Similar biological medicinal products: lessons learned and challenges ahead

Abstract

The first similar biological medicinal products (or biosimilars) were approved in the European Union (EU) in 2006 in accordance to a regulatory framework published by the European Commission in 2003 and 2004. The term ‘similar biological’ or biosimilar was preferred instead of the term ‘biogeneric’ as, in contrast to small molecules in chemical drugs, due to the size and complexity of biological products, additional safety and efficacy studies would be needed to establish comparability to a reference product. Several product-specific guidelines have already been developed by the European Medicines Agency describing the requirements to establish comparability on quality, safety and efficacy to the reference product and some others are currently under development. Even though the harmonized European regulatory framework for biosimilars there appear to be marked differences among the EU countries in the perception of the value and use of biosimilars. Several factors have been considered as challenges to their wide use such as concerns about their safety and efficacy, pharmacovigilance, interchangeability and substitution, market competition, and extrapolation of indications. A proper knowledge of these issues is required to ensure an appropriate place on the market for these products.