Samsung Bioepis and Harrow Show Biosimilar SB11 Matches Lucentis in Real-World Study
Event summary
- Samsung Bioepis and Harrow presented interim data from a large-scale post-marketing surveillance study on SB11 at ASRS 2026.
- The study, involving 298 patients, showed comparable safety and efficacy of SB11 to reference ranibizumab (Lucentis).
- Treatment-naïve patients saw functional and anatomical improvements, while switched patients maintained efficacy.
- No new safety concerns were identified in the study.
The big picture
The study reinforces the growing trend of biosimilars gaining traction in complex therapeutic areas like ophthalmology. With SB11 demonstrating comparable efficacy and safety to Lucentis, Samsung Bioepis and Harrow are positioning themselves to capture a significant portion of the anti-VEGF market, which is critical for treating retinal diseases. The real-world evidence could accelerate adoption, particularly among cost-sensitive healthcare systems.
What we're watching
- Market Adoption
- How the real-world data will influence retina specialists' prescribing habits for SB11.
- Regulatory Confidence
- Whether the study results will bolster regulatory approvals or label expansions for SB11.
- Competitive Positioning
- The pace at which Samsung Bioepis and Harrow can leverage this data to challenge Genentech's Lucentis market share.