The news follows the successful completion of Hospira’s phase I trial, which met its key endpoint in September 2011. The trial showed equal pharmacokinetics, or concentration levels in the blood and distribution in the body, for Hospira’s EPO and the reference product, Amgen’s Epogen [1].

EPO is a treatment for anaemia associated with chronic renal failure. Hospira’s phase III programme will compare the safety and efficacy of Hospira’s EPO with Amgen’s Epogen in patients with anaemia associated with chronic renal (kidney) failure and chemotherapy.

The programme will enrol approximately 1,000 patients on haemodialysis who have already been treated with Epogen at more than 200 haemodialysis centres across the US.

The phase III programme is being conducted in collaboration with DaVita and Fresenius Medical Care, as well as at many dialysis clinics and hospitals across the US.

Dr Sumant Ramachandra, Senior Vice President, Research & Development and Medical & Regulatory Affairs, and Chief Scientific Officer at Hospira, commented that this was ‘another important step as Hospira prepares to introduce safe, effective and affordable biosimilars in the United States’. He added that Hospira is committed ‘to offering US patients access to these important medications’.

Results from the phase III programme are expected in 2013.

Epogen is Amgen’s original blockbuster drug and the engine of much of the company’s sales. According to Wikinvest, Epogen had sales of US$2.5 billion in 2010.

The patent on Epogen expired in Europe in 2004, with the US patent expected to expire in 2014 [2].

Hospira already sells a biosimilar EPO in Europe, Retacrit, making it the first US-based company with biosimilars on the European market. Retacrit, introduced in 2008, now has a more than 50% share of the total short-acting EPO biosimilar market in Europe. Hospira also launched Nivestim, a biosimilar version of filgrastim, in Germany, Ireland and the UK, in 2010. Filgrastim is a granulocyte colony-stimulating factor (G-CSF) used to treat neutropenia, a condition in which the body makes too few infection-fighting white blood cells. The condition is often caused by drugs prescribed for cancer treatment.

Hospira therefore has much to gain by being ready with a biosimilar EPO by 2014 when, hopefully, the US biosimilars pathway should be in place.

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Australia approves first biosimilar filgrastim

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References

1. GaBI Online - Generics and Biosimilars Initiative. Positive results for Phase I trial of biosimilar erythropoietin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Biosimilars/News/Positive-results-for-phase-I-trial-of-biosimilar-erythropoietin

2. GaBI Online - Generics and Biosimilars Initiative. Market opportunities for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Biosimilars/General/Market-opportunities-for-biosimilars