Filgrastim biosimilar has similar safety and efficacy to Neupogen

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Filgrastim biosimilar has similar safety and efficacy to Neupogen

Biosimilars/Research | Posted 23/01/2015 0 Post your comment

A filgrastim biosimilar (EP2006) from Sandoz, the generics division of Swiss pharma giant Novartis, has shown similar safety and efficacy compared to Amgen’s Neupogen (filgrastim) in a pivotal phase III clinical study.

Sandoz announced on 8 December 2014 that phase III data from its PIONEER trial had demonstrated the similarity of its investigational biosimilar filgrastim (EP2006) compared to the US-licensed reference product, Amgen’s Neupogen (filgrastim) in the prevention of severe neutropenia in patients with breast cancer receiving chemotherapy.

The results of the phase III study were presented at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition held in San Francisco, USA, on 6−9 December 2014.

PIONEER was a randomized, double-blind, four-group, multicentre non-inferiority trial conducted at 27 centres in the Czech Republic, Estonia, Germany, Hungary, Latvia, Russia and Slovakia. The trial included 218 women with histologically proven breast cancer receiving neoadjuvant myelosuppressive chemotherapy.

The study also showed that repeated switching at each cycle between the filgrastim biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity.

The US Food and Drug Administration accepted Sandoz’s application for marketing approval of its fligrastim biosimilar in July 2014, as the first biologicals application to be accepted via the abbreviated biosimilars pathway in the US [1]. The company intends to use the results of this trial to support the US registration of its filgrastim biosimilar.

Sandoz already markets its biosimilar filgrastim product, under the brand name Zarzio, in more than 40 countries outside the US [1].

Editor’s comment
It should be noted that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer reviewed journal.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA accepts biosimilar filgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 23]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-biosimilar-filgrastim-application

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Source: ClinicalTrials.gov, Novartis