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Annals of Oncology Advance Access originally published online on September 14, 2007
Annals of Oncology 2008 19(3):411-419; doi:10.1093/annonc/mdm345
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© The Author 2007. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org

reviews

The challenge of biosimilars

H. Mellstedt1,*, D. Niederwieser2 and H. Ludwig3

1 Cancer Centre Karolinska, Department of Oncology, Karolinska University Hospital Solna, Stockholm, Sweden
2 Department of Hematology and Oncology, University of Leipzig, Germany
3 Department of Medicine, Center for Oncology and Hematology, Wilhelminenspital, Vienna, Austria

* Corresponding author: Professor H. Mellstedt, Department of Oncology, Karolinska University Hospital Solna, SE-171 76 Stockholm, Sweden. Tel: +46-8-5177 4308; Fax: +46-8-31 83 27; E-mail: hakan.mellstedt{at}karolinska.se

Background: The purpose of this report was to review issues associated with the introduction of alternative versions of biosimilars used in the oncology setting.

Design: Data were obtained by searches of MEDLINE, PubMed, references from relevant English-language articles, and guidelines from the European Medicines Agency.

Results: When biosimilars are approved in EU, they will be considered ‘comparable’ to the reference product, but this does not ensure therapeutic equivalence. Inherent differences between biosimilars may produce dissimilarities in clinical efficacy, safety, and immunogenicity. Switching biosimilars should be considered a change in clinical management. Regulatory guidelines have been established for some biosimilar categories but, because of the limited clinical experience with biosimilars at approval, pharmacovigilance programs will be important to establish clinical databases. Guidelines also provide a mechanism for the extrapolation of clinical indications (approved indications for which the biosimilar has not been studied). This may be of concern where differences in biological activity can result in adverse outcomes or when safety is paramount (e.g. stem cell mobilization in healthy donors). These issues should be addressed in biosimilar labeling.

Conclusions: Biosimilars should provide cost savings and greater accessibility to biopharmaceuticals. A thorough knowledge surrounding biosimilars will ensure the appropriate use of biopharmaceuticals.

Key words: biosimilars, substitution, extrapolation, pharmacovigilance, labeling

Received for publication May 29, 2007. Accepted for publication June 4, 2007.


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