Biosimilars versus ‘biobetters’—a regulator’s perspective

Author(s): René Anour, DVM

Abstract: The attractiveness of the biosimilar regulatory pathway is threatened by so-called biobetters. This paper provides definitions and an overview of recent developments. Submitted: 27 October 2014; Revised: 7 November 2014; Accepted: 12 November 2014; Published online first: 25 November 2014 Concerning the biosimilar landscape, the European Medicines Agency (EMA) was among the first institutions […]

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