Chinese biopharmaceutical company Bio-Thera Solutions has received the US Food and Drug Administration (FDA) approval for Avzivi (bevacizumab-tnjn), a biosimilar referencing Avastin.
Avzivi, whose original company name is BAT1706, is a humanised monoclonal antibody. It is designed to target vascular endothelial growth factor (VEGF) to inhibit tumour growth.
The biosimilar is the second US FDA-approved medication for Bio-Thera and the second biosimilar researched, developed, and produced by a Chinese pharmaceutical company to get the FDA nod in the US.
Bio-Thera CEO Shengfeng Li said: “The approval of Avzivi is another landmark accomplishment for Bio-Thera as it marks Bio-Thera’s second FDA-approved product in the US.
“As our biosimilar pipeline continues to mature, we intend to seek more approvals of biosimilars, expanding patient access to important therapies.”
The FDA approval was based on an overall analytical, non-clinical, and clinical data package that Bio-Thera provided to the agency.
To support BAT1706’s biosimilarity, a thorough analytical assessment of its structural, physicochemical, and biological properties was carried out in comparison with Avastin from the US and the European Union (EU).
The pharmacokinetics, safety, and immunogenicity of BAT1706 were compared with those of the US and EU versions of Avastin in a randomised, double-blind, single-dose, parallel Phase 1 trial in healthy volunteers.
Avzivi and Avastin were compared for effectiveness, safety, and immunogenicity in a randomised, double-blind, three-arm parallel Phase 3 study of patients with advanced non-squamous non-small cell lung cancer.
The totality of data showed that BAT1706 is comparable to the reference product bevacizumab in terms of quality, safety, immunogenicity, and efficacy.
Avzivi Phase 3 study leading investigator Li Zhang said: “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.”
Bio-Thera and Sandoz signed a licence and commercialisation agreement for Avzivi in September 2021.
Under the agreement, the Chinese firm is responsible for both product development and manufacturing. On the other hand, Sandoz will market the product in the US and other countries globally.
