Press release

Results from the first ever European biosimilars labelling survey

Peer-review survey shows physicians would like to have more information in the biosimilar label than is currently available.

Brussels, 19 April 2016 – Physicians would like to have more information in the biosimilar label than is currently available. This was one of the main outcomes of a survey among more than 200 physicians in 7 countries which has been published in the scientific journal Regulatory Toxicology and Pharmacology. The survey was initiated and supported by EuropaBio with the aim to assess information needs of physicians.

The label of a medicinal product, also called Summaries of Product Characteristics (SmPC) is an important tool for prescribing physicians. In the EU, labels of biosimilars and their reference products are in many instances almost identical (following the approach for generic medicines) despite different data requirements for the authorisation of biosimilars and generics. The survey aimed to explore physicians’ preferences regarding the type and the amount of information on biosimilar labels as well as their use of information sources when prescribing biologics, including biosimilars.

More than 80% preferred labels with additional biosimilar information

Among the  physicians surveyed, 91% stated that they use the label frequently or occasionally as a source of information and 87% deemed helpful or very helpful to include a clear statement on the origin of the biosimilar’s data on the label. When comparing a standard label of an authorised biosimilar with a label containing additional relevant information (e.g. pharmacology, adverse events, dosage schedule and method of administration sections of the label), the vast majority of physicians (83%) preferred the one with additional information about what data had been generated with which product.

Survey provides first time empirical evidence of physicians’ preferences

“With this peer-reviewed survey EuropaBio has provided empirical evidence for an informed discussion about labelling. We look forward to discussing the findings and what steps have to be taken with stakeholders”, explains Nathalie Moll, EuropaBio Secretary General.

This survey of 210 physicians was conducted between April to May 2015 in seven EU countries (France, Germany, Italy, Poland, Spain, Sweden and the United Kingdom) via an online anonymised questionnaire. Various physicians were sampled, including dermatologists, endocrinologists, gastroenterologists, haematologists, nephrologists, oncologists and rheumatologists. The vast majority of physicians (84%) had more than 10 years of practice.  90% had already prescribed a biologic and 59% a biosimilar.

The survey was coordinated by EuropaBio with funding from six member companies (AbbVie, Amgen, MSD, Novartis, Novo Nordisk and Pfizer) and has been published in the scientific journal Regulatory Toxicology and Pharmacology following a peer-review process.

Workshop on biosimilar labelling

The European Biopharmaceutical Enterprises (EBE) and the European Association for Bioindustries (EuropaBio) organised a multi-stakeholder Biosimilar Labelling workshop in Brussels on 2 February 2016.

The main aim of the workshop was to gain an understanding of how stakeholders use or consult medicinal product information and to investigate their preferences regarding the content of biosimilar labels. The focus was on perspectives of end-users of product labels, namely patients, physicians and pharmacists. During the workshop, reference was made to ‘the label’ without further specification. From the context of the discussion, this may mean the label on the outer packaging of the product, the Summary of product Characteristics (SmPC), the Patient Leaflet (PL) or all elements of the product literature.

The workshop report provides a summary of the outcomes of that discussion.