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Bio-Thera Secures FDA Approval For Sandoz-Partnered Bevacizumab Biosimilar

Avzivi Is The Second Bio-Thera Biosimilar – And The Second Chinese Biosimilar – To Secure FDA Approval

 
• By Chloe Kent

Bio-Thera has received US Food and Drug Administration approval for its bevacizumab biosimilar, marking the second biosimilar drug researched, developed and manufactured by a Chinese pharmaceutical company to receive US approval.

Hands emblazoned with US and China flags about to shake
Bio-Thera has developed both biosimilars researched, developed and manufactured by a Chinese company to recieve US FDA approval • Source: Shutterstock

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:

  • The FDA has approved Bio-Thera’s bevacizumab biosimilar, which will be marketed in the US as Avzivi

  • 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

  • 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.

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