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Apotex breaking into the North American and European G-CSF markets Posted 23/08/2013

A new biosimilar filgrastim is poised to enter the important granulocyte colony-stimulating factor (G-CSF) market following a positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP).

The G-CSF analogue filgrastim and its biosimilars are widely used to treat the common and potentially life-threatening side effect of cancer chemotherapy – neutropenia. The drop in neutrophil numbers associated with neutropenia leaves patients dangerously immunocompromised and susceptible to otherwise mild bacterial infections.

On 25 July 2013, EMA’s CHMP issued a positive opinion for a new filgrastim biosimilar from Apotex Europe: Grastofil, 30 MU/0.5 mL and 48 MU/0.5 mL, solution for injection or infusion for the treatment of neutropenia. Grastofil is a biological medicinal product similar to the reference product Neupogen (Amgen), which is already authorized in the EU. Grastofil has demonstrated comparable quality, safety and efficacy with the reference product.

The news follows collaboration between Apotex and India-based Intas Biopharmaceuticals (Intas) to develop the biosimilar filgrastim Neukine. Neukine was already manufactured and marketed in India and other countries by Intas before the collaboration, and Kwizda Pharma of Austria had been working with Intas to develop G-CSF for the European market. In 2008, Kwizda Pharma transferred all of its rights from the Intas G-CSF biosimilar to Apotex. Apotex and Intas extended their collaboration to development of G-CSF for North America (US and Canada).

There are now several filgrastim biosimilars in the EU, including Biograstim, Filgrastim Hexal, Nivestim, Ratiograstim and Tevagrastim. A recent study concluded that biosimilar filgrastim was relatively cost saving compared to both originator filgrastim (Neupogen, Amgen) and pegfilgrastim (Neulasta, Amgen) [1].

In August 2013, EMA granted marketing authorization for a new recombinant G-CSF: Teva Pharmaceutical Industries' Lonquex (lipegfilgrastim). Lonquex is a long-acting recombinant G-CSF with the active ingredient lipegfilgrastim – a novel glycoPEGylated (PEG; polyethylene glycol) filgrastim molecule [2].

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References

1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilar filgrastim provides cost savings for treating febrile neutropenia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Aug 23]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-filgrastim-provides-cost-savings-for-treating-febrile-neutropenia

2.  GaBI Online - Generics and Biosimilars Initiative. EMA approval for biosimilar long-acting recombinant G-CSF [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Aug 23]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-Teva-s-long-acting-recombinant-G-CSF

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Source: Apotex, EMA, Teva

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