The major regulatory challenge for biosimilars is to prove that there are sufficiently similar to the innovator biologic such that the safety and efficacy are comparable. The similarity of two molecules is determined using the comparability exercise with four key parameters being addressed: safety, efficacy, quality and biological activity which are established. The choice of comparator (i.e. which innovator and where it is sourced) is a critical decision.

A previous EMA guidance on biosimilars (October 2005) was replaced with the updated guidance document in October 2014 to reflect a refinement in the agencies thinking. The biggest change between these two guidance documents is in the allowable comparators; previously it was essential that the comparator was sourced from within the European Union. With the new guidance it is possible to use ‘certain clinical studies and in vivo non-clinical studies’ with a comparator sourced from outside the EU. So although the approval of a biosimilars in the EU will not be possible solely on the basis of a biologic only approved in the US – there is certain leniency for the use of non-authorised product for supportive studies. The intention being to reduce the need for repetition of clinical studies and assist in the global development of biosimilars.

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