Amneal Pharmaceuticals enters US biosimilar market with FDA nod for RELEUKOTM

• Amneal Pharmaceuticals (NYSE:AMRX) said the U.S. FDA approved its Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen.
• The product will be marketed under the proprietary name RELEUKOTM.
• RELEUKOTM was developed in collaboration with Kashiv Biosciences in Chicago, Illinois.
• It is used to treat neutropenia (low neutrophils) that is commonly experienced by patients undergoing chemotherapy.
• AMRX expects to launch RELEUKOTM in Q3 of 2022, along with a full patient support program.
• “The U.S. approval of our first biosimilar is a very significant milestone for Amneal. We are building a global biosimilars business by leveraging partner assets to start and then leveraging our own key capabilities over time. Our goal is to become a meaningful long-term player in biosimilars,” said Chirag and Chintu Patel, co-CEOs.
• The company is planning for a pegfilgrastim biosimilar referencing Neulasta and a bevacizumab biosimilar referencing Avastin to launch in 2022. Both are being reviewed by the FDA.

Comments

[GrowthFan]

FDA clearance for a generic bio similar drug opens up a significant new revenue stream for Amneal. We will see how successful they are in entering this significant chemo therapy market. But, the stock AMRX, appears incredibly cheap at this price level.