OR WAIT null SECS
The decision was based on both clinical and non-clinical data supporting the biosimilarity of bevacizumab-tnjn (Avzivi), previously named BAT1706.
The US Food and Drug Administration (FDA) has approved Bio-Thera Solutions’ bevacizumab (Avastin) biosimilar, bevacizumab-tnjn (Avzivi) for the treatment of lung and colorectal cancers.1 This decision marks Bio-Thera Solutions’ second FDA-approved product in the United States (US).
Announced on December 7, 2023, the decision was based on both clinical and non-clinical data supporting the biosimilarity of the drug, previously named BAT1706.
Bevacizumab-tnjn, a humanized monoclonal antibody, targets and binds to vascular endothelial growth factor (VEGF) to reduce neovascularization, thus inhibiting tumor growth.
Part of the clinical data included results from a randomized, double-blind, single-dose, 3-arm, parallel phase 1 study compared the safety, immunogenicity, and pharmacokinetics of the biosimilar with the US and European versions of reference bevacizumab in healthy volunteers. Following those results, investigators conducted a randomized, double-blind, 3-arm, parallel phase 3 study which focused on the efficacy, safety, and immunogenicity of BAT1706 in patients with advanced non-squamous non-small cell lung cancer. Both studies proved the biosimilarity of BAT1706 with the reference product.
"Bevacizumab has been widely used in the treatment for lung and colorectal cancers and many other cancers around the world," professor Li Zhang, leading investigator for global phase III study of Avzivi, said in a statement.1 "The global phase 3 clinical trial has confirmed that Avzivi is highly similar to Avastin® in terms of efficacy, safety and immunogenicity. The approval of Avzivi by the FDA will provide lung and colorectal cancer patients a new cost-effective treatment option. We hope Bio-Thera continues to make more high-quality biosimilars available to patients around the world."