Discussion
nausea, diarrhea, headache, ovarian failure, hypokalemia
HYPERTRIGLYCERIDEMIA, UPPER RESPIRATORY TRACT INFECTION, OVARIAN FAILURE
In this study, the recombinant humanized anti-VEGF monoclonal antibody injection and Avastin® had similar PK, clinical safety, and immunogenicity characteristics after a single intravenous infusion.The test drug and the reference drug had similar mean serum concentration-time profiles. The 90% CIs of the GMR of AUCThe PK of bevacizumab was linear between 1 and 10 mg/kg [According to associated guidelines [The most common AEs reported in previous studies on bevacizumab biosimilars performed in healthy subjects were headache, nasopharyngitis, pharyngitis, upper respiratory tract infection, hypertriglyceridemia, hypokalemia, nausea, and diarrhea [Throughout the study, the incidence of ADAs was low and comparable in both groups, with only 1 of 44 subjects in the test group and 2 of 43 subjects in the reference group testing positive for ADAs. The results of the NAb tests were all negative. The lower incidence of immunogenicity observed in this study was in line with other studies on bevacizumab biosimilars and product characteristics [Overall, the laboratory results and other safety measures were unremarkable, and we identified no safety concerns. There were no clinically significant differences with respect to laboratory tests, vital signs, and ECGs between the treatment groups. Because bevacizumab was administrated at a low subtherapeutic dose in healthy subjects, the study’s safety results are only helpful for comparison.One of the study’s limitations is that the study population is radically and ethnically homogenous. Only Chinese male subjects were selected, with Han nationality accounting for 97.73%. Another limitation is that the subjects only received a single injection of the recombinant humanized anti-VEGF monoclonal antibody injection or Avastin®. However, the PK data from this trial’s single administration will provide a foundation for further studies. A phase III study with multiple doses in larger patient population is required to further develop recombinant humanized anti-VEGF monoclonal antibody injection. Furthermore, previous studies have shown that gender influenced test results, and bevacizumab increased the risk of ovarian failure in women and might impair female fertility [