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The regulatory framework of biosimilars in the European Union

Drug Discovery Today, Volume 17, Issue 1-2, January 2012, Pages 63 - 70

In the European Union (EU), the regulatory policy for biosimilars has enabled different biosimilar products to be marketed through an abridged application, which allows the applicant to submit a reduced dossier. Nevertheless, some manufacturers of biological products that share some characteristics with copies have opted for a full application; therefore, the number and extent of clinical studies required in these cases is increased. Here, we focus on a comparison of recombinant human erythropoietin medicinal products. We analyse and discuss clinical studies submitted to the European Medicines Agency that relate to available biosimilars and biological medicinal products that are authorised with a full dossier. We also discuss the issues of interchangeability and substitution, given that the EU allows each Member State to set their own substitution policies.

Footnotes

1 Department of Pharmaceutical Sciences “P. Pratesi”, Università degli Studi di Milano, via G. Colombo, 71–20133 Milan, Italy

2 Department of Nephrology, Dialysis and Renal Transplant, A. Manzoni Hospital, Via dell’Eremo 9, 23900 Lecco, Italy

Corresponding author:.

1 Article 10(4) and Section 4, Part II, Annex I to Directive 2001/83/EC, as amended by Directive 2007/27/EC.

2 Regulation (EC) No, 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended.

3 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended.

4 Article 10, paragraph 1, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended.

5 Article 10, paragraph 5, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended.