13/03/2006 (Agence Europe) - On 8 March, the European Medicines Agency (EMEA) published a set of guidelines on similar biological medicines. These guidelines, which will come into effect from 1st June 2006, define the criteria for gauging the “bio-similarity” of a generic medicines with the medicines of which they are a copy within the framework of the marketing authorisation procedure. EMEA is due to finalise an appendix on epoetin (recombinant human erythropoietin). The finalisation of these guidelines follows an extensive consultation exercise with academia, industry, healthcare professionals and patient groups which began in early 2005. In parallel, EMEA has launched a consultation process, due to end on 1st June 2003, on (1) the comparability of biotechnology-derived medicinal products after a change in the manufacturing process, and (2) the immunogenicity assessment of therapeutic proteins. All of these documents can be found on the EMEA website: http: //http://www.emea.eu.int