Substitution and Interchangeability

Abstract

The copy of an original medicine put on the market always leads to the question of substitution and interchangeability. Where the European registration of biosimilars is centralised as for reference products, the issue of substitution remains the specific field of the European Community Member States. In this chapter is described the French regulatory position—that does not allow the substitution of a reference biological product by a biosimilar, differing from what is possible for generics, for which the pharmacist has the right of substitution short of prescriber’s opposition. In parallel, the conditions of biosimilars’ interchangeability compared to reference products’. Interchangeability is the result of a medical prescription processed by the various players of medical treatment and according to predefined recommendations.