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Hospira launches first biosimilar in EU

Hospira wins EU Commission approval for its generic version of Amgen and Johnson & Johnson's biotech anaemia drug, Procrit

US-based hospital products company Hospira has won EU Commission approval for its generic version of Amgen and Johnson & Johnson's biotech anaemia drug, Procrit (epoetin alfa).

Hospira's drug, which will be marketed as Retacrit, is the company's first bio-similar approved by EU regulators.

Biosimilars are manufactured using living organisms, just as the original version of a biotech drug is made, but as the process involves biological processes, whether or not the biogeneric is exactly the same as the original product is unclear.

In the US, the government continues to debate how to regulate bio-generic drugs. One of the most controversial issues is proposals regarding the process used to copy the original product. The European Medicines Agency (EMEA) has already developed a process for regulating bio-generic drugs.

Hospira said it will launch Retacrit in early 2008. Procrit is known as Eprex or Erypo in Europe.

Retacrit is being manufacturerd and distributed under agreements with Hospira, German generic drug developers Stada and Bioceuticals.

Lower sales anaemia drugs in the US were caused by a decline in the market related to a labelling change made in March 2007 and a decision memorandum issued by the Centers for Medicare & Medicaid Services under its national coverage analysis process. 

So far in 2007, Procrit sales in the US for J&J were down 27 per cent to rest at USD 380m, compared with USD 522m for the previous year. International sales for the biologic rose nine per cent to USD 302m in 2007, however. Total sales were down 14.6 per cent to USD 682m.

20th December 2007

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