Document Detail


The regulatory framework of biosimilars in the European Union.
MedLine Citation:
PMID:  21856438     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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:
Paola Minghetti; Paolo Rocco; Francesco Cilurzo; Lucia Del Vecchio; Francesco Locatelli
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-8-12
Journal Detail:
Title:  Drug discovery today     Volume:  -     ISSN:  1878-5832     ISO Abbreviation:  -     Publication Date:  2011 Aug 
Date Detail:
Created Date:  2011-8-22     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9604391     Medline TA:  Drug Discov Today     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011. Published by Elsevier Ltd.
Affiliation:
Department of Pharmaceutical Sciences "P. Pratesi", Università degli Studi di Milano, via G. Colombo, 71-20133 Milan, Italy.
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