Benzinga | Jun 17, 2021 10:32AM EDT

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

* The FDA has accepted for review Amneal Pharmaceuticals Inc's (NYSE: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 (OTC: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.