Biologicals and Biosimilars

Abstract

What safety relevant standards are established for biotechnology-derived biosimilar products in both the European Union (EU) and the USA? And, is there potential to improve the current safety standards? The applicable scientific guidance documents for Biosimilars issued by the European Medinces Agency (EMA) and the US Food and Drug Administration (FDA) were analyzed and compared with respect to their safety requirements. The guidance documents were found to have very similar grade of regulation and scientific content. The identified differences are related to the overall regulatory requirements, the clinical safety requirements and quality considerations. Within these sectors the primary areas for improvement in the both regions (EU and USA) were identified. Although the regulatory approach and the scientific contents of the analyzed biosimilars guidance documents are very similar the identified differences could influence the safety of Biosimilars.