The biosimilar in question is Grastofil (filgrastim), which received approval from the European Medicines Agency on 25 July 2013 [1]. The product is a biosimilar version of Amgen’s originator granulocyte colony-stimulating factor (G-CSF) Neupogen. Grastofil is indicated for the treatment of neutropenia (a low number of white blood cells) caused by cancer chemotherapy. Stada expects to commence sales of Grastofil for nearly all EU countries in 2014.

The agreement with Apotex expands Stada’s biosimilars portfolio by adding ‘a high quality biosimilar at very favourable conditions’, according to Dr Michael Mack, Vice President of Biotechnology at Stada. The partners will use Stada’s international sales structures and comprehensive experience in the European market to market Grastofil.

Grastofil will be available in pre-filled syringes with two different active ingredient concentrations for intravenous or subcutaneous injection. ‘The effectiveness, tolerability and quality of Grastofil are comparable to the original product within the approved area of application,’ explains Dr Mack. ‘This was proven in comprehensive, comparative studies with the original product and has now been confirmed with the approval of the European Commission. With Grastofil, we will be able to offer an inexpensive alternative therapy in the future that doctors, patients and even the public healthcare system will benefit from.’

Sales of filgrastim in Europe in 2011 were Euros 841 million, according to IMS Health.

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – 2013 Q3 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-2013-Q3

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