Recommendations to enhance biosimilar label transparency in Europe

9 June 2017

Biotech industry trade group EuropaBio has 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.

EuropaBio members believe that the current European Union 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.

Based on interactions that EuropaBio had with various stakeholders including physicians and patients over recent years, it has concluded that label transparency would be enhanced by implementing the following small yet meaningful changes to the biosimilar SmPC:

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