Bio-Thera Solutions has submitted a MAA for BAT 1706, a proposed biosimilar to Avastin to EMA.

Bio-Thera Solutions has submitted the MAA for BAT 1706, a proposed biosimilar to Avastin (bevacizumab), to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the European Union (EU) Member States, Iceland, Norway and Liechtenstein. A Biologics License Application seeking approval for BAT 1706 for the treatment of metastatic carcinoma of the colon or rectum and non–small cell lung cancer is under review by the China National Medicinal Product Administration (NMPA). Bio-Thera intends to submit a BLA for BAT 1706 to the FDA before the end of 2020.