Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe
The European Medicines Agency (EMA) has led the development of biosimilar regulatory pathways globally, tailoring their approach to meet the specific and scientifically determined needs of biosimilar development. However, the information-driven stepwise approach encouraged by this pathway leading to approval of biosimilar products is only reflected in a single section of the product labelling for healthcare professionals and patients, which so far has followed a generic approach in Europe.This paper reviews the need for sufficiently detailed and transparent labelling and product information (PI) regarding biosimilars to enable informed decision making by physicians and patients and therefore ensure appropriate safe and effective use of the medicine. The authors, representing the European Biopharmaceutical Enterprises (EBE), argue that it is necessary to ensure that the evidentiary basis and terms of approval for each biosimilar and its reference product are clear, and so they set out a proposal for transparency concerning evidence generated for these respective products. Approaches to labelling of biosimilars will be examined to highlight potential ways forward in ensuring more informed clinical use and to generate trust in these important medicines. A consideration of these various aspects will illustrate the value to have detailed specific guidance on biosimilar labelling, which could be developed based on open dialogue with key stakeholders.
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