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Bio-Thera submitted a marketing authorization application (MAA) for the Avastin biosimilar BAT1706 to the European Medicines Agency.

 Last Update: 2020-12-15
 Source: Internet
 Author: User

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Bio-Thera Solutions, a Chinese biopharmaceutical company, recently announced that it has submitted TOMA1706, a biosimilar of Avastin® (Beva monoantin), to the EMA.
Bio-Thera has asked for approval of the BAT1706 listing in EU member states, including Iceland, Norway and Liechtenstein.
Shengfeng Li, founder and CEO of Bio-Thera, said, "Bio-Thera intends to bring our biosimilars and innovative therapies to patients around the world, and this submission is an important step in expanding BAT1706's global market."
beva monoantigen is a humanized monoclonal antibody that targets endothormic growth factors (VEGFs).
it can specifically bind VEGF and block VEGF's binding to its receptors, thereby reducing new blood vessel formation and inducing the degradation of existing blood vessels, thereby inhibiting tumor growth.
Beval monoantigen has been approved in Europe for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, epithelial ovarian cancer, fallopian tube and primary peritina cancer, and cervical cancer.
China's National Drug Administration (NMPA) is reviewing BAT1706's application for a biologics license to treat metastatic colorectal and non-small cell lung cancer.
Bio-Thera plans to submit THE BAT1706 BLA to the U.S. Food and Drug Administration (FDA) by the end of 2020.
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