FDA approves bevacizumab biosimilar ‘bevacizumab-tnjn’ for lung and colorectal cancer

Credit: U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) has approved Bio-Thera Solutions’ bevacizumab (Avastin) biosimilar, bevacizumab-tnjn (Avzivi), for the treatment of lung and colorectal cancer.¹ The decision marks Bio-Thera Solutions’ second FDA-approved product in the United States.

The decision, announced on December 7, 2023, 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), reducing angiogenesis and inhibiting tumor growth.

Some of the clinical data includes a randomized, double-blind, single-dose study comparing the safety, immunogenicity, and pharmacokinetics of the biosimilar to the U.S. and European reference bevacizumab in healthy volunteers. Results from a three-dose parallel phase 1 study were included. . Given these results, researchers are conducting a randomized, double-blind, three-arm parallel Phase 3 study focused on the efficacy, safety, and immunogenicity of BAT1706 in patients with advanced non-squamous lung cancer. A test was conducted. Both studies demonstrated biological similarity between BAT1706 and the reference product.

“Bevacizumab is widely used around the world to treat lung cancer, colorectal cancer, and many other cancers,” said Professor Li Zhang, principal investigator of Avzivi’s global Phase III trial. mentioned in.¹ “International Phase 3 clinical trials confirmed that Avzivi is highly similar to Avastin® in terms of efficacy, safety, and immunogenicity. We look forward to providing new, cost-effective treatment options for patients with colorectal cancer. Bio-Thera continues to manufacture high-quality biosimilars that are available to patients around the world. Masu.”

References

1. ^{Bio-Thera Solutions, L. (December 7, 2023). FDA approves Bio-Thera Solutions’ Avzivi® (bevacizumab-tnjn), a biosimilar that references Avastin®. PR Newswire: Press release distribution, targeting, monitoring, and marketing. https://www.prnewswire.com/news-releases/fda-approves-bio-thera-solutions-avzivi-bevacizumab-tnjn-a-biosimilar-referencing-avastin-302009433.html}