Legislative Background for Marketing Authorisation of the Biosimilar Medical Products in EU


  • Tatyana Benisheva-Dimitrova
  • Petya Trendafilova




Generic, biosimilars, biotechnological and medicinal products, biopharmaceuticals, DDC: 610 (Medicine and health)


The article presents a legislative overview of the medicinal products from biotechnological source, which are derived from living organisms so called biosimilars. Since 2004, based on Directive 2004/27/EC the term “biogeneric” does not exist any more and the therapeutic proteins including, recombinant human insulin for the treatment of diabetes, human growth hormone for the treatment of hypo-pituitary dwarfism, interferon, erythropoietin for the treatment of anaemia in cases of chronic renal failure, various blotting factors referred to an original medicinal products are called ""biosimilars"". All these biological medicinal product often heterogeneous so that modern analytical methodology could not always characterize them in terms of differences in conformation, heterogeneity and impurity profiles. Since 20 November 2005 the Marketing authorization way for biosimilars is via the Centralized Procedure pursuant Regulation (EC) 726/2004, Annex 1. In year 2006-2007 the number of the submitted medicinal product to EMEA is 14. The survey follows and discusses the issues which are necessary for the marketing authorization of all these medicinal products to prove the safety, efficacy and quality, where appropriate pre-clinical tests or clinical trials relating to these conditions must be provided.