As regulators in the USA continue to debate about how to regulate biogeneric drugs, their counterparts in Europe have given the go-ahead to Hospira to sell its copycat version of Johnson & Johnson's anaemia drug Procrit.

Specifically, the European Commission has approved Retacrit (epoetin zeta), a biosimilar erythropoietin, for the treatment of anaemia associated with chronic renal failure (administered intravenously) and chemotherapy. The regulator has decided that the drug has demonstrated comparable efficacy and safety to Procrit (epoetin alfa), which is sold in Europe as Eprex or Erypo, and sales will begin in Germany in early 2008.

Retacrit will be manufactured and distributed under agreements between Hospira, Stada Arzneimittel and Bioceuticals Arzneimittel AG, a former Stada unit that specialises in biosimilars and is now predominantly financed with venture capital. Hospira said the treatment will be sold in a wide range of pre-filled syringes, with doses ranging from 1,000 to 40,000 international units.

Michael Kotsanis, president, Europe, Middle East and Africa for Illinois-based Hospira said the product, the firm’s first biosimilar to get to the market, will “lead the way in establishing a well-tolerated and effective anaemia treatment with significant cost savings". The product is manufactured and packaged in Europe using advanced technology and following Good Manufacturing Practice standards, he said, adding that "healthcare providers and patients can always be confident of Retacrit's quality".

Hospira is benefiting from the European Medicines Agency’s move that developed a regulatory pathway to approve biosimilars in the Old Continent, but a comparable system does not yet exist in the USA. However the biogenerics debate there has heated up in the past six months and the US Congress is “expected to continue to move the issue forward” when it reconvenes in January, Hospira added.

The approval for Retacrit comes some three months after Novartis’ generics unit Sandoz got the go-ahead in Europe to develop its version of epoetin alfa.