Sandoz resubmits pegfilgrastim biosimilar to FDA

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Sandoz resubmits pegfilgrastim biosimilar to FDA

Biosimilares/Novedades | Posted 05/04/2019 0 Post your comment

Sandoz, the generics division of Novartis, announced on 3 April 2019 that the regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the US Food and Drug Administration (FDA).

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.

Sandoz first applied for FDA approval for its proposed pegfilgrastim biosimilar LA-EP2006 back in November 2015 [1]. However, FDA rejected the application in July 2016 [2].

The original application included data from three pivotal clinical trials [1], but Sandoz says that this time it has included new data from a pivotal pharmacokinetics (PKs) and pharmacodynamics (PDs) study. This new study was a single-dose, three-period cross-over study comparing LA-EP2006 with US-sourced reference pegfilgrastim; with EU-sourced reference pegfilgrastim; and US with EU-sourced reference pegfilgrastim.

Sandoz already gained approval in Europe for its pegfilgrastim biosimilar Ziextenzo (LA-EP2006) in November 2018 [3]. The company has three approved biosimilars in the US [4] and markets eight biosimilars in Europe (including Ziextenzo) [5].

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 5]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA rejects Sandoz’s biosimilar pegfilgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 5]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Sandoz-s-biosimilar-pegfilgrastim-application
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for pegfilgrastim biosimilars Pelmeg and Ziextenzo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 5]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-pegfilgrastim-biosimilars-Pelmeg-and-Ziextenzo
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Sandoz