Table 3.

Safety risk management requirements for biosimilars in Europe

Module	Details	Required for biosimilars
Module S1	Epidemiology of the indication(s) and target population(s)	No
Module SII	Non-clinical part of the safety specification	Yes
Module SIII	Clinical trial exposure	Yes
Module SIV	Populations not studied in clinical trials	Yes
Module SV	Post-authorization experience	Yes
Module SVI	Additional EU requirements for the safety specification	Yes
Module SVII	Identified and potential risks	Yes
Module SVIII	Summary of the safety concerns	Yes

Adapted from EU’s new pharmacovigilance legislation: considerations for biosimilars. Drug Saf 2014;37:9–18. Calvo B, Zuñiga L, © 2013 [51]. With permission of Springer. With additional information from [60]. EU: European Union.