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Home Industry News Hospira receives EU marketing authorisation for Retacrit

Hospira receives EU marketing authorisation for Retacrit

10th January 2008

Hospira has confirmed that it has received marketing authorisation from the European commission (EC) for its biosimilar erythropoietin Retacrit for the treatment of anaemia-associated chronic renal failure and chemotherapy.

The EC announced that it approved Retacrit on the basis of strong and compelling safety and efficacy data as well as recognising the company’s compliance with clinical and non-clinical guidelines.

Michael Kotsanis, president of Europe, Middle East and Africa operations at Hospira, expressed his delight in being able to offer Retacrit to patients and clinicians within Europe.

“As our first marketed biosimilar, Retacrit continues Hospira’s long history of providing high-quality products that also help to reduce healthcare costs,” he added.

Hospira is to kick of its European launch in Germany in early 2008 before expanding its distribution to other European Union countries.

The pharmaceutical company will offer Retacrit in a wide range of pre-filled syringes, with doses ranging from 1,000 to 40,000 international units.

In 2007, Hospira acquired Mayne Pharma, a leading Australian-based speciality injectable pharmaceuticals company, for approximately $2 billion (1 billion pounds).

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