Teva launches new biologicals in Europe and US

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Teva launches new biologicals in Europe and US

Biosimilares/Novedades | Posted 13/12/2013 0 Post your comment

Teva Pharmaceutical Industries (Teva) announced on 18 November 2013 the first EU launch for its new long-acting filgrastim molecule Lonquex (lipegfilgrastim) in Germany and the launch of its short-acting granulocyte colony-stimulating factor (G‑CSF) Granix (tbo-filgrastim) in the US.

G-CSF increases the production and function of neutrophils (a type of white blood cell) in the blood. It is therefore used for the treatment of chemotherapy-induced neutropenia (a low number of neutrophils).

Teva launched Lonquex (long-acting G-CSF) in Germany on 4 November 2013, in what the company says is the first launch as part of a European Union (EU)-wide approval. Lonquex received marketing approval from the EU on 25 July 2013. Teva plans to continue the roll-out of Lonquex across additional countries covered by the European approval over the coming months.

Lonquex is expected to compete with Amgen’s blockbuster drug Neulasta (pegfilgrastim) and will be dosed in the same way (as a single subcutaneous injection once per chemotherapy cycle). Lonquex was shown to be non-inferior to Neulasta in trials, although there was no evidence of advantages over the Amgen drug [1].

Teva launched Granix (short-acting G-CSF) in the US on 11 November 2013, marking the entry of the first new G-CSF to the US market in more than 10 years. Teva received US Food and Drug Administration (FDA) for Granix on 29 August 2012.

Teva currently markets filgrastim in Europe under the trade name Tevagrastim, a biosimilar of Amgen’s Neupogen (filgrastim). Tbo-filgrastim was filed in the US as a Biologics License Application (BLA) since a biosimilars approval pathway had not been established at the time of submission.

Lonquex and Granix provide new treatment options for physicians who are seeking to reduce the duration of severe neutropenia in patients with non-myeloid malignancies, who are receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Teva says that it is ‘committed to commercializing G-CSFs globally and is continuing to build the portfolio of short- and long-acting G-CSFs in this important, patient-focused category of medicines’. The company, however, recently suffered a setback in this area, with the withdrawal of its BLA for balugrastim from the US Food and Drug Administration (FDA) review process [2].

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Teva receives FDA approval for filgrastim in the US

Delays in FDA approval of biosimilar G-CSF (filgrastim)

References

1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for Teva’s long-acting recombinant G-CSF [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Dec 13]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-Teva-s-long-acting-recombinant-G-CSF

2. GaBI Online - Generics and Biosimilars Initiative. Copaxone stay rejected and balugrastim withdrawn [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Dec 13]. Available from: www.gabionline.net/Biosimilars/News/Copaxone-stay-rejected-and-balugrastim-withdrawn

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Source: EMA, FDA, Teva