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Data included in the prescribing information and EMA assessment reports for biosimilars

Data for prescribing: summary of product characteristics (SmPC)

Data on biosimilarity: published in the assessment report

The EU SmPC includes information and recommendations to enable healthcare professionals to prescribe the medicine and to give advice to patients on its use. Section 5.1 (pharmacodynamic properties) of the SmPC will identify a medicine as a biosimilar with the following wording: [Brand name] is a biosimilar medicinal product. Detailed information is available on the website of the European Medicines Agency http://www.ema. europa.eu. In the EU, the SmPC of a biosimilar is aligned with that of the reference medicine. The biosimilar’s SmPC mentions the name of the active substance (i.e. INN) and not the tradename of the reference medicine. Details of the studies with the biosimilar as well as the tradename of the reference medicine can be found in EMA’s assessment report, available on EMA’s website. A biosimilar can be approved for some or all of the authorised indications of the reference medicine, as a company may choose not to apply for all the reference medicine’s indications. Healthcare professionals should check that the biosimilar is authorised for the intended indication. When a company does not apply for all the indications of the reference medicine, efficacy data on the additional indications are not included in the biosimilar’s SmPC, however safety data are reflected.

For each medicine approved through EMA, including biosimilars, EMA publishes a group of documents known as the european public assessment report (‘EPAR’). In addition to the EU product information (SmPC, package labelling and package leaflet), the EPAR documents contain assessment reports on the scientific evaluation of the medicine at the time of approval and when major changes are introduced (e.g. when a new indication is added). Details of how each biosimilar was developed and on the comparability studies to demonstrate biosimilarity are given in their assessment reports. These include information on analytical and functional comparability, pharmacokinetics, clinical comparability and immunogenicity. Where applicable, the assessment report also includes the scientific rationale for extrapolation of data. Over 50 biosimilars have been approved through EMA for use in the EU as at April 2017. Their assessment reports can be accessed on EMA’s website, on the landing page of each medicine, under the tab ‘assessment history’.

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