfer of US commercial rights from Biogen back to Samsung Bioepis at the end of 2025 and marks the next phase of the companies’ collaboration to expand access to ophthalmology biosimilars in the United States.
Under the agreement signed in July 2025, Samsung Bioepis remains responsible for product development, manufacturing, and regulatory activities, while Harrow oversees commercialization of both BYOOVIZ and OPUVIZ™ (aflibercept-yszy), an interchangeable biosimilar referencing EYLEA® (aflibercept).
FDA Approval and Interchangeability Status
BYOOVIZ became the first ophthalmology biosimilar approved by the US Food and Drug Administration (FDA) in September 2021. The product was initially commercialized by Biogen beginning in June 2022 before commercial rights returned to Samsung Bioepis at the end of 2025. In October 2023, BYOOVIZ received an interchangeability designation, allowing pharmacy-level substitution for the reference product were permitted under state regulations.
The biosimilar 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).
Clinical Need for Lower-Cost Anti-VEGF Therapy
Wet AMD affects approximately 1.5 million Americans living with advanced stages of the disease. Over the past two decades, anti-vascular endothelial growth factor (anti-VEGF) therapy has become the standard of care for retinal disorders, but treatment costs continue to present a significant financial burden for patients and healthcare systems.
As an interchangeable biosimilar, BYOOVIZ provides a clinically comparable alternative to the reference biologic without clinically meaningful differences in safety, purity, or potency, helping improve access to long-term anti-VEGF treatment.
Company Highlights Access Strategy
Commenting on the relaunch, Linda Choi MacDonald, Executive Vice President and Global Head of Commercial at Samsung Bioepis, said BYOOVIZ has already demonstrated its value as the first FDA-approved ophthalmology biosimilar in the United States. She added that partnering with Harrow reinforces the company’s commitment to improving access to high-quality biosimilar treatment options for retina specialists and patients nationwide.
Global Commercialization and Safety Profile
Beyond the United States, BYOOVIZ also received regulatory approvals from the European Commission and the United Kingdom in August 2021, followed by Health Canada in March 2022. Samsung Bioepis directly commercializes the product across European markets, reflecting its continued expansion in the global ophthalmology biosimilars market.
As with other intravitreal VEGF inhibitors, BYOOVIZ carries important safety warnings, including risks of endophthalmitis, retinal detachment, increased intraocular pressure, and arterial thromboembolic events. The most commonly reported adverse reactions include conjunctival hemorrhage, eye pain, vitreous floaters, and elevated intraocular pressure.
The US relaunch strengthens Samsung Bioepis’ ophthalmology biosimilar portfolio while supporting broader adoption of interchangeable anti-VEGF biosimilars and expanding patient access to more affordable treatment options for retinal diseases.
Reference
About the Writer
Amit Kumar Bharti (LinkedIn) is a pharmacy graduate from DPSRU, Delhi and healthcare writer with a strong interest in pharmaceutical research, medical writing, and evidence-based healthcare communication. He is passionate about translating complex scientific and medical information into clear, accurate, and engaging content for healthcare professionals and the pharmaceutical industry. His focus includes emerging therapies, clinical research, and recent advances in medicine.
