Shanghai Henlius Biotech Inc. (HKG: 2696) announced that a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of Roche’s Avastin (bevacizumab), has been accepted for review by the Center for Drug Evaluation (CDE). The targeted indication is hepatocellular carcinoma (HCC).
Drug Background
HanBeiTai is also awaiting a regulatory decision for use in recurrent glioblastoma (GBM). The drug was first approved in China in November of last year to treat advanced, metastatic, or recurrent non-small cell lung cancer and metastatic colorectal cancer. Avastin was first approved in the United States in February 2004 and entered China in February 2010. It was included on the National Reimbursement Drug List (NRDL) in 2017.
Market Context
In addition to Henlius Pharma, a total of 8 other companies, including Qilu Pharma, Innovent Bio, Hengrui Medicine, Bio-Thera Solutions, Betta Pharma, and Tot Bio, all have biosimilar versions of Avastin on the local market.-Fineline Info & Tech
