Recommendations to enhance transparency of biosimilar labels Posted 16/06/2017

On 6 June 2017, the European Association for Bioindustries (EuropaBio) announced that it had ‘developed recommendations for changes to the Summary of Product Characteristics (SmPC) of biosimilars that would result in an enhanced level of transparency in the label’.

The announcement comes in the wake of a survey the association carried out in 2015, in which it commissioned a study of physicians’ labelling preferences in Europe [1]. The results of the survey, according to EuropaBio, showed that doctors want more details in biosimilars labelling.

EuropaBio says that the ‘current EU approach to labelling does not reflect the specificities of biosimilars and that the SmPC of a biosimilar product should contain additional information to facilitate greater transparency for physicians and patients’.

The association has therefore concluded that the following ‘small yet meaningful changes to the biosimilar SmPC’ would improve the transparency of biosimilar labels:

  • Adding a statement with the definition of biosimilarity
  • Adding a direct link to the European public assessment report (EPAR) next to the biosimilarity statement
  • Moving the biosimilarity statement to the top of the SmPC

Mr Ronald Jager, EuropaBio Healthcare Biotech Director, said that EuropaBio is ‘convinced that a more transparent labelling approach would contribute to further facilitate the understanding and acceptance of biosimilars’.

EuropaBio has also called for distinguishable names for biosimilars, saying that this would also ‘enhance traceability, providing transparent information in biosimilar product labels, facilitating physician and patient understanding as well as respecting physicians’ prescribing authority’ [2].

Related article
FDA issues draft guidance on biosimilars labelling

1. GaBI Online - Generics and Biosimilars Initiative. Doctors want more details in biosimilars labelling []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. EuropaBio calls for distinguishable names for biosimilars despite potential of big savings []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from:

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Source: EuropaBio

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