title: The regulatory framework of biosimilars in the European Union.
abstract: 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.
authors.affiliation: Department of Pharmaceutical Sciences "P. Pratesi", Università degli Studi di Milano, via G. Colombo, 71-20133 Milan, Italy. paola.minghetti@unimi.it
authors.forename: Paola
authors.initials: P
authors.lastname: Minghetti
authors.forename: Paolo
authors.initials: P
authors.lastname: Rocco
authors.forename: Francesco
authors.initials: F
authors.lastname: Cilurzo
authors.forename: Lucia Del
authors.initials: LD
authors.lastname: Vecchio
authors.forename: Francesco
authors.initials: F
authors.lastname: Locatelli
mesh_terms: D001688:Biological Products / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005062:European Union; D006801:Humans
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals