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Samsung Bioepis And Biogen Announce FDA Filing Acceptance Of SB11, A Proposed Biosimilar Referencing Lucentis

INCHEON, South Korea and CAMBRIDGE, Mass., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Biogen Inc. (NASDAQ:BIIB) today announced that the U.S. Food and Drug Administration (FDA) has accepted

· 11/18/2020 07:01

INCHEON, South Korea and CAMBRIDGE, Mass., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Biogen Inc. (NASDAQ:BIIB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application for SB11, a proposed biosimilar referencing Lucentis®1 (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.