The global prevalence of diabetes in adults aged 20–79 years was estimated to be 8.8% in 2017 and predicted to rise to 9,9% in 2045. The lack of access to affordable insulin remains a key impediment to successful treatment and results in the development of acute/chronic complications and premature deaths. Biosimilars provide an alternative to existing biological medicines that have lost patent protection.
In September 2014 the European Medicines Agency (EMA) granted the first market authorisation valid throughout the European Union for a biosimilar insulin, and the latest at the end of May 2017. Reflecting on the importance of the subject for the whole European Diabetes Community and given the potential opportunities and challenges linked to the introduction of biosimilar insulins, the International Diabetes Federation European Region (IDF Europe) presents a position paper on biosimilars in the treatment of people with diabetes which summarises current regulations and provides recommendations to all diabetes stakeholders: healthcare professionals, people with diabetes, pharmaceutical companies, national authorities and health related services, IDF Europe member associations.