Amneal Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approval of the 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, LLC located in Chicago, Illinois. It is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which is commonly experienced by patients undergoing chemotherapy. Amneal expects to launch Releukotm in the third quarter of 2022, along with a full patient support program.

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.

“The 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. 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-Chief Executive Officers.

“It is a proud moment for the Kashiv Biosciences team and our partners at Amneal to have our first biosimilar, Releuko, approved by the U.S. FDA. Kashiv is one of a few domestic companies to manufacture and launch a biosimilar in the United States. Kashiv aims to continue bringing high quality biosimilars to the global markets over the coming years. I would like to extend a humble thank you to our highly talented team, without whom this would not have been possible,” said Dr. Chandramauli Rawal, Chief Operating Officer for Kashiv.

According to IQVIA, U.S. annual sales for filgrastim for the 12 months ended December 2021 were US $ 407 million, of which US $ 275 million represents biosimilar sales.