Regulatory approval of biosimilars requires a demonstration of comparable clinical efficacy and safety with the reference biologic and the key steps in the process are described here by Professor Irene Krämer.

Professor Alain Astier discusses the complexities surrounding the manufacturing processes of a biosimilar, and the characteristic variability and strict quality control measures involved in their production.

Dr Tiene Bauters discusses how the interpretation of interchangeability and rules around switching of biosimilars differ between healthcare systems across the globe and the resulting implications on access to care.

Hospital Pharmacy Europe had the pleasure of hearing from Elena Nikiphorou (Consultant Rheumatologist and Honorary Senior Lecturer at Kings College London, UK) on the recent EULAR guidelines and the importance of self-management strategies in supporting the patient with inflammatory arthritis