Hospira progresses biosimilar Epogen

11 January 2012

USA-based Hospira (NYSE: HSP), a leading provider of generic injectable drugs and infusion technologies, says it has enrolled the first patient in a Phase III US clinical program for its biosimilar erythropoietin (EPO), a follow on to Amgen’s blockbuster Epogen.

Hospira's Phase III program, which follows a successful Phase I trial that concluded last year, will compare safety and efficacy of Hospira's EPO and the reference product, Epogen, in patients with renal (kidney) dysfunction who have anemia. Erythropoietin is a treatment for anemia associated with chronic renal failure.

The program will enroll approximately 1,000 patients on hemodialysis who have already been treated with Epogen, and will take place at more than 200 different hemodialysis centers across the USA. Results are expected in 2013.

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