Bio-Thera Ventures Outside China With European Bevacizumab Filing
Files BAT1706 Biosimilar Of Avastin With EMA; FDA Filing Coming Soon
China’s Bio-Thera Solutions has ventured outside of its domestic market for the first time by filing an application for a biosimilar version of Avastin with the European Medicines Agency. The company has also revealed its timeline for a submission to the FDA.
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Bio-Thera Solutions had been hoping to become the first Chinese biosimilars developer to win an FDA approval, for its BAT1706 bevacizumab candidate. However, the announced FDA action date for the application has come and gone with no word from the company or regulator.
Sandoz has plugged another gap in its off-patent oncology pipeline, from which the company has rolled-out four marketed oncology biosimilars, by bringing in Bio-Thera Solutions’ BAT1706 proposed biosimilar to Avastin, including in the US and Europe.
China’s Bio-Thera is continuing its journey to bring biosimilars to patients across the globe, with its BAT1706 biosimilar bevacizumab candidate accepted for filing by the US Food and Drug Administration.