Bio-Thera Solutions , a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars,  announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Avzivi^® (bevacizumab), a biosimilar monoclonal antibody referencing AVASTIN^®. The CHMP's positive opinion will now be referred to the European Commission, which will decide whether to grant marketing authorization for Avzivi^®.

"Bio-Thera is committed to developing high-quality biosimilars to expand patient access to important therapeutics like bevacizumab," said Shengfeng Li, CEO of Bio-Thera Solutions. "The positive CHMP recommendation for Avzivi^®demonstrates that commitment to patients, healthcare providers, and healthcare systems in Europe."

This positive CHMP opinion on Avzivi^® was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of Avzivi^® was conducted and supports biosimilarity with the reference biologic product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of Avzivi^® with both the EU and US reference product in healthy volunteers. In addition, a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared Avzivi^® with the reference product to confirm equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with Advanced Non-Squamous Non-Small Cell Lung Cancer. The totality of evidence demonstrated Avzivi^® is a biosimilar of the reference biologic.

Bio-Thera and Sandoz entered into a license and commercialization agreement for Avzivi^® (BAT1706) in September 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Sandoz will have the right to commercialize the medicine upon approval and successful Marketing Authorization Holder Transfer in the US, Europe*, Canada and selected other countries.

*Includes the European Economic Area (EEA), United Kingdom, Switzerland, the Balkan States and selected countries in Eastern Europe.