Search results for Summary of Product Characteristics (SmPC)

Biosimilar product labels in Europe: what information should they contain?

Abstract: In 2016, a multi-stakeholder workshop was held on the topic of ‘Biosimilar Labelling’. The discussions concerning labelling particulars are outlined in this meeting report. Submitted: 21 November 2016; Revised: 23 January 2017; Accepted: 24 January 2017; Published online first: 6 February 2017 Introduction Labels on medicinal products contain information for pharmacists, physicians and patients. […]

Read more →

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

Abstract: 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 […]

Read more →