April 13, 2022
Amneal has received FDA approval for Alymsys® (bevacizumab-maly) intravenous injection, a biosimilar to Genentech’s Avastin® (bevacizumab).
- Alymsys is approved to treat certain patients who have colorectal cancer, non-squamous non- small cell lung cancer, glioblastoma, renal cell carcinoma, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Unlike Avastin, Alymsys is not indicated to treat hepatocellular carcinoma. It is also more limited in its approved use for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Recommended dosing is based on the indication. Alymsys is not approved to be automatically interchangeable with Avastin.
- Launch and pricing information have not been Alymsys is the third Avastin biosimilar to receive FDA approval, with Amgen’s Mvasi® (bevacizumab-awwb) approved in 2017 and Pfizer’s Zirabev® (bevacizumab-bvzr) approved in 2019.