Retacrit(TM) to be the 1st Biosimilar Epoetin to Achieve Subcutaneous Licence in Renal Patients
London, February 22, 2010 (ots/PRNewswire)
Hospira announced today that the European Committee for Medicinal Products for Human Use (CHMP) has recommended for approval the administration of Retacrit (epoetin zeta) subcutaneously in the nephrology setting. This provides an alternative option to intravenous (IV) delivery of the drug for the symptomatic treatment of anaemia associated with chronic renal failure. Final approval by the European Commission (EC) is expected in the next few months, which will result in marketing authorisation for Retacrit subcutaneous (SC) administration in all EU member states.
"As part of Hospira's continued commitment to expand biosimilar options for patients, we are pleased that Retacrit is the first biosimilar epoetin to get a recommendation from the CHMP for subcutaneous administration in the nephrology setting," said Michael Kotsanis, Hospira's President of Europe, Middle East and Africa. "Once approved by the European Commission, 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."
The recommendation for approval of Retacrit SC administration follows the submission of data from a rigorous Phase III clinical trial 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.
Kees Groenhout MD, Vice President of Global Clinical R & D, Hospira, said: "The approval will be a significant step forward, because patients who aren't yet on haemodialysis can be treated with Retacrit at home. Many will also be able to self-inject Retacrit for the first time. For several reasons, subcutaneous administration can conserve hospital resources and save valuable time for patients, too."
The approval has the potential to benefit both healthcare systems and patients across the EU. Cost savings can be made when chronically ill patients learn to self-administer their medication, because they no longer need a visit from (or to) a healthcare professional.
Notes to Editors:
About Retacrit
Retacrit (epoetin zeta) is a biosimilar EPO indicated for the treatment of chemotherapy-induced anaemia, and anaemia associated with chronic renal failure. It is currently licensed for IV administration in nephrology and via the SC route in the oncology setting. SC administration in the nephrology setting has received a positive opinion in Europe, with approval expected in the first half of 2010.
Retacrit(TM) is a trademark of Hospira.
About biosimilars
The introduction of biosimilars such as Retacrit can help provide a more cost-effective option than originator brands and thereby help to reduce healthcare costs in the EU. It has been estimated that biosimilar competition resulting in a 20 percent price reduction in five off-patent biopharmaceuticals could save the EU over EUR1.6 billion per year.(1)
About Hospira
Hospira is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness(TM). As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Illinois, United States and has approximately 13,500 employees. The head office for Hospira in Europe, Middle East and Africa is in Leamington Spa, UK. Learn more at http://www.hospira.com.
Private Securities Litigation Reform Act of 1995 - A Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding certain regulatory approvals and statements regarding Retacrit. Hospira cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, legal, technological and other factors that may affect Hospira's operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Hospira's latest Annual Report on Form 10-K and subsequent Forms 10-Q, filed with the Securities and Exchange Commission, which are incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.
References:
1. European Generic Medicines Association. EGA Handbook on Biosimilar Medicines 2007
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