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News List

Samsung Bioepis, Biogen Announce FDA Filing Acceptance of Lucentis Biosimilar americanpharmaceuticalreview
December 04, 2020
Samsung Bioepis and Biogen announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for SB11, a proposed biosimilar referencing Lucentis® (ranibizumab).
FDA to review Samsung Bioepis and Biogen’s biosimilar SB11 pharmaceutical-technology
November 20, 2020
The US Food and Drug Administration (FDA) has accepted Samsung Bioepis and Biogen’s biologics licence application to review the use of SB11 as a biosimilar referencing Lucentis (ranibizumab).
EMA accepts filing for Biogen/Samsung Bioepis’ Lucentis biosimilar pharmatimes
October 10, 2020
The European Medicines Agency (EMA) has accepted for review the marketing authorisation for Biogen and Samsung Bioepis’ biosimilar referencing Genentech's Lucentis (ranibizumab).