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The challenge of follow-on biologics for treatment of multiple sclerosis

Reingold, S. C. and Steiner, J. P. and Polman, C. H. and Cohen, J. A. and Freedman, M. S. and Kappos, L. and Thompson, A. J. and Wolinsky, J. S.. (2009) The challenge of follow-on biologics for treatment of multiple sclerosis. Neurology, Vol. 73, H. 7. pp. 552-559.

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Official URL: http://edoc.unibas.ch/dok/A6007686

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Abstract

Intellectual property protections for biologic medicinals for multiple sclerosis (MS) are beginning to expire, opening the possibility of development, regulatory approval, and marketing of so-called follow-on biologics, biosimilars, or subsequent entry biologics that might be offered at lower price to consumers and third-party payers, as has been the case for generic drugs. Determining the comparability of a follow-on biologic to its innovator product is more difficult than for small-molecule drugs because of the greater complexity of biologics and the possibility that manufacturing differences can introduce differences in biologic activity and immunogenicity that could result in unpredictable differences in safety or efficacy. We provide a perspective on issues surrounding development, regulatory approval, and potential use of follow-on biologics, with an emphasis on disease-modifying agents for MS.
Faculties and Departments:03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Neurologie > Neuroimmunologie (Kappos)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Neurologie > Neuroimmunologie (Kappos)
UniBasel Contributors:Kappos, Ludwig
Item Type:Article, refereed
Article Subtype:Further Journal Contribution
Bibsysno:Link to catalogue
Publisher:Lancet Publications
ISSN:0028-3878
Note:Publication type according to Uni Basel Research Database: Journal item
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Last Modified:18 Jul 2014 09:10
Deposited On:18 Jul 2014 09:10

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