28 September 2022 - The approval is based on totality of evidence with no clinically meaningful differences in efficacy or safety with the reference product Avastin (bevacizumab).
Celltrion USA today announced that the US FDA has approved Vegzelma (bevacizumab-adcd), a biosimilar to Avastin (bevacizumab), for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.