FDA accepts Alymsys filing for metastatic colorectal cancer – Amneal Pharma

Amneal Pharmaceuticals announced the FDA has accepted for review the Biologics License Application (BLA) for bevacizumab biosimilar for the treatment of metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment, pursuant to Section 351(k) pathway of the Public Health Service Act, and with a standard review goal date in the second quarter of 2022 according to the BsUFA (Biosimilar User Fee Act).

Bevacizumab is the biosimilar version of Avastin and when approved will be marketed under the proprietary name Alymsys. Alymsys was approved by the European Medicines Agency (EMA) in February 2021. Amneal ( which holds the US rights) and mAbxience believe that the data supports the biosimilarity of its Alymsys product to Avastin.