Samsung Bioepis Reports P-III Study Results of SB11 (biosimilar, ranibizumab) for Neovascular Age-Related Macular Degeneration
- The long-term follow-up results from the P-III equivalence study evaluating SB11 vs Lucentis which showed the similarity in efficacy EPs reported early on was maintained through 52wks.
- The results also showed improvements in visual outcomes remained stable through 52wks. The safety profile was consistent with the known profile with no new safety concerns, 2% vs 1.1% experienced ocular TEAEs leading to the discontinuation of the study treatment
- Cumulative incidence of ADAs over the 52wk. study was 4.2% vs 5.5%, no significant differences in the incidences of ADAs or neutralizing Ab b/w groups were reported, PK analysis of 54 patients showed comparable mean serum concentrations and PK profiles
Ref: Centerforbiosimilar | Image: Samsung Bioepis
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