Tumour necrosis factor-alpha (TNF-alpha) is a cytokine, or protein, that prompts the body to create inflammation. In psoriasis and psoriatic arthritis, there is excess production of TNF-alpha in the skin or joints. Therefore, drugs that block TNF-alpha, such as Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab) and Stelara (ustekinumab), can be used to treat psoriasis and psoriatic arthritis.
Biosimilars for the treatment of psoriasis are currently being developed. For approval, the European Medicines Agency (EMA) considers indirect evidence, i.e. extrapolation*, from other indications, for example, rheumatoid arthritis, as sufficient.
EMA states in its overarching guideline on similar biological medicinal products that ‘if biosimilarity has been demonstrated in one indication, extrapolation to other indications of the reference product could be acceptable with appropriate scientific justification’ [1]. According to members of EMA’s Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP) for biosimilars, extrapolation of efficacy and safety data from one indication to another may be considered if biosimilarity to the reference product has been shown by a comprehensive comparability programme. If the relevant mechanism of action of the active substance and the target receptor(s) involved in the tested and in the extrapolated indication(s) are the same, extrapolation is usually possible [2].
Researchers from the Charité – Universitätsmediz in Berlin, Germany, therefore investigated what clinical trials of biosimilars for adalimumab, etanercept, infliximab and ustekinumab compared to the reference biological were currently being carried out and in what indications [3].
Their research found that there were no trials on biosimilars for ustekinumab. For infliximab biosimilars, they found data on patients with ankylosing spondylitis and rheumatoid arthritis, indicating no clinically relevant differences regarding efficacy and safety. While two registered studies of adalimumab biosimilars and one study of an etanercept biosimilar were being carried out in psoriasis patients. Ongoing studies on adalimumab, etanercept and infliximab biosimilars in rheumatoid arthritis patients were also identified.
In the following series of three articles, the clinical trials identified by Nast and co-authors for adalimumab, etanercept and infliximab biosimilars are presented.
*Extrapolation involves extending and applying the data from clinical studies regarding one medical condition to another medical condition.
Conflict of interest
The authors of the research paper [3] declared that Nast had received honoraria for CME certified educational talks that received direct or indirect sponsoring from Abbott (now AbbVie). Rosumeck and Seidenschnur declared no conflicts of interest.
Editor’s comment
Readers interested to learn more about developments in biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Top developments in biosimilars during 2014
Readers interested in contributing a review or research paper to GaBI Journal – an independent, peer reviewed academic journal platform – please send us your submission here.
Related articles
Clinical trials for infliximab biosimilars
Clinical trials for adalimumab biosimilars
Clinical trials for etanercept biosimilars
References
1. GaBI Online - Generics and Biosimilars Initiative. EMA issues revised version of overarching biosimilars guideline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 8]. Available from: www.gabionline.net/Guidelines/EMA-issues-revised-version-of-overarching-biosimilars-guideline
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars: when indications can be extrapolated [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 8]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilars-when-indications-can-be-extrapolated
3. Nast A, Rosumeck S, Seidenschnur K. Biosimilars: a systematic review of published and ongoing clinical trials of antipsoriatics in chronic inflammatory diseases. J Dtsch Dermatol Ges. 2015;13(4):294-300.
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