Samsung Bioepis and Biogen Announce EMA Filing Acceptance of SB11 (biosimilar, ranibizumab)

 Samsung Bioepis and Biogen Announce EMA Filing Acceptance of SB11 (biosimilar, ranibizumab)

Shots:

  • EMA has accepted to review the MAA for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). If approved, SB11 will join a growing number of biosimilars developed by Samsung Bioepis and commercialized by Biogen
  • In Nov 2019, Samsung Bioepis announced that it entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates: SB11 (ranibizumab) and SB15 (aflibercept) in the US, Canada, Europe, Japan, and Australia
  • Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness

Click here ­to­ read full press release/ article | Ref: BIOGEN | Image: The Investor