Samsung Bioepis Reports Results of SB11 (proposed biosimilar ranibizumab) in P-III Study for Neovascular Age-Related Macular Degeneration
Shots:
- The P-III study involves assessing of SB11 vs reference product- LUCENTIS in monthly injections (0.5mg) in 705 patients in a ratio (1:1) with nAMD
- The P-III study results demonstrated equivalent efficacy in terms of change in BCVA @8wk. and CST @4wk.- LS change in BCVA (6.2 vs 7.0 letters)- LS change in CST ( −108.4μm vs −100.1μm)- AEs (66.0% vs 66.9%). The data was to be presented at ARVO 2020 which has been cancelled due to COVID-19
- Additionally- in Nov’2019- Samsung collaborated with Biogen for two ophthalmology biosimilar candidates- SB11 (ranibizumab) and SB15 (aflibercept)- in the US- Canada- EU- Japan- and Australia
Click here to read full press release/ article | Ref: Samsung Bioepis | Image: Samsung Bioepis
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