MEETING ABSTRACT Open Access Current status and considerations on biosimilar

2010[1], twenty two Countries and regions including EU and FDA have established their guidelines or guideline drafts on evaluation of biosimilar. In terms of the technical features, WHO guidelines are consistent with that of EU[2-4], head-to-head comparison exercise between SBP and reference biotherapeutic pro-duct (RBP) are required. In the prerequisite of quality similarity, the unnecessary or repeated non-clinical and/or clinical data might be reduced. Furthermore, extrapolation to other indications of the RBP may be possible. As for the FDA draft, requirements of interchangeability and substi-tution of SBP with RBP were introduced [5,6]. Guidelines of other developing countries generally used the WHO guidelines and the FDA guidance draft as blueprints to set up the technical requirements. These regulations an