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European Physicians Want More Detail on Biosimilar Labels


April 19, 2016.

European physicians would like more information on biosimilar labels, according to a survey by EuropaBio.

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 authorization 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.

Among the 210 physicians surveyed in seven EU countries, 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.

The survey was coordinated by EuropaBio with funding from six member companies (AbbVie, Amgen, MSD, Novartis, Novo Nordisk and Pfizer) and is published in Regulatory Toxicology and Pharmacology.

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