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.
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