Abstract
Biosimilar medicines are a new category of medicinal products that substantially differ from generic preparations through the necessary submission of conclusive evidence of their therapeutic efficacy and therefore it is not sufficient to merely state their biological equivalence. Apart from the proven efficacy, also their safety is evaluated of course, with an emphasis on immunogenicity regarding biological nature of these substances.
As a result, requirements for registration are much stricter. With regard to the current boom of the preparations labelled in a simplified way as biological or specifically targeted drugs, we can certainly expect a growing number of newly registered medicinal products in this category in the near future.
Last year, a biosimilar insulin analogue of glargine was approved for administration at the level of the European Medicines Agency (EMA) in accordance with the aforementioned procedures; its efficacy and safety profile have been found within the registration studies practically identical, or non-inferior, to the original insulin analogue.
