Pharma Focus Asia

FDA Approves Avzivi® (bevacizumab-tnjn), a Biosimilar Referencing Avastin®, Developed by Bio-Thera Solutions

Friday, December 08, 2023

Bio-Thera Solutions, Ltd (688177:SH) has announced that the United States Food and Drug Administration (FDA) has given the green light for Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin®. This marks the second FDA-approved product for Bio-Thera and is the second biosimilar developed by a Chinese pharmaceutical company to gain FDA approval in the United States.

The approval of Avzivi® was based on a comprehensive analytical, non-clinical, and clinical data package submitted by Bio-Thera. Comparative analysis between BAT1706 and US and EU Avastin® included structural, physicochemical, and biological properties to establish biosimilarity. Clinical studies, including a phase I trial in healthy volunteers and a phase III trial in subjects with advanced non-squamous non-small cell lung cancer, demonstrated that BAT1706 is similar to Avastin® in terms of efficacy, safety, and immunogenicity.

Professor Li Zhang, the leading investigator for the global phase III study of Avzivi®, stated, "The approval of Avzivi® by the FDA will provide lung and colorectal cancer patients a new cost-effective treatment option."

Bio-Thera's CEO, Shengfeng Li, highlighted the significance of this achievement and expressed the company's commitment to seeking more approvals for biosimilars, expanding patient access to essential therapies.

Avzivi® (bevacizumab-tnjn) is a humanized monoclonal antibody targeting VEGF, indicated for various cancer treatments, including metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, and others. The FDA approval follows a license and commercialization agreement between Bio-Thera and Sandoz, where Bio-Thera oversees development and manufacturing, and Sandoz manages commercialization in the United States and globally.

 

Source: prnewswire.com

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