Clinical TrialJul 20, 2026, 08:03 AM
Harrow & Samsung Bioepis: BYOOVIZ Biosimilar Shows Comparable Safety
AI Summary
Harrow and Samsung Bioepis presented interim data from a post-marketing surveillance (PMS) study for SB11 (BYOOVIZ® / AMELIVU®), a biosimilar referencing Lucentis, at the ASRS 44th Annual Meeting. The study demonstrated a comparable safety profile of SB11 to reference ranibizumab. It also showed clinically meaningful efficacy improvement in treatment-naïve patients and maintained efficacy in those switched from other anti-VEGF therapies, reinforcing confidence in the biosimilar.
Key Highlights
- SB11 (BYOOVIZ) showed comparable safety to reference ranibizumab in a PMS study.
- Treatment-naïve patients experienced functional and anatomical improvements with SB11.
- BCVA and CST were maintained in patients switched from other anti-VEGF treatments to SB11.
- Interim data included 298 patients (182 treatment-naïve, 116 switched).
- Mean BCVA improved by -0.10 (0.29) in treatment-naïve patients.
- Mean CST improved by -95 (125) µm in treatment-naïve patients.
- No new safety concerns were identified during the study.
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