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

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Rita Oliveira - Corresponding Author
Teresa Aires

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.

Keywords: Biological Products; Biosimilar Pharmaceuticals; Drug Approval; Europe; Product Surveillance Postmarketing; Therapeutic Equivalency

Article Details

1.
Oliveira R, Aires T. Biosimilars: Old Issues, New Challenges: Biossimilares: Velhas Questões, Novos Desafios. Gaz Med [Internet]. 2018 Feb. 21 [cited 2021 Dec. 3];3(3). Available from: https://www.gazetamedica.pt/index.php/gazeta/article/view/102
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