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.
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