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Samsung Bioepis, Biogen Announce FDA Filing Acceptance of Lucentis Biosimilar
December 04, 2020Samsung 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
November 20, 2020The 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
October 10, 2020The European Medicines Agency (EMA) has accepted for review the marketing authorisation for Biogen and Samsung Bioepis’ biosimilar referencing Genentech's Lucentis (ranibizumab).
Pharma Sources Insight January 2025
