Amneal's Avastin-Referred Biosimilar Under FDA Review For Colorectal Cancer

The FDA has accepted for review Amneal Pharmaceuticals Inc's AMRX marketing application seeking approval for Bevacizumab, under Section 351(k) pathway of the Public Health Service Act.
The covers for the treatment of metastatic colorectal cancer, in combination with IV fluorouracil-based chemotherapy for first- or second-line therapy and metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Alymsys-containing regimen.
The goal date would be in the second quarter of 2022.
Bevacizumab is the biosimilar version of Roche Holding AG's RHHBY Avastin and, when approved, will be marketed under the proprietary name Alymsys.
Alymsys was approved by the European Medicines Agency (EMA) in February.
Price Action: AMRX shares are up 1.56% at $5.68 during the market session on the last check Thursday.