- Samsung Bioepis and Biogen (NASDAQ:BIIB) has announced that the FDA has accepted for review the marketing application for SB11, a proposed biosimilar referencing Genentech's Lucentis (ranibizumab), an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders.
- In October, SB11 was accepted by the European Medicines Agency. If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three anti-TNF biosimilars in Europe; BENEPALI, IMRALDI and FLIXABI.
- In November last year, Samsung Bioepis collaborated with Biogen for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (Regeneron/Bayer' Eylea aflibercept).
- https://seekingalpha.com/news/3637415-fda-accepts-biogens-u-s-application-for-lucentis-biosimilar
Wednesday, November 18, 2020
FDA accepts Biogen's U.S. application for Lucentis biosimilar
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