First Subcutaneous Biosimilar Approved for Renal Patients

22 February 2010 (Last Updated February 22nd, 2010 18:30)

The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the administration of Hospira's Retacrit (epoetin zeta) subcutaneously for the treatment of renal failure. Once approved by the European Commission (EC), Retacrit will become the first biosimi

The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the administration of Hospira's Retacrit (epoetin zeta) subcutaneously for the treatment of renal failure.

Once approved by the European Commission (EC), Retacrit will become the first biosimilar epoetin (EPO) to provide an alternative option to intravenous (IV) delivery of the drug.

Hospira president of Europe, Middle East and Africa Michael Kotsanis said that once approved by the EC, Retacrit will be suitable for subcutaneous as well as intravenous administration in the nephrology setting.

"This will give clinicians greater flexibility in managing symptomatic anaemia in their renal patients and provide healthcare professionals with a cost-effective alternative to originator epoetins," Kotsanis said.

Final approval by the EC is expected in the next few months, which will result in marketing authorisation for Retacrit subcutaneous (SC) administration in all EU member states.

The recommendation for approval of Retacrit SC administration follows the submission of data from successful Phase III clinical trials demonstrating comparable efficacy and safety between epoetin zeta and the reference product, epoetin alfa, when administered subcutaneously in patients with end-stage renal failure on chronic haemodialysis.