A Model Approach

The distinction between generic medicinal products and ‘similar biological medicinal products’ – commonly referred to in the EU as biosimilars – was acknowledged in EU legislation by the 2004 modification of the Community Code on Medicinal (Directive 2001/83/EC). The European Commission (EC) seems to accept that the concept of the ‘generic biologic’ did not exist. It is possible to create a generic of a small molecule medicinal product but not possible, given the nature of biologic products, to create a generic of a biologic. A product that relies on the innovator of the biologic’s data, although it may be similar to that product, will include basic differences. This article discusses EU regulation on biosimilars.

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