Amneal Launches Bevacizumab Biosimilar in the United States

Yesterday, Amneal Pharmaceuticals, Inc. announced the launch of its first biosimilar in the United States:  ALYMSYS (bevacizumab-maly), a biosimilar referencing Genentech’s AVASTIN product.  ALYMSYS is a vascular endothelial growth factor inhibitor approved by the FDA in April 2022 for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma in adults, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.  As we previously reported, Amneal’s biosimilar was developed in collaboration with Spain-based biopharmaceutical company mAbxience.

According to Co-Chief Executive Officers Chirag and Chintu Patel, “Amneal has officially entered the U.S. biosimilar market.  Beyond these initial launches, we are working to expand our biosimilars portfolio with additional molecules where we can be early to market and vertically integrate over time.  Biosimilars represent the next wave of affordable medicines and are closely aligned with our mission to provide high quality, affordable medicines to as many patients as possible.”