The application for a marketing authorization for any biotechnological product must be submitted to the European Medicines Agency. It is therefore a centralized evaluation procedure. This procedure involves two independent teams of expert assessors from two member states to which, as appropriate, more experts may be added as determined by the regulatory agencies.
The regulatory authorities of the European Union (EMA) were pioneers in establishing a regulatory framework for biosimilars that has served as a reference for other reference agencies and therefore have acquired extensive experience in the evaluation of data from biosimilars. comparability exercises.
The results of this comparability exercise are contained in a registration dossier received by the evaluators. The evaluators proceed to the rigorous evaluation of the data by specialized teams at each stage of development (months to years of evaluation depending on the product).
If these data are assessed as satisfactory, the biosimilar will receive marketing authorization from the European Commission. Only with this authorization will the pharmaceutical company be able to market the drug in the European Union and the states of Iceland, Liechtenstein y Norway.