Long-acting G-CSF lipegfilgrastim launched in UK

Biosimilars/News | Posted 21/03/2014 post-comment0 Post your comment

Teva UK, a subsidiary of generics giant Teva Pharmaceutical Industries (Teva) announced on 24 February 2014 the launch of its long-acting granulocyte colony-stimulating factor (G‑CSF) Lonquex (lipegfilgrastim) in the UK.

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G-CSF increases the production and function of neutrophils (a type of white blood cell) in the blood. Lonquex is indicated for the reduction of the duration of neutropenia (a low number of neutrophils) and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Lipegfilgrastim is a novel glycopegylated (PEG; polyethylene glycol) filgrastim molecule. Because it is ‘glycopegylated’ (rather than peglyated) polymer chains are added to the active protein that are distant from the active site. In theory, this should prevent variations in the activity of the drug molecule and increase its structural homogeneity.

Lonquex has been shown to be non-inferior to Amgen’s blockbuster drug Neulasta and will be dosed in the same way (as a single subcutaneous injection once per chemotherapy cycle) [1].

Lonquex has undergone a full clinical development programme as part of the efficacy and tolerability assessment for use with chemotherapy patients. Teva received European Medicines Agency (EMA) approval for Lonquex on 25 July 2013 and launched the product in Germany on 4 November 2013 [1]. The company reports that it has also launched the product in Ireland and The Netherlands, and the UK launch is part of a Europe-wide market launch.

Teva UK is the largest supplier of medicines to the UK’s National Health Service and has had a presence in the UK market for over 75 years.

Related article

EMA approval for Teva’s long-acting recombinant G-CSF

Reference

1.   GaBI Online - Generics and Biosimilars Initiative. Teva launches new biologicals in Europe and US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 21]. Available from: www.gabionline.net/Biosimilars/News/Teva-launches-new-biologicals-in-Europe-and-US

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Source: Teva UK

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