The European Medicines Agency (EMA) has published a concept paper outlining a number of clinical and non-clinical issues that need revision in its current “Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance.” Comments are requested by December 31, 2011.

Among other matters, EMA is re-evaluating “the selection of relevant species for non-clinical studies, need for clinical equivalence studies and other issues [in] the design of the pivotal clinical studies, role of biomarkers, amount of immunogenicity data needed, and the possibility to extrapolate to other indications.” According to the concept paper, EMA has prioritized reducing the number animal experiments required. The current guideline took effect in June 2006; experience with that version and rapid advances in the field have apparently led to its re-evaluation. EMA anticipates publishing a draft revised guideline in early 2012