Posted by Michael Wonder on 18 Nov 2020
Samsung Bioepis and Biogen announce FDA filing acceptance of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
18 November 2020 - Samsung Bioepis and Biogen today announced that the U.S. FDA has accepted for review the biologics license application for SB11, a proposed biosimilar referencing Lucentis (ranibizumab).
Samsung Bioepis announced in November 2019 that it entered into a new commercialisation agreement with Biogen for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the U.S., Canada, Europe, Japan and Australia.
