The US Biotechnology Industry Organisation has come out in support of European legislation that it says will require extensive tests to be conducted on so-called 'biosimilar' versions of biological drugs.
The group, which represents the interests of most of the pioneering biotechnology companies, believes the legislation should help protect against copies of biological drugs, the first of which are now facing patent expiries around the world.
Last year, the European Parliament approved new pharmaceutical legislation which, among other things, set out a legal framework for the registration of biosimilars, biological therapies that are similar to existing, approved biological products. But the European Medicines Evaluation Agency must still set out guidelines on the practical implementation of the initiative.
The new EU legislation appears to acknowledge that biosimilars are different from existing biological therapies in terms of their raw materials and manufacturing processes and that even slight differences can alter a biological therapy's safety and effectiveness.
It is notable that the EU has held back from using the more usual term of biogeneric for these agents. The word 'generic' is widely used to denote copies of non-biological drugs - and these need only to show equivalence to the original product. The adoption of the new term suggest that the process will be more complex for biologics.
Some of the biggest-selling biological drugs developed during the first phase of the biotechnology revolution in the 1980s - including human growth hormone (hGH) and insulin - are set to lose patent protection in 2005 and beyond.
Governments are keen to get generic versions approved to reduce the cost burden of these drugs, which tend to be very expensive compared to small-molecule agents. However, the complexity of their manufacture means that it can be difficult to ensure that changes in production will not lead to alterations in the final resulting medicine.
In Europe, the generics company Sandoz has already filed for approval of a generic version of hGH called Omnitrop (somatropin), marking the first generic assault on a market valued at $30 billion and growing at 10 per cent a year.
Meanwhile, Sandoz is gearing up to file for approval of Omnitrop in the US early this year, the country's Food and Drug Administration will probably also have to deal with these issues in the near future. Last year, FDA Commissioner Mark McClellan said that the agency was planning to publish initial proposals on biogenerics 'in the next few months'.