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Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis' Biosimilar- SB11 for Retinal Vascular Disorders

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Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis' Biosimilar- SB11 for Retinal Vascular Disorders

Shots:

  • EMA accepted the review of MAA for SB11 in Oct 2020. If approved- SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen- including three widely prescribed anti-TNF biosimilars in EU: BENEPALI- IMRALDI- and FLIXABI
  • In Nov 2019- Samsung Bioepis entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates- SB11 (ranibizumab) and SB15 (aflibercept)- in the US- Canada- EU- Japan- and Australia
  • Ranibizumab is an anti-VEGF therapy for retinal vascular disorders- which is a leading cause of blindness in the US

 ­ Ref: Samsung Bioepis | Image: Biogen

Click here to­ read the full press release 

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