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Hospira starts US trials of biosimilar EPO

Erythropoietin to be compared to Amgen’s Epogen for safety and efficacy having already demonstrated equivalence in pharmacokinetics

Generic drugmaker Hospira has started phase III testing of its biosimilar erythropoietin (EPO) product.

The company says it has enrolled its first patient for an initial phase III trial in the US, which will aim to compare the safety and efficacy of biosimilar EPO to its reference product, the Amgen drug Epogen (epoetin alfa).

The company has already completed a phase I study which showed that its biosimilar EPO was equivalent to Epogen in terms of its pharmacokinetics. EPO is a treatment for anaemia associated with chronic renal failure.

Hospira already sells a biosimilar EPO in Europe under the Retacrit brand, a product which has been available since early 2008.

It is the only US company selling biosimilars in Europe, where the regulatory route for securing approval of equivalent versions of biologic drugs is more established than in the US.

"With a growing number of patents for biopharmaceuticals expiring in the US and around the globe, Hospira has significantly expanded its comprehensive competencies to develop, manufacture and market biosimilars, and has one of the largest biosimilar pipelines in the industry," said the company in a statement.

Hospira also sells biosimilar versions of the white blood cell treatment filgrastim, which it sells as Nivestem in Europe and Australia.

The US programme will enrol around 1,000 patients on haemodialysis who have already been treated with Epogen, and will take place at more than 200 different haemodialysis centres across the US. Results are expected in 2013.

Epogen has been a major success for Amgen but sales are being hit by generic competition, as well as a recent decision by Medicare to raise the red blood cell count threshold for initiating treatment with EPO.

Analysts have estimated that sales of the drug will slide 20 per cent to around $2bn in 2011.

Amgen has responded to the pressure by trying to lock dialysis clinics into long-term supply contracts. Earlier this year the company signed a seven-year agreement with DaVita which will see Epogen used to meet 90 per cent of its EPO requirements.

12th January 2012

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