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NDT Plus 2009 2(Supplement 1):i27-i36; doi:10.1093/ndtplus/sfn177
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© The Author [2009].
The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that: the original authorship is properly and fully attributed; the Journal and Oxford University Press are attributed as the original place of publication with the correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact journals.permissions@oxfordjournals.org

This article appears in the following NDT Plus issue: Key Insights into Present and Future Treatments of Anaemia in CKD Patients [View the issue table of contents]

Biosimilar therapeutics—what do we need to consider?

Huub Schellekens

Departments of Pharmaceutical Sciences and Innovation Studies, Utrecht University, Utrecht, The Netherlands

Correspondence: Huub Schellekens, Departments of Pharmaceutical Sciences and Innovation Studies, Utrecht University, Utrecht, The Netherlands. Tel: +31-30-253-3831; Fax: +31-30-251-0964; E-mail: h.schellekens{at}uu.nl


  Abstract

Patents for the first generation of approved biopharmaceuticals have either expired or are about to expire. Thus the market is opening for generic versions, referred to as ‘biosimilars’ (European Union) or ‘follow-on protein products’ (United States). Healthcare professionals need to understand the critical issues surrounding the use of biosimilars to make informed treatment decisions.

The complex high-molecular-weight three-dimensional structures of biopharmaceuticals, their heterogeneity and dependence on production in living cells makes them different from classical chemical drugs. Current analytical methods cannot characterize these complex molecules sufficiently to confirm structural equivalence with reference molecules. Verification of the similarity of biosimilars to innovator biopharmaceuticals remains a key challenge. Furthermore, a critical safety issue, the immunogenicity of biopharmaceuticals, has been highlighted in recent years, confirming a need for comprehensive immunogenicity testing prior to approval and extended post-marketing surveillance.

Biosimilars present a new set of challenges for regulatory authorities when compared with conventional generics. While the demonstration of a pharmacokinetic similarity is sufficient for conventional, small-molecule generic agents, a number of issues will make the approval of biosimilars more complicated. Documents recently published by the European Medicines Agency (EMEA) outlining requirements for the market approval of biosimilars provide much-needed guidance. The EMEA has approved a number of biosimilar products in a scientifically rigorous and balanced process. Outstanding issues include the interchangeability of biosimilars and innovator products, the possible need for unique naming to differentiate the various biopharmaceutical products, and more comprehensive labelling for biosimilars to include relevant clinical data.

Key Words: bioequivalence • biopharmaceuticals • biosimilars • epoetin alfa • pure red cell aplasia

Received for publication September 19, 2008. Accepted for publication October 21, 2008.


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