On November 18, 2020, companies Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the United States Food and Drug Administration (“FDA”) accepted for review the Biologics License Application for SB11, a proposed biosimilar referencing Genentech, Inc. product Lucentis® (ranibizumab).  Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders, which are a leading cause of blindness in the United States.  SB11 is one of two opthamology biosimilar candidates jointly developed by Samsung Bioepis and Biogen in the U.S., Canada, Europe, Japan, and Australia, the other being aflibercept (“SB15”).  SB11 was accepted for review last month by the European Medicines Agency.

“The FDA filing acceptance for SB11 brings us a step closer to our goal of being able to offer affordable treatment options for people with retinal vascular disorders,” said Hee Kyung Kim, Senior Vice President and Clinical Sciences Division and Regulatory Affairs Team Leader at Samsung Bioepis.  Ian Henshaw, the Senior Vice President and Global Head of Biosimilars at Biogen, stated that SB11 and other biosimilars, “aim[] to ensure sustainability of healthcare systems by offering broader patient access to effective and more affordable treatment options.”

If approved, SB11 will join a Samsung Bioepis and Biogen biosimilar portfolio that includes three widely prescribed anti-TNF biosimilars in Europe: Benepali® (etanercept), ImraldiTM (adalimumab), and Flixabi® (infliximab).