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Drug discovery today · Jan 2012
ReviewThe regulatory framework of biosimilars in the European Union.
- Paola Minghetti, Paolo Rocco, Francesco Cilurzo, Vecchio Lucia Del LD, and Francesco Locatelli.
- Department of Pharmaceutical Sciences "P. Pratesi", Università degli Studi di Milano, via G. Colombo, 71-20133 Milan, Italy. paola.minghetti@unimi.it
- Drug Discov. Today. 2012 Jan 1; 17 (1-2): 63-70.
AbstractIn 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.Copyright © 2011 Elsevier Ltd. All rights reserved.
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