European Stakeholders on Biosimilar Labeling: More Education, Clarity, and Transparency Needed

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:

• Pharmacists. Pharmacists’ representatives said it is very important to have a clear and understandable naming system for biologics, ideally an internationally agreed-upon system, to assist in global traceability and pharmacovigilance. Hospital pharmacists in particular work regularly with the SmPCs and frequently consult the European public assessment report (EPAR). They believe the SmPC should not become more extensive than it is and should not include more data, but rather should provide clear cross-references to specific sections of the EPAR. These cross-references could then be used to explain any instances of extrapolated data or any specific pharmacovigilance requirements.
• Physicians. Physicians’ representatives advocated for more transparency in biosimilar labeling and said that the information should be more reliable, clear, and easily accessible. They said that the most important consideration for prescribers of biosimilars is the assurance that the product will be as effective and safe as its reference product, and noted that safety and efficacy must be considered if biosimilar prescribing is to increase. Furthermore, updated information on pharmacokinetics, immunogenicity, and switching must always be available to physicians. Physicians also believe that a statement declaring which indications were extrapolated and which underwent clinical studies could be added to the labels of biosimilars to provide more clarity. Like pharmacists, physicians did not want to see an increase in length or complexity of the SmPC.
• Patients. Representatives of patient organizations stressed that patients have the right to know which product is being administered and whether they are receiving a biosimilar or originator biologic. Patient leaflets should include explanations of what a biosimilar is, and labeling should clarify that a listed adverse effect relates to the originator biological; reporting of unlisted adverse effects should be encouraged for both biosimilars and reference drugs. Patient representatives also said that patients should be made aware of different versions of the same originator product and different unique biosimilars. Clear, transparent, and real-time information designed for patients to understand should be made available, they said.