Samsung Bioepis Relaunches BYOOVIZ in U.S. via Harrow Partnership
Event summary
- Samsung Bioepis relaunched BYOOVIZ (ranibizumab-nuna) in the U.S. on July 1, 2026, partnering with Harrow for commercialization.
- Harrow now leads sales efforts after Samsung Bioepis regained full commercialization rights from Biogen by year-end 2025.
- BYOOVIZ is the first FDA-approved ophthalmology biosimilar to Lucentis, gaining interchangeability designation in October 2023.
The big picture
This relaunch underscores the growing importance of biosimilars in reducing treatment costs for retinal diseases, where anti-VEGF therapies dominate. The shift from Biogen to Harrow suggests a strategic pivot toward specialized commercialization partners in niche therapeutic areas. With wet AMD affecting millions of Americans, BYOOVIZ's success could set a precedent for other ophthalmology biosimilars.
What we're watching
- Market Penetration
- How Harrow's commercialization strategy will impact BYOOVIZ adoption rates against branded competitors.
- Regulatory Dynamics
- Whether the FDA's interchangeability designation will accelerate biosimilar uptake in ophthalmology.
- Pipeline Expansion
- The pace at which Samsung Bioepis advances other biosimilars through its partnership with Harrow.
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