EuropaBio members believe 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.
Based on interactions that EuropaBio had with various stakeholders, including physicians and patients over recent years, the conclusion was that label transparency would be enhanced by implementing the following small yet meaningful changes to the biosimilar SmPC:
- Adding a statement with the definition of biosimilarity
- Adding a direct link to the EPAR next to the biosimilarity statement
- Moving the biosimilarity statement to the top of the SmPC
A full position paper is available at europabio.org/healthcare-biotech and provides a basis for future exchanges and next steps in this area with regulators and other stakeholders.