A Phase I clinical trial of Hospira’s biosimilar erythropoietin (EPO) has begun in the US to treat anaemia associated with chronic renal failure and chemotherapy.
The Phase I study will test the safety and pharmacokinetics of the drug’s blood level and distribution in patients with anaemia and renal dysfunction, compared with the reference product.
The randomised trial will treat patients with both Amgen‘s Epogen and Hospira’s EPO, with each patient receiving one drug first and the other later.
Hospira said it will launch an expanded Phase III trial in 2011 after the successful completion of the Phase I trial.
The Phase I study is being conducted by Hospira in collaboration with DaVita and Fresenius Medical Care AG & Co at 20 haemodialysis centres across the US.