BRUSSELS, Belgium - The trickle of biosimilars winning approval in Europe continues to grow. In line with recent predictions from the European Medicines Agency (see BioWorld International Oct. 17, 2007) Europe's senior scientific committee gave the green light to two further generic biotech products, copies of epoetin zeta, at its October meeting.

The agency's Committee for Medicinal Products for Human Use adopted positive opinions for Stada Arzneimittel's Silapo and Hospira Enterprises' Retacrit in treatment of anaemia associated with chronic kidney disease and in oncology patients to treat anemia and reduce blood-transfusion requirements, as well as to increase the yield of autologous blood in a pre-donation program.

The committee ruled that both products had been shown to be similar to Johnson & Johnson's Eprex/Erypo, the reference product already authorized in the European Union for these indications. Regulatory assessment of Retacrit began only on May 20 this year, a review time of just 85 days. The authorization process for these two biosimilars will be completed as soon as the EU formal stamp of approval is granted on the basis of the committee's recommendations.