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This article describes the relevant European legislation and its anticipated implementation, and following the first approval of a biogeneric drug in Australia. The generic drug market is now firmly established as a major part of the European pharmaceutical sector, with generics forming a significant proportion of off-patent drug sales, especially in Germany, the Netherlands and Great Britain. The European regulatory framework has however been revised in recent years, with provisions that are key to biogeneric approvals due to be brought into effect in late 2005, and it is thought that this new regime could lead to the authorization of the first biogeneric drug in Europe.