The first copycat versions of biotech medicines could be approved in Europe later this year, while the United States is unlikely to get them before 2009, according to a report on 17 th January, 2006.

Independent consultancy Datamonitor said the European Union was making real progress in drawing up rules for biogeneric, or biosimilar, drugs.

But the U.S. is lagging notably behind, with opposition from the branded industry exerting a much greater influence and slowing down regulatory reforms.

The European Medicines Agency said last month it expected to receive eight biogeneric marketing applications in 2006. At the end of 2005, it had three.

Datamonitor predicts the five key players in the biogeneric space will be Novartis AG's Sandoz; Teva Pharmaceutical Industries Ltd; BioPartners; ratiopharm, through its subsidiary BioGenerix; and Stada Arzneimittel AG, through its affiliate Bioceuticals.

Biogenerics could eventually undermine profits for biotechnology companies in the same way that copies of small-molecule drugs have hurt mainstream pharmaceutical makers -- especially since the high cost of biotech drugs makes them a prime target for cost-cutting measures.

Datamonitor estimates sales of biotech drugs by 56 of the world's top drug makers rose 18.3 percent to $56.2 billion in 2004. Of this total, $20.2 billion was derived from six product classes at immediate risk from biogenerics -- insulin, human growth factor, erythropoietinepoetin, colony stimulating factors, interferon alpha and interferon beta.

Yet the nature of biologic medicines rules out exact generic copies and introduces additional complexity and expense into all stages of biogeneric development.

Makers of branded medicines say comprehensive clinical studies are needed to assess the safety of biogenerics in patients. The generic industry, keen to avoid costly patient studies, wants to keep additional tests to a minimum.

In Europe, a compromise of a full preclinical data package and relatively small clinical trials appears to have been accepted. But in the U.S. the branded industry is still campaigning hard for tighter safety controls.

The arrival of biogenerics could hit a number of big pharmaceutical groups, but it is likely to be felt most acutely by specialist companies.

Merrill Lynch analysts said in a recent note the threat of generic insulin could weigh on sentiment for Denmark's Novo Nordisk in the near term, since sales of human insulin in Europe represent around 20 percent of its total sales.

(http://today.reuters.co.uk)