Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin) 

 Shots:  The US FDA has accepted the BLA for HLX04, a biosimilar version of Avastin (bevacizumab)  BLA was supported by analytical similarity studies, a P-I PK comparability trial in healthy subjects, and a multicenter P-III trial in pts with metastatic colorectal cancer, evaluating HLX04 vs the reference product for safety, PK, and immunogenicity  Henlius is advancing a P-II/III trial of HLX04 + serplulimab for 1L…