EMA accepts MAA for review for SB 8 ,a bevacizumab biosimilar
Samsung Bioepis Co., Ltd. announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for SB 8, a biosimilar candidate referencing Avastin (bevacizumab). If approved, SB8 will be commercialized in Europe by Merck Inc.
Comment: Samsung Bioepis submitted its marketing application for SB 8 to EMA in June 2019, following the completion, in October 2018, of a phase III trial for SB8 in lung cancer patients. The company intends to present the results of this phase III trial for SB8 at the European Society for Medical Oncology in September 2019.
Comment: The patents on Avastin are set to expire in Europe in January 2022 and in the US in July 2019.
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