Amneal Pharmaceuticals Inc. announced that the U.S. FDA is reviewing the Biologics License Application (BLA) for Bevacizumab with a review date expected in the second quarter of 2022 according to the BsUFA (Biosimilar User Fee Act).
The biosimilar was developed in collaboration with mAbxience, a Spain-based biotechnology company. Bevacizumab is the biosimilar version of Avastin® and after approval will be marketed as Alymsys™. Alymsys was approved by the European Medicines Agency (EMA) in February 2021. Amneal and mAbxience believe that the data supports the biosimilarity of its Alymsys™product to Avastin®.
“The FDA’s acceptance of our BLA for Bevacizumab is a significant milestone in our journey to become an important player in biosimilars,” stated Chirag and Chintu Patel, Co-Chief Executive Officers.
Amneal expects its initial biosimilar portfolio will include Filgrastim (biosimilar for Neupogen®), Pegfilgrastim (biosimilar for Neulasta®) and Bevacizumab (biosimilar for Avastin®).
Bevacizumab is a vascular endothelial growth factor inhibitor. 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 also intends to seek approval for the remainder of the indications from the reference product label as soon as possible.
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