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

November 18, 2020 Auto Bot Acceptance, Biogen, Biosimilar, Lucentis, ranibizumab, regulatory, Samsung Bioepis 0

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

Click here ­to­ read full press release/ article | Ref: Samsung Bioepis | Image: Samsung Bioepis

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