FDA Okays a Third Biosimilar to Neupogen


Amneal Pharmaceuticals received approval for Releuko to decrease incidence of infection after chemotherapy.

The FDA approved the third biosimilar to Amgen’s blockbuster cancer treatment Neupogen (filgrastim), which is used to decrease the incidence of infection after treatment for cancer.

Amneal Pharmaceuticals received the nod for its Releuko (filgrastim-ayow), the pharma maker said in a news release. It was developed in collaboration with Kashiv Biosciences.

Sandoz’s Zarxio (filgrastim-sndz), was cleared as FDA’s first ever biosimilar approval in 2015. The second Neupogen biosimilar, Pfizer’s Nivestym (filgrastim-aafi), snagged FDA approval in 2018.

Amneal is expected to significantly benefit from the approval, as the two existing biosimilars netted $275 million in sales in 2021, according to IQVIA. Biosimilars represent a big chunk of annual sales for filgrastim, which hit $407 million total last year, according to IQVIA.

Anthony DiMeo

Anthony DiMeo

“Amneal is excited to bring an American developed and manufactured biosimilar to the U.S. market that will provide choice, access, and potential savings for providers and, most importantly, patients,” Anthony DiMeo, head of investor relations for Amneal, told FormularyWatch®.

Releuko will launch in the third quarter of this year and will be manufactured in Chicago. “We believe this is truly a watershed moment for Amneal and reflects the team’s tireless effort to bring this important oncology biosimilar to market,” DiMeo added.

In addition, the new biosimilar’s wholesale acquisition cost will be in line with the other Neupogen biosimilars on the market, according to DiMeo.

Filgrastim is a granulocyte colony-stimulating factor drug used to prevent or treat chemotherapy induced neutropenia (lower-than-normal levels of white blood cells), commonly experienced by patients undergoing chemotherapy.

Amneal is also planning to launch its pegfilgrastim biosimilar referencing Amgen’s Neulasta and a bevacizumab biosimilar referencing Genentech’s Avastin to launch in 2022. Both are being reviewed by the FDA.

“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,” Amneal Co-Chief Executive Officers Chirag Patel and Chintu Patel said.

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