On 2 February 2016, EuropaBio, the European Association for Bio Industries, and EBE, the European Biopharmaceutical Enterprises, jointly facilitated a multi-stakeholder workshop in Brussels on the labelling of biosimilar medicinal products. 40 people participated in the meeting, including representatives of EU and national associations of patients, physicians and pharmacists. Three representatives from the European Medicines Agency (EMA) attended the meeting as observers. 

Update 3 May 2016: Meeting summary available for download

As of today, there is limited information available as to whether physicians, patients and pharmacists consider the information currently provided in the labels of biosimilar medicinal products sufficient or whether they see a need for additional information. It was the objective of the workshop to provide a forum for an open and interactive discussion about the way stakeholders consult medicinal product information and about their preferences for the content of biosimilar labels, thereby focusing on the end-users of the product labels (patients, physicians, pharmacists).

The workshop started with a factual overview on the biosimilarity concept and product labeling (with an emphasis on biosimilar labeling) and included an exchange of views among all stakeholder groups on the topic of biosimilar labelling. Patient, pharmacist and physician representatives shared insights and comments about the way they consult medicinal product information and about their preferences for the content of a biosimilar SmPC and/or PIL.  

The summary meeting report from the workshop is now available here (Update 3 May 2016).

Background

A general introduction to medicinal product labelling is available on the EMA website here. In 2012, the article “Setting the stage for biosimilar monoclonal antibodies” by C. Schneider et al. (EMA BMWP members) highlighted three scenarios for the content of biosimilar labels. These ranged from having identical labels for biosimilars and reference products (the current approach in the EU) to having a biosimilar label that only includes information generated (or confirmed) with the biosimilar. The third scenario suggested a “combined” label, containing information from the reference and the biosimilar product. This article was presented at the beginning of the EuropaBio-EBE workshop.

Further References on EuropaBio and EBE positions on biosimilar labelling:

Please note that, at the meeting, initial results of an EU physician survey on biosimilar labeling have been presented. Outcomes of the survey are due for publication.

22 February 2016 in Highlights