Terminology for biosimilars–a confusing minefield

Biosimilars are firmly established in the EU as copy biologicals with a clear and effective regulatory route for approval. Unfortunately, inconsistency in nomenclature for biosimilars has caused confusion. This problem of terminology has been the subject of a recent publication. The confusion is not just a potential concern for patient safety and efficacy, but also can lead to misconceptions in published reports. Several examples of this have occurred, some of which are discussed below. The definitions provided should be adopted for clarity in the future.