Bio-Thera Reports MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin
Shots:
- The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States- Iceland- Norway- and Liechtenstein
- The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma of the colon or rectum and NSCLC is under NMPA’s review
- The company plans to submit a BLA for BAT1706 to the US FDA by the end of 2020. Bevacizumab is a mAb that targets VEGF thus reduces neovascularization- thereby inhibiting tumor growth
Ref: Businesswire | Image: Businesswire
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