FDA approves biosimilar pegfilgrastim Stimufend

Biosimilars/News | Posted 07/10/2022 post-comment0

On 6 September 2022, Fresenius Kabi announced that they had received approval from the US Food and Drug Administration (FDA) for their pegfilgrastim biosimilar, Stimufend (pegfilgrastim-fpgk).


Stimufend is produced by Fresenius Kabi, the generics unit of German healthcare giant Fresenius. The drug is a biosimilar of Amgen’s Neulasta (pegfilgrastim), a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy [1]

Stimufend is Fresenius Kabi’s first approved US biosimilar. It is a supportive care medicine for patients with non-myeloid cancer. It stimulates the growth of certain white blood cells, which are essential to prevent or fight infections, a common life-threatening risk in patients receiving myelosuppressive chemotherapy.

The approval for Stimufend (pegfilgrastim) is based on a review of a comprehensive data package and a totality of evidence that demonstrated a high degree of similarity with the reference product. No clinically meaningful differences in safety and immunogenicity were observed.

Stimufend received the European Commission’s (EC) marketing authorization in early 2022 [1] and Fresenius Kabi intends to launch its pegfilgrastim biosimilar in a pre-filled syringe in Europe in the fall.

‘The FDA approval of pegfilgrastim biosimilar is an important step to better support the treatment experience and clinical outcomes of cancer patients in the United States’, according to Dr Michael Schönhofen, Fresenius Kabi’s Chief Operating Officer.

FDA has approved Amneal’s pegfilgrastim biosimilar, Fylnetra (pegfilgrastim-pbbk), in May 2022 [2].

More recently, Fresenius Kabi has submitted an application to FDA of its proposed tocilizumab biosimilar (MSB11456) on 1 August 2022 [3].

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1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of teriparatide and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 7]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-teriparatide-and-pegfilgrastim-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves pegfilgrastim and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 7]. Available from: www.gabionline.net/biosimilars/news/fda-approves-pegfilgrastim-and-rituximab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for tocilizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 7]. Available from: www.gabionline.net/biosimilars/news/fda-accepts-application-for-tocilizumab-biosimilar

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Source: Fresenius Kabi

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