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The requirements and procedures for the marketing authorization for medicinal products for human use in Europe Union (EU) are primarily laid down in Directive 2001/83/EC, as amended. This Directive provides distinct legal frameworks for innovat or products, small molecule generic products and biosimilar products, dictating the amount of quality, pre-clinical and clinical data required to support approval and marketing. To the latter point, small molecule generic products whose formulation or manufacturing method have not been modifi ed in any way that may impact the bioavailability [3] do not require any preclinical or clinical trial data of their own as bioequivalence with a reference product (innovator) can be established through in vitro testing alone. For biosimilar products, in contrast, such a formulaic approach cannot be used. The amount of data to be generated is determined in a stepwise approach, directly comparing the biosimilar with the reference product and the outcome informing the next step. This may result in the need for more or less extensive comparative clinical data. Indeed, the European Medicines Agency (EMA) draft revised guideline, ‘Guideline on Similar Biological Medicinal Products’ states that ‘standard generic approach (demonstration of bioequivalence with a reference medicinal product by appropriate bioavailability studies) which is applicable to most chemically-derived medicinal products is in principle not appropriate to biological/ biotechnology-derived products due to their complexity’ [4]. The legal framework for biosimilars enabled EMA to pioneer the regulatory review of biosimilars according to a new scientifi c approach [5]. However, legal and scientifi c distinction has not been consistently refl ected in the product labelling, with there being differences in the level of detail provided.

Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe