Bio-Thera’s Bevacizumab US Action Date Passes Without Approval

Chinese Developer And Partner Sandoz Remain Quiet On Fate Of Avastin Biosimilar

 
• By Dave Wallace

Bio-Thera Solutions had been hoping to become the first Chinese biosimilars developer to win an FDA approval, for its BAT1706 bevacizumab candidate. However, the announced FDA action date for the application has come and gone with no word from the company or regulator.

27 November 2021 calendar date marked
The 27 November action date has come and gone • Source: Alamy

A key date has passed for Bio-Thera Solutions’ proposed US biosimilar to Avastin (bevacizumab), with the previously-announced US Food and Drug Administration action date of 27 November 2021 not producing any announcement of approval from the applicant or the agency.

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