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.

Related articles
Clinical trials of biosimilars for psoriasis treatment

Clinical trials for etanercept biosimilars

Clinical trials for infliximab biosimilars

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.

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2015 Pro Pharma Communications International. All Rights Reserved.