Safety considerations of biosimilarscurrent regulatory pathways for biosimilar drugs in Australia (and internationally) which demand clinical data showing that the biosimilar is equally as safe and efficacious as the originator biologic drug.* Bioequivalence is shown when, after administration, two products produce such similar plasma concentrations of the active ingredient that their clinical effects can be expected to be essentially the same.
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McKinnon et al. (2016) studied this question.
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