FDA Approves Avzivi®, a Biosimilar to Avastin®
Bio-Thera Solutions, Ltd, has announced that the U.S. Food and Drug Administration has approved Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin®. Avzivi® is Bio-Thera’s second
USFDA approved product and is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States.
The FDA approval of Avzivi was based on a comprehensive analytical, non-clinical and clinical data package submitted by Bio-Thera to the FDA. Extensive analytical characterization between BAT1706 and US and EU Avastin were conducted on structural, physicochemical, and biological properties to support biosimilarity of BAT1706.
A randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety, and immunogenicity of BAT1706 with both the US and EU Avastin in healthy volunteers. A randomized, double-blind, three-arm parallel phase III study compared BAT1706 with Avastin for efficacy, safety, and immunogenicity in subjects with advanced non-squamous non-small cell lung cancer.
The totality of the evidence demonstrated that BAT1706 has similar efficacy, safety, immunogenicity, and quality as the reference product bevacizumab.
