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FDA approves filgrastim biosimilar Nivestym Posted 24/08/2018

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On 20 July 2018, the US Food and Drug Administration (FDA) approved its second filgrastim biosimilar. The filgrastim biosimilar, Nivestym (filgrastim-aafi), is produced by US pharma giant Pfizer.

The product is a proposed biosimilar to Amgen’s Neupogen (filgrastim), which had worldwide sales of US$1.4 billion in 2013 before the approval of the first filgrastim biosimilars [1]. Since then, sales have been reduced by competition from biosimilars. The patents on Neupogen expired in the US in December 2013 and in Europe in 2006 [1].

Filgrastim is a granulocyte colony-stimulating factor (G-CSF). Filgrastim treatment can be used to stimulate the bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy for cancer treatment.

Nivestym has been approved for all eligible indications of the reference product (Neupogen). These include:

  • To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.
  • For reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukaemia (AML).
  • To reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g. febrile neutropenia, in patients with non-myeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
  • For the mobilization of autologous haematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
  • For chronic administration to 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.

FDA approval, according to Pfizer, ‘was based on a review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of Nivestym compared to its reference product’.

The approval of Nivestym marks Pfizer’s fourth biosimilar to be approved by FDA. Inflectra (infliximab- dyyb), Ixifi (infliximab-qbtx) and Retacrit (epoetin alfa-epbx) were approved by FDA in April 2016, December 2017 and May 2018, respectively [2]. Hospira’s Nivestim (filgrastim) was approved in Europe back in June 2010 [3]. Pfizer bought Hospira in 2015 [4].

Pfizer says that its biosimilars pipeline consists of 10 distinct biosimilar molecules with five assets in mid-to-late stage clinical development.

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References
1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars of filgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Aug 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-filgrastim
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Aug 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. Hospira’s biosimilar filgrastim product Nivestim approved [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Aug 24]. Available from: www.gabionline.net/Biosimilars/News/Hospira-s-biosimilar-filgrastim-product-Nivestim-approved
4. GaBI Online - Generics and Biosimilars Initiative. Pfizer sets to lead biosimilars and generics markets [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Aug 24]. Available from: www.gabionline.net/Pharma-News/Pfizer-sets-to-lead-biosimilars-and-generics-markets

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Source: Pfizer, US FDA

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