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Biosimilars - specific features of the approval process in the European Union by Jan Strojil is a scholarly article available to read on EtoBox.

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With several high-profile biologics nearing the expiration of their patents, the focus is now on follow-up biologic products, also called biosimilars. This paper reviews the current European Union regulation of the biosimilar approval pathway, particularly in contrast to the traditional generic drug approval process. Using the example of biosimilar infliximab, the paper describes the main specific features of the development and characterization of biologics, including a current discussion on nomenclature and patient, physician information, and automatic substitution.

Author

Jan Strojil

Published

2014