Chinese biosimilar developer Bio-Thera Solutions Ltd. has received approval from the US Food and Drug Administration for its Avastin (bevacizumab) biosimilar Avzivi (bevacizumab-tnjn). The drug has already been approved in China since November 2021, as well as in other Asian countries.
Key takeaways:
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The FDA has approved Bio-Thera’s bevacizumab biosimilar, which will be marketed in the US as Avzivi
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The drug is both Bio-Thera’s second FDA-approved product and the second biosimilar researched, developed and manufactured by a Chinese company to be made available in the US
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The product will be
Avzivi is both Bio-Thera’s second FDA-approved product and the second biosimilar drug researched, developed and manufactured by a Chinese pharmaceutical company to receive US approval. The first was Bio-Thera’s Actemra (tocilizumab) biosimilar Tofidence (tocilizumab-bavi), which was approved in September in partnership with Biogen, Inc.