In late October, EMA released a final update to its 2005 Similar Biological Medicinal Products guideline. A draft update was released in May 2013 to clarify how biosimilarity is defined regarding safety, efficacy, quality, and biological activity. Changes from the draft to the final include clarification on the need for similarity to the reference product and for the justification of deviations from that, the possibility of extrapolation to other indications of the reference product, and that clinical data cannot be used to justify differences in quality attributes.
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