If authorized, SB2 will be marketed in Europe by Biogen Idec Samsung Bioepis Co., Ltd., today announced that the Marketing Authorization Application (MAA) for SB2, its Remicade (Infliximab) biosimilar candidate, has been submitted to the European Medicines Agency (EMA). This is the second biosimilar candidate MAA that Samsung Bioepis has submitted to the EMA. The MAA is based on results from an extensive head-to-head preclinical data package comparing SB2 to the originator, a head-to-head Phase
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Siam Yamato...