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Biosimilar epoetins

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Erythropoietins, Erythropoietic Factors, and Erythropoiesis

Part of the book series: Milestones in Drug Therapy ((MDT))

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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 [2–9], while in the United States the regulatory pathway is still being developed[10].

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Author information

Authors and Affiliations

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

    Huub Schellekens

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  1. Huub Schellekens
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Editors and Affiliations

  1. Amgen Inc., One Amgen Center Drive, Mailstop 29-1-A, Thousand Oaks, CA, 91320, USA

    Steven G. Elliott

  2. MA Foote Associates, Westlake Village, CA, 91362, USA

    Mary Ann Foote

  3. Amgen Inc., One Amgen Center Drive, Mailstop 15-2-A, Thousand Oaks, CA, 91320, USA

    Graham Molineux

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© 2009 Birkhäuser Verlag/Switzerland

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Schellekens, H. (2009). Biosimilar epoetins. In: Elliott, S.G., Foote, M.A., Molineux, G. (eds) Erythropoietins, Erythropoietic Factors, and Erythropoiesis. Milestones in Drug Therapy. Birkhäuser Basel. https://doi.org/10.1007/978-3-7643-8698-6_7

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