Advertisement
03/02/2022

FDA approves biosimilar Neupogen

Releuko is the third biosimilar to Neupogen approved by the Food and Drug Administration, the company said.
Sandra Levy
Senior Editor
Sandra Levy profile picture

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.

[Read more: FDA clears interchangeable insulin biosimilar Semglee]

“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.”

[Read more: Legislation on generics, biosimilars headed to Biden's desk]

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.

[Read More: AAM report: Generics, biosimilars saved U.S. healthcare system $8B in 2020]

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

    Advertisement
    Advertisement