The US Food and Drug Administration has set a goal date under the Biosimilar User Fee Act of 27 November 2021 for Bio-Thera Solutions’ BAT1706 biosimilar bevacizumab candidate, having accepted for filing the Chinese firm’s biologics license application referencing Roche’s Avastin oncology blockbuster.
Bio-Thera Follows EU Bevacizumab Biosimilar Filing With FDA Goal Date
Biosimilar Now Accepted For Filing With Three Major Regulators
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.
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