Unravelling the Mystery Between Structure and Sustained Clinical Outcomes - European Medical Journal

Unravelling the Mystery Between Structure and Sustained Clinical Outcomes

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Edward Keystone1
Edward Keystone,1 Leigh Revers,2 Thomas Dörner3

Thomas Dörner has received research grants from Merck, UCB, Roche/Chugai and Janssen, and honoraria for consulting or lecture fees from Roche, Eli Lilly, Hospira, Sanofi, Pfizer, Abbvie, Biogen and Samsung Bioepis (each below 10.000 USD). Edward Keystone has received Funding for Research from: Abbott Laboratories, Amgen Inc., AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Janssen Inc, Lilly Pharmaceuticals, Novartis Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, UCB, has a consulting agreement/advisory board membership with Abbott Laboratories, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Crescendo Bioscience, F. Hoffmann-La Roche Inc, Genentech Inc, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, and UCB, and has received speaker honoraria from Abbott Laboratories, Astrazeneca LP, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen Inc., Pfizer Pharmaceuticals, UCB, Amgen. Leigh Revers has engaged in paid and unpaid academic activities sponsored by AbbVie, Amgen, Boehringer Ingelheim, Hoffman-La Roche, Hospira, Ikaria, Janssen, and UCB.


Writing assistance was provided by Dr Clare Driscoll of ApotheCom.


The symposium was jointly organised and funded by AbbVie. All authors received honoraria for preparation and delivery of their presentations. The publication of this article was funded by AbbVie. The paper is an interpretation of the views of the speakers, but is not written by them. The views and opinions expressed are those of the authors and not necessarily of AbbVie.

EMJ Rheumatol. ;3[1]:48-56. DOI/10.33590/emjrheumatol/10314424. https://doi.org/10.33590/emjrheumatol/10314424.
EULAR, European League Against Rheumatism

Each article is made available under the terms of the Creative Commons Attribution-Non Commercial 4.0 License.

Meeting Summary

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.

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