We use cookies to deliver our online services. Details of the cookies we use and instructions on how to disable them are set out in our Cookies Policy. By using this website you agree to our use of cookies. To close this message click close.

A Model Approach

01 October 2009

Pharmaceutical Marketing Europe
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.

The team

Loading data