Samsung Bioepis and Harrow presented interim post-marketing surveillance data for their biosimilar SB11, showing it has a comparable safety profile to Lucentis and maintains efficacy in switched patients. This positive data supports the clinical confidence in SB11, potentially increasing its market adoption and competitive position against the reference drug.
Samsung Bioepis and Harrow presented interim post-marketing surveillance (PMS) data for SB11 (BYOOVIZ® / AMELIVU®), a biosimilar referencing Lucentis, at a major ophthalmology conference. The key finding is that SB11 demonstrates a comparable safety profile to Lucentis in a real-world setting and shows functional and anatomical improvements in treatment-naïve patients, while maintaining efficacy in switched patients. This is significant because it provides strong clinical validation for SB11, which is crucial for increasing physician confidence and market adoption. For Harrow, as a co-presenter and distributor, this positive data could lead to increased sales and market share for BYOOVIZ. For Roche (developer of Lucentis), this reinforces the competitive pressure from biosimilars. In the short term, this news could boost investor confidence in HROW. Long-term, it strengthens SB11's position in the ophthalmic market, posing a continued threat to Lucentis's sales.