The European Medicines Agency (EMA) organised a workshop to discuss with regulators and stakeholders the three draft revised guidelines on biosimilars, including comments received so far during the public consultation. Presentations and discussions during the workshop have been focused on the following topics: the choice of the reference product, the concept of quality target-product profile, the stepwise approach to non-clinical programme and biosimilar-specific clinical models and endpoints. More information is available on the EMA website.