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Biosimilar epoetins

  • Huub Schellekens
Part of the Milestones in Drug Therapy book series (MDT)

Abstract

Recombinant DNA technology and hybridoma techniques enabled the development of therapeutic proteins such as the interferons (IFN), erythropoietin (EPO), insulin, growth hormones, cytokines, and monoclonal antibodies [1]. These proteins have revolutionised the treatment of many diseases, including, cancer, hepatitis, and multiple sclerosis. The patents of the first generation of biopharmaceuticals have expired or are about to expire, which enables marketing of noninnovator versions of these products, named ‘biosimilars’ in the European Union (EU), and ‘follow-on protein products’ in the USA. The EU has established a legal and regulatory framework for acquiring a marketing authorisation for biosimilars to market [2, 3, 4, 5, 6, 7, 8, 9], while in the United States the regulatory pathway is still being developed[10].

Keywords

European Union European Medicine Agency Therapeutic Protein Reference Product Marketing Authorisation 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Birkhäuser Verlag/Switzerland 2009

Authors and Affiliations

  • Huub Schellekens
    • 1
  1. 1.Departments of Pharmaceutical Sciences and Innovation StudiesUtrecht UniversityUtrechtThe Netherlands

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