The National Medical Products Administration (NMPA) website indicates that China-based Shanghai Henlius Biotech’s (HKG: 2696) HLX04, a biosimilar version of Swiss giant Roche’s Avastin (bevacizumab), has been approved for use in advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), and metastatic colorectal cancer (CRC). Henlius’s drug becomes the eighth home-grown bevacizumab biosimilar on the market in China.
Avastin’s Regulatory History
Avastin won its first global approval in the United States in February 2004, and has chalked up six indication nods in China: CRC, first-line NSCLC, glioblastoma, hepatocellular carcinoma, first-line epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, and cervical cancer.
Other Biosimilar Approvals
In December 2019, Qilu Pharma’s biosimilar version of bevacizumab won a first-mover approval, indicated for NSCLC and CRC. Meanwhile, Innovent Bio, Luye Pharma, Hengrui Medicine, Bio-Thera Solutions, Betta Pharma, and Tot Bio are the other companies with biosimilar approvals, Tot Bio’s awarded earlier this week.-Fineline Info & Tech
