Samsung Bioepis Reports Results of SB11 (proposed biosimilar ranibizumab) in P-III Study for Neovascular Age-Related Macular Degeneration

Samsung Bioepis Reports FDA’s Acceptance of BLA for SB8 (biosimilar, bevacizumab)

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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