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New Approval Alert: Bio-Thera/Sandoz’s Biosimilar Bevacizumab Approved in Europe

Jul 30, 2024

On 30 July 2024, Bio-Thera Solutions announced that the European Medicines Agency (EMA) has approved Avzivi® (BAT1706), biosimilar to Genentech’s Avastin® (bevacizumab), for treating various cancers.

In September 2021, Bio-Thera and Sandoz entered an agreement under which Sandoz has the commercialisation rights to Avzivi® in Europe, the US, Canada and other international markets.  Avzivi® was FDA approved in December 2023 and is approved in China as Pobevcy®.

The first bevacizumab biosimilar was approved in the US in September 2017 and in Europe in January 2018.  More recently, in March 2024, Dr Reddy’s launched its Versavo® (bevacizumab) in the UK, five years after its Indian launch.