FDA approves pegfilgrastim biosimilar Nyvepria Posted 24/07/2020

Pharma giant Pfizer announced on 11 June 2020 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Nyvepria (HSP-130).

Nyvepria (pegfilgrastim-apgf) is a proposed biosimilar to Amgen’s Neulasta (pegfilgrastim), which had worldwide sales of US$4.7 billion in 2016, before the advent of biosimilars [1]. The patents on Neulasta expired in the US in October 2015 and in Europe in August 2017 [2].

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

Nyvepria is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

The FDA approval of Nyvepria on 10 June 2020 was based on the review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of Nyvepria to its reference product (Neulasta).

According to Ali McBride, Immediate Past President of the Association of Community Cancer Centers (ACCC), ‘chemotherapy-induced febrile neutropenia is a relatively common and severe side effect of some cancer treatments that could cause significant complications and can result in the alteration of treatment regimens’. He added that ‘the FDA approval of Nyvepria provides clinicians with an additional long-acting treatment option that can help prevent infections in patients undergoing myelosuppressive chemotherapy’.

The approval of Nyvepria brings the list of Pfizer’s approved biosimilars up to nine in the US. The company has already gained approval for Abrilada (adalimumab-afzb), Inflectra (infliximab-dyyb), Ixifi (infliximab-qbtx), Nivestym (filgrastim-aafi), Retacrit (epoetin alfa-epbx), Ruxience (rituximab-pvvr), Trazimera (trastuzumab-qyyp) and Zirabev (bevacizumab-bvzr) [3].

Pfizer has also filed its pegfilgrastim biosimilar candidate for regulatory approval with the European Medicines Agency (EMA) and the application is currently under review.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim
2. Derbyshire M, Shina S. Patent expiry dates for best-selling biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US

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Source: Pfizer, US FDA

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