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Biosimilar shows “no additional safety concerns”


Hospira, the world leader in generic injectable pharmaceuticals, today presented combined safety and immunogenicity data from two pivotal Phase III trials used to gain marketing authorisation for Retacrit in the European Union.

The data, presented at the Annual European Renal Association and European Dialysis and Transplant Association Congress (ERA-EDTA), confirm that the safety, efficacy and immunogenicity of Retacrit (epoetin zeta) are comparable to that of epoetin alfa (Erypo) in patients with end-stage renal failure (ESRF).

Retacrit is a biosimilar erythropoietin approved in Europe for the treatment of anaemia associated with chronic renal failure (administered intravenously) and chemotherapy (administered subcutaneously).

Safety, efficacy and potential immunogenicity data were evaluated in two substantial Phase III clinical trials. The trials compared Retacrit with Erypo, the reference product, in the correction and maintenance phases of renal anaemia.

Professor Paul Scigalla of International Clinical Research Consulting (ICRC) said: “The data show there are no additional safety concerns linked to the administration of Retacrit compared with Erypo, and no patients developed neutralising anti-erythropoietin antibodies or pure red blood cell aplasia (PRCA) during the course of the trials.

“Retacrit may provide an alternative treatment with equivalent clinical benefits and greater cost-effectiveness for patients with this chronic condition.”

Hospira today also announced the launch of Retacrit in the UK for the treatment of anaemia associated with chronic renal failure (administered intravenously) and chemotherapy.


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