Amneal Pharmaceuticals (AMRX) Granted Second US Biosimilars Approval with ALYMSYS

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Biologics License Application (BLA) for bevacizumab-maly, a biosimilar referencing Avastin®. The product will be marketed under the proprietary name ALYMSYS® and represents the third bevacizumab biosimilar approved in the U.S.

ALYMSYS® was developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals. Bevacizumab-maly is a vascular endothelial growth factor inhibitor used in oncology. This marks the second of three biosimilars approvals Amneal expects to receive this year in oncology, the second-largest biosimilar category in the U.S. Earlier this year, Amneal received approval of RELEUKO® (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen®, and the Company’s pegfilgrastim biosimilar referencing Neulasta® is currently under review by the FDA.

“With the U.S. approval of our second biosimilar, ALYMSYS®, we are continuing our momentum and establishing our presence in the $28 billion U.S. biosimilars market. By combining partner assets with our own key capabilities, we are on a clear path to becoming a meaningful player in this high growth category. Biosimilars represent the next wave of affordable medicines in the U.S. and are closely aligned with our strategy to provide high quality, affordable medicines to as many patients as possible,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

“Through our strategic partnership with a market leader like Amneal, we are excited to see this important product enter the U.S. biosimilar market. For us, this is a great example of our globalization strategy materializing and how innovation and cutting-edge R&D technology can be applied to create high quality, affordable medicines that improve access to critical treatments,” said Emmanuelle Lepine, Chief Executive Officer of mAbxience.

According to IQVIA®, U.S. annual sales for bevacizumab for the 12 months ended February 2022 were $2.6 billion, $1.6 billion of which represented biosimilar sales.

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