Big Molecule Watch
March 10, 2022

RELEUKO Receives FDA Approval

Amneal Pharmaceuticals and Kashiv Biosciences have announced that their RELEUKO (filgrastim-ayow) biosimilar recently received FDA approval, making it the third filgrastim biosimilar approved for the United States, as well as the FDA’s first biosimilar approval this year.  RELEUKO references Neupogen®, and is expected to launch in the third quarter of 2022.  RELEUKO is indicated for the treatment of neutropenia experienced by patients undergoing chemotherapy.  It was developed via a collaboration between Amneal and Kashiv, who also anticipate a 2022 approval of a pegfilgrastim biosimilar referencing Neulasta®. Chirag and Chintu Patel, Co-Chief Executive Officers for Amneal, explained that “[t]he U.S. approval of our first biosimilar is a very significant milestone for Amneal. Biosimilars represent the next wave of providing access to affordable medicines in the U.S. Amneal is 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.”

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