Kashiv, Amneal Receive First FDA Approval for Their Filgrastim Biosimilar

The FDA has approved Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen developed by Amneal Pharmaceuticals and Kashiv Biosciences. The biosimilar marks the third filgrastim biosimilar to be approved for the US market.

The product is also the first biosimilar to receive FDA approval for the Kashiv and Amneal teams and represents the first FDA biosimilar approval of 2022. The companies said that they expect to launch the product during the third quarter of 2022.

“The US 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 United States. 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 of Amneal, in a statement.

The biosimilar will be used in patients with cancer undergoing chemotherapy who are at risk for developing febrile neutropenia, a common complication related to chemotherapy where the level of neutrophils in a patients’ blood stream are too low.

“It is a proud moment for the Kashiv team and our partners at Amneal to have our first biosimilar, Releuko, approved by the US 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 Chandramauli Rawal, MBBS, chief operating officer for Kashiv, in a statement.

The companies are also working together to develop 2 other oncology biosimilars: a pegfilgrastim biosimilar referencing Neulasta and a bevacizumab biosimilar referencing Avastin. They said they hope to launch them in 2022 and that both are under review by the FDA.

Releuko was approved for administration for intravenous and subcutaneous use, either as single-dose vials or prefilled syringes, both of which come in a 300-mcg/mL dose and 480-mcg/1.6 mL dose.

Under the agreement between Kashiv and Amneal, Kashiv will be handling the US launch and the manufacturing. In January 2021, Amneal and Kashiv announced an agreement under which Amneal would acquire a 98% interest in Kashiv’s specialty pharmaceuticals division. Kashiv Biosciences is headquartered in Piscataway, New Jersey, but has facilities in Chicago, Illinois. Amneal is based in Bridgewater, New Jersey.

Kashiv Biosciences was originally established in 2006 as Therapeutic Proteins, according to founder and consultant for the company, Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars^® Advisory Board. The company’s name was changed in 2014 to Adello Biologics and then to Kashiv Biosciences.

In addition to Releuko, the FDA approved Zarxio (filgrastim-sndz) in March 2015 and Nivestym (filgrastim-aafi) in July 2018. Zarxio was launched in September 2015, and Nivestym has been on the market since October 2018. Zarxio was the first biosimilar approved by the FDA.

Granix (TBO-filgrastim) was approved in August 2012 and launched in November 2013. However, it was approved before the United States had an established biosimilar approvals pathway so it does not count as an official biosimilar.

Under approval of the 351(k) pathway, all biologics, both reference products and biosimilars, approved by the FDA after 2015 will receive a 4-letter suffix added to the nonproprietary drug name, hence why Releuko has the -ayow suffix and the originator filgrastim does not.