FDA Accepts Bio-Thera’s BLA for Bevacizumab Biosimilar
By EsqSocial Corporation 08/02/21
On January 28, 2021, Bio-Thera Solutions, Ltd., a biopharmaceutical company based in China, announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for BAT1706, a proposed biosimilar to bevacizumab, referencing Genentech’s Avastin®, but excluding indications under orphan drug exclusivity protection. The FDA has set November 27, 2021, as the decision date for the application. Bevacizumab is an angiogenesis inhibitor, which suppresses new blood...
By: Rothwell, Figg, Ernst & Manbeck, P.C.