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Approval Alert: Sandoz/Bio-Thera’s Avzivi® Bevacizumab Biosimilar FDA Approved

Dec 8, 2023

Bio-Thera announced that its Avzivi® (BAT1706), biosimilar to Genentech’s Avastin® (bevacizumab) is FDA approved with a full indication set (excluding hepatocellular carcinoma).  Bio-Thera is the only Chinese company to have received marketing approval for a biosimilar in the US, and this is the second Bio-Thera biosimilar to be US approved.

The Avzivi trade name is owned by Novartis, but the product will be marketed by Sandoz in the US pursuant to the license and commercialisation agreement entered into between Bio-Thera and Sandoz in September 2021.  Avzivi® is currently under regulatory review by the EMA (MA submitted on 26 November 2020).  Avzivi® has already been approved in China and is being supplied as Pobevcy®.