Amneal Announces FDA Acceptance of aBLA for Bevacizumab

Amneal Pharmaceuticals, Inc., a fully integrated pharmaceutical company headquartered in Bridgewater, NJ, announced last week that the U.S. FDA has accepted its aBLA seeking approval of a biosimilar of Avastin® (bevacizumab).  This biosimilar was developed in collaboration with Spain-based biopharmaceutical company mAbxience, which had obtained approval earlier this year to market its bevacizumab biosimilar in Europe.  According to Amneal’s press release, “Amneal is seeking approval for Bevacizumab for the treatment of metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment 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.”

Amneal’s Co-Chief Executive Officers stated that the “FDA’s acceptance of our BLA for Bevacizumab is a significant milestone in our journey to become an important player in biosimilars.”  This filing represents Amneal’s third biosimilar application, after filgrastim (biosimilar for Neupogen®) and pegfilgrastim (biosimilar for Neulasta®).