EBE-EFPIA POSITION PAPER

1. Introduction

The introduction of similar biological medicinal products (biosimilars) into clinical practice resents new challenges that are not ordinarily presented by small-molecule generic medicines.
This is because a biosimilar can only be proven to be similar and not identical to its reference product. This fundamental difference has been acknowledged throughout the development of the pharmaceutical legislation for biosimilars, which takes the approach that biosimilars are not generics and must therefore be treated differently.
The summary of product characteristics (SmPC) and package leaflet, collectively “the labelling” are important documents for all medicinal products. The SmPC sets out the agreed regulatory position on the medicinal product as determined during the course of the regulatory assessment process and forms the basis of information for healthcare professionals and patients on how to use the medicinal product safely and effectively 1.