To be marketed under the proprietary name fylnetra, pegfilgrastim-pbbk was developed in collaboration with Kashiv Biosciences.
Fylnetra is used for the treatment of neutropenia, a condition that occurs when there are less neutrophils, which are a type of white blood cells that fight infection.
The condition is commonly seen in patients who are undergoing chemotherapy.
The company stated that the regulatory approval marks the third biosimilar approval it received this year for products used in oncology.
Previously, Amneal’s Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen; and Alymsys (bevacizumab-maly), a bevacizumab biosimilar to Avastin were approved.
Amneal co-chief executive officers Chirag and Chintu Patel said: “This is our third US biosimilar approval this year and we are very enthusiastic about our future in the fast growing $28 billion US 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.”
The company expects to launch the three products over the second half of this year, with a full patient support programme.
Kashiv chief operating officer Dr Chandramauli Rawal said: “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 aims to continue bringing high quality biosimilars to the global markets over the coming years.”