Hospira's Retacrit receives Marketing Authorisation in the EU

4-Jan-2008

The European Commission has authorised US company Hospira, a world leader in generic injectable pharmaceuticals, to market Retacrit (epoetin zeta), a biosimilar erythropoietin, for the treatment of anemia associated with chronic renal failure (administered intravenously) and chemotherapy.

The European Commission has authorised US company Hospira, a world leader in generic injectable pharmaceuticals, to market Retacrit (epoetin zeta), a biosimilar erythropoietin, for the treatment of anemia associated with chronic renal failure (administered intravenously) and chemotherapy.

Hospira will launch the product in various EU countries, beginning with Germany early this year.

The product is manufactured and packaged in Europe using advanced technology and following GMP standards. Hospira will offer Retacrit in a wide range of convenient pre-filled syringes, with doses ranging from 1,000 to 40,000 IU.

It is being developed, manufactured and distributed under agreements between Hospira, STADA Arzneimittel and BIOCEUTICALS Arzneimittel, a STADA-initiated company.

"Retacrit will lead the way in establishing a well-tolerated and effective anaemia treatment with significant cost savings," said Michael Kotsanis, president, Europe, Middle East and Africa, Hospira.

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The European Medicines Agency (EMEA) has developed a regulatory pathway to approve biosimilars in Europe, but a comparable FDA approval pathway does not yet exist in the US, where the products are often referred to as "follow-on proteins" or "biogenerics". The US Congress is expected to continue to move the issue forward when it reconvenes in January.

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