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.

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. The patents on Neupogen expired in the US in December 2013 and in Europe in 2006 [1].

The biosimilar application for Adello’s filgrastim biosimilar is ‘supported by similarity data from analytical, pre-clinical and clinical development studies, comparing the biosimilar candidate to Neupogen’. The company also has adalimumab and pegfilgrastim biosimilars in preclinical and clinical development, respectively, and is carrying out a phase I trial for its pegfilgrastim biosimilar [2].

Sandoz’s filgrastim biosimilar Zarxio was the first biosimilar to be approved in the US in September 2015 [3].

Related articles
Biosimilars approved in the US

Biosimilars of filgrastim

References
1. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
2. GaBI Online - Generics and Biosimilars Initiative. Adello Biologics starts phase I trial for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 6]. Available from: www.gabionline.net/Biosimilars/Research/Adello-Biologics-starts-phase-I-trial-for-pegfilgrastim-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Zarxio first biosimilar to be launched in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 6]. Available from: www.gabionline.net/Biosimilars/News/Zarxio-first-biosimilar-to-be-launched-in-US

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