FDA Approves Bevacizumab Biosimilar Bevacizumab-tnjn for Lung, Colorectal Cancers

HCP Live December 8, 2023
Lana Pine

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...

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