Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received market approval from the U.S. Food and Drug Administration (FDA) for Avzivi (bevacizumab), a biosimilar version of Roche’s (SWX: ROG) Avastin. The approved indications for Avzivi include non-small cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), glioblastoma (GBM), renal cell carcinoma, cervical cancer, and ovarian cancer.
Bevacizumab is a human anti-VEGF monoclonal antibody (mAb) that was first approved in China in February 2010 and has been included on the National Reimbursement Drug List (NRDL) since 2017.
In a significant licensing deal, Bio-Thera granted Greater China rights for Avzivi to BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) in August 2021, a transaction valued at up to USD 165 million. Additionally, Bio-Thera has licensed its biosimilar to several companies globally: Biomm SA in Brazil in December 2020, Cipla Ltd. (NSE: CIPLA) for select emerging markets in December 2019, and Sandoz AG, Novartis’s generics unit, for the U.S., Europe, Canada, and other regions in a USD 155 million agreement signed in September this year.- Flcube.com
