Phase I trial of a biosimilar erythropoietin

Biosimilars/Research | Posted 25/08/2010 post-comment0 Post your comment

A Phase I clinical trial of Hospira’s biosimilar erythropoietin (EPO) in patients with anaemia associated with chronic renal failure and chemotherapy has started in the US.


The goal of the trial is to test safety and pharmacokinetics compared with the reference product and is taking place at 20 haemodialysis centres across the US. Patients in the trial will be treated with both Amgen’s Epogen and Hospira’s EPO, in a cross-over design.

The Phase I study is being conducted in collaboration with DaVita, and Fresenius Medical Care. Although Phase I trials are normally conducted with healthy volunteers, Hospira received US FDA approval to conduct this trial with patients.

Pending successful completion of the Phase I trial, Hospira intends to launch an expanded Phase III trial in 2011.

Dr Sumant Ramachandra, Senior Vice President, Research & Development and Medical & Regulatory Affairs, and Chief Scientific Officer, Hospira, commented that “this trial marks a key milestone for Hospira’s biosimilars program”, adding “we hope to leverage our leadership in generics and our biosimilars experience in Europe to make affordable, safe and effective biosimilars available to US patients”.

Hospira already sells a biosimilar EPO in Europe, Retacrit, and is 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 recently launched Nivestim, a biosimilar version of filgrastim, in Germany, Ireland and the UK. Filgrastim is a granulocyte colony-stimulating factor 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.

With a growing number of patents for biopharmaceuticals expiring, Hospira has been quick to see the potential opportunities. The company has responded by significantly expanding its ability to develop, manufacture and market biosimilars, and currently has one of the largest biosimilar pipelines in the industry.


Hospira News Release. Hospira Begins Phase I U.S. Clinical Trial of Biosimilar Erythropoietin in Renal Patients. 26 July 2010.

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