Amneal Pharmaceuticals, Inc.announced that the U.S. Food and Drug Administration has approved the Company’s Biologics License Applicationfor pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the proprietary name FYLNETRA.
FYLNETRA 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.
This marks the third biosimilar approval Amneal received this year for products used 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 Alymsys® (bevacizumab-maly), a bevacizumab biosimilar referencing Avastin®. Amneal expects to launch these three products over the second half of 2022, along with a full patient support program.
“This is our third U.S. biosimilar approval this year and we are very enthusiastic about our future in the fast growing usd 28 billion U.S. biosimilars market. Biosimilars represent the next wave of affordable medicines and are closely aligned with our mission to provide high quality, affordable medicines to as many patients as possible,” said Chirag and Chintu Patel, Co-Chief Executive Officers.
“Building on our successful partnership with the recent approval of our first biosimilar, Releuko, we are pleased to receive approval for our second biosimilar. Kashiv is one of a few domestic companies to manufacture and launch multiple biosimilars 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 pegfilgrastim for the 12 months ended March 2022 were 3.1 billion, 1.0 billion of which represented biosimilar sales.