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news.Hospira has initiated a Phase I clinical trial of its biosimilar erythropoietin (EPO) in patients with renal (kidney) dysfunction who have anemia, an important step on the road toward introducing a biosimilar product in the US.
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Hospira said that Erythropoietin is a treatment for anemia associated with chronic renal failure and chemotherapy.
The controlled, randomised trial of patients on hemodialysis who have already been treated with Amgen’s Epogen (epoetin alfa), is taking place at 20 different hemodialysis centers across the US.
Reportedly, the patients in the trial are expected to be treated with both Epogen and Hospira’s EPO, with each patient receiving one drug first and then being switched to the second drug.
The Phase I trial is to test safety and pharmacokinetics, or measurements of the drug’s blood level and distribution in the body, compared with the reference product.
Sumant Ramachandra, senior vice president of R&D and medical & regulatory affairs, and chief scientific officer at Hospira, said: “This trial marks a key milestone for Hospira’s biosimilars program. Congressional approval of a regulatory pathway for biosimilar drugs in the US set the stage for our development of a US biosimilar EPO.”