Bio-Thera Solutions (SHA: 688177), a biopharmaceutical company based in Guangzhou, has received notification that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of its biosimilar product, Avzivi (bevacizumab), which is a biosimilar version of Roche’s Avastin. The CHMP’s positive recommendation encompasses all existing indications of Avastin, including the treatment of various metastatic cancers such as colorectal, breast, non-small cell lung, renal cell, ovarian, fallopian tube, peritoneal, and cervical.
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 licensed the Greater China rights of its biosimilar to BeiGene in a deal inked in August 2021, valued at up to USD 165 million. The company has also signed licensing agreements for other regions, including 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 September 2021 deal with Switzerland-based Sandoz AG, a generics unit of Novartis, for the US, Europe, Canada, and other regions worth USD 155 million.- Fineline.com
