Bio-Thera Solutions, Ltd., based in Guangzhou, China, received approval from the U.S. FDA for Avzivi (bevacizumab-tnjn), a biosimilar referencing Roche’s Avastin. Avzivi is Bio-Thera’s second product approved by the FDA and is the second biosimilar developed and manufactured by a Chinese pharma company to receive FDA approval in the U.S.
 
The approval is based on analytical, non-clinical and clinical data. Analytical characterization between BAT1706 and Avastin was 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 U.S. and EU Avastin in healthy volunteers. A phase III study compared BAT1706 with Avastin for efficacy, safety, and immunogenicity in subjects with advanced non-squamous non-small cell lung cancer. The evidence demonstrated that BAT1706 has similar efficacy, safety, immunogenicity and quality as the reference product bevacizumab.
 
Bio-Thera and Sandoz entered into a license and commercialization agreement for Avzivi in September 2021. Under the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Sandoz is responsible for the commercialization of Avzivi in the U.S. and other countries around the world.