Biosimilars: Old Issues, New Challenges Biossimilares: Velhas Questões, Novos Desafios

Abstract

According to the European Medicines Agency, EMA, a biosimilar is one that is obtained by biotechnology containing a version of the active substance of the original biological medicine previously authorized in the European Economic Area.
The similarity between the reference and biosimilar drug in terms of quality, biological activity, safety and efficacy must be established in accordance to comparability criteria.