FDA approves biosimilar Neupogen

The Food and Drug Administration has given the green light to Amneal and Kashiv Biosciences for Releuko (filgrastim-ayow), a biosimilar to Neupogen (filgrastim).

The medication 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.

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“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.”  Chirag and Chintu Patel, co-CEOs of Amneal, said. “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 said it expects to launch Releuko in the third quarter of 2022, along with a full patient support program.

“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,” Chandramauli Rawal, CEO of Kashiv, said. “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.”

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The medication is indicated to:

• Decrease the incidence of infection as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever;
• Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia;
• Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; and
• Reduce the incidence and duration of sequelae of severe neutropenia‚ (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia or idiopathic neutropenia.

Filgrastim had a market value of $407 million, of which $275 million represents biosimilar sales, for the 12 months ended December 2021, according to IQVIA.

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Releuko is the third biosimilar to Neupogen to be approved by the FDA after Zarxio (filgrastim-sndz) and Nivestym (filgrastim-aafi).