Unravelling the Mystery Between Structure and Sustained Clinical Outcomes

Abstract

Targeted biologics have revolutionised the treatment and outlook of patients with inflammatory joint diseases. The combination of high-cost long-term therapy straining healthcare systems with impending expiry of key biologics patents has led to heightened interest in the development of biosimilars. The expanding landscape of biosimilars has triggered, in healthcare providers, the need to explore the option to non-medically switch stable patients from costly reference products to less expensive alternatives. Currently, there are many unknowns surrounding the effects of non-medical switching on patient outcomes and cost-effectiveness. Prof Edward Keystone opened the symposium by discussing the constantly evolving landscape of biologics, highlighting that their high cost is becoming an increasing challenge and has created the issue of non-medical switching. Dr Leigh Revers provided a background to the structural and functional relationships of biologic therapies, stressing the need for careful control of the manufacturing processes of these large and complex molecules. Prof Keystone presented the long-term data currently available for anti-tumour necrosis factor (anti-TNF) agents and examined how sustainability of response can be influenced by multiple factors. Prof Thomas Dörner concluded the symposium by stressing the importance of the prescribing doctor being in control of which biologics their patients receive to ensure effective pharmacovigilance. The challenge of non-medical switching was discussed along with the potential trial designs that could help to determine if biologics and biosimilars could be interchangeable.

Keywords

• EULAR
• European League Against Rheumatism