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FDA Approves Bio-Thera’s Biosimilar Referencing Roche’s Avastin

Avzivi is the second biosimilar researched and manufactured by a Chinese pharmaceutical company to receive FDA approval.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Bio-Thera Solutions, Ltd., based in Guangzhou, China, received approval from the U.S. FDA for Avzivi (bevacizumab-tnjn), a biosimilar referencing Roche’s Avastin. Avzivi is Bio-Thera’s second product approved by the FDA and is the second biosimilar developed and manufactured by a Chinese pharma company to receive FDA approval in the U.S.   The approval is based on analytical, non-clinical and clinical data. Analytical characterization between BAT1706 and Avastin was conducted on structur...

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