EMA recommends approval of biosimilar bevacizumab Avzivi

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EMA recommends approval of biosimilar bevacizumab Avzivi

Biosimilars/News | Posted 25/06/2024 0 Post your comment

On 30 May 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization for Avzivi (bevacizumab), Bio-Thera Solutions’ (Bio-Thera) biosimilar of the reference product Avastin.

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].

Avzivi is for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC), renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

If approved, Avzivi will be available as a 25 mg/mL concentrate solution for infusion.

Avzivi is developed and manufactured by Bio-Thera and will be commercialized by Sandoz according to their September 2021 licensing agreement, pending approval from the European Commission for marketing authorization.

The positive opinion was based on the totality of analytical, non-clinical, and clinical evidence showing that Avzivi is a biosimilar of the reference product. The data package included extensive analytical characterization of the structural, physicochemical, and biological properties of Avzivi; findings from a randomized, double-blind, single-dose, three-arm, parallel-group phase I trial comparing the pharmacokinetics, safety, and immunogenicity of Avzivi with both the European Union and US reference products in healthy individuals; and findings from a randomized, double-blind, multi-dose, three-arm, parallel-group phase III study comparing Avzivi with the reference product to substantiate equivalent efficacy and comparable pharmacokinetic, safety, and immunogenicity profiles in patients with advanced non-squamous NSCLC.

Avzivi was approved in the US in December 2023 [2] and is the fifth bevacizumab biosimilar to enter the US market. Avzivi is the second biosimilar of Bio-Thera to be approved by the US Food and Drug Administration, following its Actemra tocilizumab biosimilar, Tofidence [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 25]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Avzivi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 25]. Available from: www.gabionline.net/biosimilars/news/fda-approves-bevacizumab-biosimilar-avzivi
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first tocilizumab biosimilar Tofidence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 25]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-tocilizumab-biosimilar-tofidence

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