FDA approves bevacizumab biosimilar Avzivi

Biosimilars/News | Posted 30/01/2024 post-comment0 Post your comment

On 6 December 2023, the US Food and Drug Administration (FDA) approved China–based manufacturer Bio-Thera Solutions’  bevacizumab biosimilar (BAT1706), Avzivi (bevacizumab-tnjn). This product will be marketed globally by Sandoz.

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Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian [1]. The originator/reference biological is Avastin. 

Avzivi, is indicated for treatment of:

· metastatic colorectal cancer
· non-squamous non-small cell lung cancer
· recurrent glioblastoma
· metastatic renal cell carcinoma persistent
· recurrent, or metastatic cervical cancer
· epithelial ovarian, fallopian tube, or primary peritoneal cancer 

The FDA approval of Avzivi was based on analytical, non-clinical and clinical data that demonstrated its high similarity to Avastin, with no clinically meaningful differences between the biosimilar product and the reference product.

Avzivi is administered via intravenous infusion over 90 minutes for the first infusion, over 60 minutes for the second infusion if the first infusion is tolerated, and over 30 minutes for subsequent infusions if the second, administered over 60 minutes, is also tolerated.

This bevacizumab copy biological, marketed as Pobevcy (BAT1706), received approval in China in 2021. Three other bevacizumab copy biologicals were also approved in China in 2021, namely Betta Pharmaceutica and Beijing Mabworks Biotech’s MIL60; TOT BIOPHARM’s Pusintin (朴欣汀, TAB008), and Shanghai Henlius Biotech’s Hanbeitai (汉贝泰, HLX04) [2].

Avzivi will be the fifth bevacizumab biosimilar to enter the market. Biosimilars have approximately 85% of the US bevacizumab market share, and this is Bio-Thera’s second biosimilar approved by the FDA after its Actemra biosimilar, Tofidence [3].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 30]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab
2. GaBI Online - Generics and Biosimilars Initiative. China approves three bevacizumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 30]. Available from: www.gabionline.net/biosimilars/news/china-approves-three-bevacizumab-copy-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first tocilizumab biosimilar Tofidence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 30]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-tocilizumab-biosimilar-tofidence

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