FDA accepts application for Adello’s filgrastim biosimilar Posted 06/10/2017

US-based biosimilars specialist Adello Biologics (Adello) announced on 11 September 2017 that the regulatory submission for its proposed filgrastim biosimilar had been accepted by the US Food and Drug Administration (FDA).

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].

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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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Source: Adello

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