EBE position paper on Biosimilars Labelling

21 Aug 2013
EBE recommends that the label should be a combination of information on both the biosimilar and the reference product, we furthermore recommend that specific guidance for the labelling of biosimilars is developed on this basis taking into account the above suggestions and that the QRD template and guidance are similarly amended.  In addition, prescribing requirements should be included in order to improve traceability and enhance pharmacovigilance.  Details should be further developed in consultation with the relevant stakeholders.  We recommend against following approach A, namely the “generic approach”, for the labelling of biosimilars, which are not generics. We believe that the generation of specific guidance on the labelling of Biosimilars is of crucial importance in developing the understanding and acceptance of these products with all stakeholders.