Clinical trials for adalimumab biosimilars

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Clinical trials for adalimumab biosimilars

Biosimilares/Investigación | Posted 15/05/2015 0 Post your comment

As part of their investigation into biosimilars for the treatment of psoriasis, researchers from the Charité – Universitätsmedizin Berlin, Germany, carried out a systematic review into clinical trials for adalimumab biosimilars [1].

Nast and co-authors investigated what randomized controlled clinical trials for adalimumab biosimilars compared to the reference biological had been or were currently being carried out and in what indications.

The authors systematically reviewed published trials on the efficacy and safety of biosimilars and registers for planned and ongoing trials with biosimilars.

They found two registered studies of adalimumab biosimilars were being carried out in psoriasis patients. One more trial was being carried out in rheumatoid arthritis patients. No trials were identified as being carried out in ankylosing spondylitis, ulcerative colitis, Crohn’s disease or psoriatic arthritis, see Table 1.

Table 1: Clinical trials of adalimumab biosimilars

For psoriasis, evidence is currently being sought for the adalimumab biosimilars ABP 501 and GP2017 in almost 400 patients. Despite this, the authors believe that ‘the present situation in terms of registered trials is unsatisfactory and will leave clinicians with a high degree of uncertainty with respect to their treatment decisions’.

Conflict of interest
The authors of the research paper [1] 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 safety assessments for biosimilars in Europe are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Safety assessment of biosimilars in Europe: a regulatory perspective

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal platform – please send us your submission here.

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Reference
1. 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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