INCHEON, South Korea, July 1, 2026
Samsung Bioepis has officially announced the U.S. relaunch of BYOOVIZ® (ranibizumab-nuna), the first FDA-approved ophthalmology biosimilar, through its strategic commercialization partnership with Harrow. The relaunch marks a major milestone in expanding patient access to high-quality, interchangeable biosimilar therapies for retinal diseases while strengthening competition in the ophthalmology market. Following the return of commercialization rights from Biogen at the end of 2025, Harrow has assumed responsibility for the U.S. commercialization of BYOOVIZ® and OPUVIZ™ (aflibercept-yszy), while Samsung Bioepis continues to oversee product development, manufacturing, and regulatory activities. The renewed commercialization strategy reinforces Samsung Bioepis’ long-term commitment to making vision-saving biologic therapies more affordable and accessible for patients suffering from serious retinal disorders. As healthcare systems continue to seek cost-effective alternatives to branded biologics, the relaunch of BYOOVIZ represents another significant advancement in the adoption of biosimilars across ophthalmology.
BYOOVIZ Strengthens Access to Interchangeable Ophthalmology Biosimilars
BYOOVIZ® (ranibizumab-nuna) received U.S. Food and Drug Administration (FDA) approval in September 2021, becoming the first ophthalmology biosimilar approved in the United States for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). The therapy achieved another important regulatory milestone when it received FDA interchangeability designation in October 2023, allowing pharmacists to substitute the biosimilar for its reference product, LUCENTIS® (ranibizumab), where permitted under state pharmacy laws.
Wet AMD continues to be one of the leading causes of severe vision loss among older adults, affecting approximately 1.5 million Americans living with advanced disease. By introducing a clinically equivalent and more affordable biosimilar, Samsung Bioepis aims to reduce financial barriers that often limit patient access to long-term anti-VEGF therapy, which remains the standard treatment for retinal vascular diseases.
Strategic Partnership with Harrow Expands Commercial Reach
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The relaunch follows the commercial partnership established between Samsung Bioepis and Harrow in July 2025, under which Harrow became the exclusive U.S. commercialization partner for both BYOOVIZ® and OPUVIZ™, an interchangeable biosimilar referencing EYLEA® (aflibercept). Under this agreement, Samsung Bioepis remains responsible for research, product development, manufacturing, and regulatory submissions, while Harrow oversees nationwide commercialization, physician engagement, market access, and product distribution.
Company executives emphasized that combining Samsung Bioepis’ expertise in biosimilar development with Harrow’s established ophthalmology commercial infrastructure will help accelerate physician adoption and improve patient access to proven treatment options. The collaboration is expected to strengthen competition within the rapidly growing retinal disease market while supporting healthcare providers seeking clinically validated alternatives to branded biologics.
Biosimilars Continue to Transform Ophthalmic Care
The relaunch of BYOOVIZ reflects the growing global importance of biosimilars in improving healthcare affordability without compromising quality, safety, or clinical effectiveness. Samsung Bioepis has continued expanding its ophthalmology portfolio across major global markets, with BYOOVIZ previously receiving regulatory approvals in Europe, the United Kingdom, and Canada. The company believes broader biosimilar adoption will help reduce healthcare costs while increasing treatment availability for patients living with chronic retinal diseases that require frequent intravitreal injections.
With its proven clinical performance, FDA-approved interchangeability, and renewed commercial strategy through Harrow, BYOOVIZ is well positioned to support retina specialists and ophthalmologists in delivering effective, evidence-based care for patients affected by vision-threatening diseases. The relaunch further strengthens Samsung Bioepis’ position as a global leader in biosimilar innovation, supporting wider access to advanced biologic therapies across multiple therapeutic areas.
Source: Samsung Bioepis,Harrow press release
