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2001/83/EC [2] and subsequently extended in a growing number of guidelines and authorized products on the market (published on the European Medicines Agency [EMA] website) [3]. Generics are usually approved on the basis of demonstration of bioequivalence with the originator reference product, but a more comprehensive development programme is needed for biosimilars. This involves extensive comparability studies at the level of quality characteristics, biological activity and functional characterization. Non-clinical and clinical data are also needed, normally not only including a comparison of pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, but also requiring the demonstration of equivalence in effi cacy and comparable safety between the biosimilar and the biological reference product. Details of the studies and data required for marketing authorization are addressed in the EMA guidelines on quality issues and on non-clinical and clinical issues relating to biosimilars, both of which are currently under revision [4, 5], as well as in further product specifi c biosimilar guidelines [3]. In specifi c cases, where there is a reliable and validated surrogate PD parameter for demonstration of effi cacy, approval can be accepted on the basis of clinical data limited to similarity in PK and PD as well as safety.

Biosimilar monoclonal antibodies—challenges and opportunities in Europe