Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that its biosimilar version of Roche’s Avastin, Avzivi (bevacizumab), has received market approval from the European Commission (EC). The approval encompasses all existing indications for Avastin, which include the treatment of a range of cancers such as metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, metastatic renal cell cancer, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, and metastatic cervical cancer.
Bevacizumab, a human anti-VEGF monoclonal antibody (mAb), was initially approved in China in February 2010 and has been included in the National Reimbursement Drug List (NRDL) since 2017. Bio-Thera has strategically licensed its biosimilar to various partners for different regions. In August 2021, it licensed Greater China rights to BeiGene in a deal valued up to USD 165 million. Other license agreements include a December 2020 deal with Brazil’s Biomm SA, a January 2019 deal with India’s Cipla Ltd (NSE.CIPLA) for certain emerging markets, and a significant September 2021 deal with Switzerland-based Novartis’ generics unit Sandoz AG for the US, Europe, Canada, and other regions, worth USD 155 million. Avzivi gained approval in the US in December 2023.- Fineline.com
