Klin Farmakol Farm. 2014;28(1):14-18
Biosimilars - specific features of the approval process in the European Union
- Ústav farmakologie, Lékařská fakulta, Univerzita Palackého v Olomouci
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.
Keywords: biologics, biosimilars, infliximab, regulation, drug approval
Published: March 1, 2014 Show citation
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