To gain an understanding of how stakeholders use or consult medicinal product information and to investigate their preferences for the content of biosimilar labels, a multi-stakeholder workshop was held in Brussels, Belgium.
As in the United States, there exist concerns in Europe about whether information on biosimilar product labeling is sufficient to meet the needs of end users—patients, pharmacists, and physicians—or whether changes to labeling are needed. To gain an understanding of how stakeholders use or consult medicinal product information and to investigate their preferences for the content of biosimilar labels, a multi-stakeholder workshop was held in Brussels, Belgium, on the topic of biosimilar labeling, and the results were recently published in the Generics and Biosimilars Initiative Journal.
The discussion focused on the perspectives of end users, and specifically on the Summary of Product Characteristics (SmPC), the Patient Leaflet (PL), and the immediate labeling on the outer product packaging. The workshop, sponsored by the European Biopharmaceutical Enterprises and the European Association for Bioindustries, was attended by 40 invited participants, including representatives of patients, physicians, pharmacist associations, academia, and industry. Representatives of the European Medicines Agency (EMA) attended the workshop by telephone as observers.
All stakeholders agreed on the need for better general understanding of the concept of biosimilarity, and also agreed that biosimilar labeling can be improved. Suggestions as to ways in which such labeling could be improved varied by stakeholder. Currently, once a biosimilar is approved for EU marketing, the EMA applies a same-label (generic) approach to biosimilar product labels, indicating that the information on the biosimilar’s labeling should be a copy of the approved labeling of the reference product (with the exception of the pharmaceutical particulars). The SmPC, which is not usually made available to patients, includes a statement declaring that the product is a biosimilar, but this is the only part of the labeling where this information can be found. Neither the PLs nor the immediate labels contain this information.
The stakeholders’ perspectives are summarized as follows: