EU physicians prefer greater detail in the labeling of biosimilars

Physicians in Europe would like to have more information in the biosimilar label than is currently available for these biological copy drugs, new research shows.

This was one of the main outcomes of a survey among more than 200 physicians in seven countries which has been published in the scientific journal Regulatory Toxicology and Pharmacology. The survey was initiated and supported by trade group 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 European Union, 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.