Reproduced biological preparations are called non-generic, but bio-analogs. The name itself contains a key meaning: these drugs are not identical, but only are similar original. This is due to the structural complexity of biological preparations (as a rule, these are huge protein molecules) and the features of the technological process. So, if generics are most often produced in a laboratory using chemical synthesis, then the production of biological products is based on genetic engineering and cellular technologies.
In addition, regulatory authorities place special demands on bioanalogy studies: they are required to undergo pharmacokinetics and pharmacodynamics studies, as well as at least one study of efficacy and safety in comparison with the original drug. While generics are most often released to the market after studies of bioequivalence alone.
Nevertheless, despite all the difficulties, more and more bio-analogs are in production, because this is an absolute benefit for all health care participants.
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