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Clinical trials for etanercept biosimilars

Biosimilars/Research | Posted 22/05/2015 2 Post your comment

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

Nast and co-authors investigated what randomized controlled clinical trials for etanercept 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 one registered study of an etanercept biosimilar was being carried out in psoriasis patients. Three trials were also 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 etanercept biosimilars

For psoriasis, evidence is currently being sought for the etanercept biosimilar GP2015 in approximately 270 patients. Despite this, the authors pointed out that ‘the fact that, for instance, inflammatory bowel diseases respond to infliximab and adalimumab but not to etanercept, whereas etanercept, on the other hand, is effective in psoriasis and rheumatoid arthritis also clearly underlines the differences between the various disorders’.

The authors are therefore cautious about exchanging reference drugs with biosimilars and recommend that this ‘should only be done after careful consideration’.

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
Physicians, however, may not be well informed about the scientific concept underlying the principle of extrapolating* indications for biosimilars. It should be noted that infliximab cannot be used as an argument for lack of similarity of biosimilar etanercept to originator etanercept. The European Medicines Agency considers 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].

*Extrapolation involves extending and applying the data from clinical studies regarding one medical condition to another medical condition.

Readers interested to learn more about building user confidence in biosimilars in Europe are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe

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.

Clinical trials for adalimumab biosimilars

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References
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.
2. GaBI Online - Generics and Biosimilars Initiative. Extrapolation of indications in biosimilars: infliximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 2]. Available from: www.gabionline.net/Biosimilars/Research/Extrapolation-of-indications-in-biosimilars-infliximab

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Comments (2)

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Posted 03/06/2015 by Justyna K, GaBI Online Editorial Office

Response to ‘Apples and oranges’

Thank you for your valid and interesting comment. We have added an extra paragraph to the article explaining that these views may be flawed. We would also be very interested in publishing an article from you on your opinion about such views in the medical community. If interested please contact us at editorial@gabionline.net. Best Regards, Justyna

Posted 22/05/2015 by Martin

Apples and oranges

Cited:
the authors point out that ‘the fact that, for instance, inflammatory bowel diseases respond to infliximab and adalimumab but not to etanercept, whereas etanercept, on the other hand, is effective in psoriasis and rheumatoid arthritis also clearly underlines the differences between the various disorders’.

The authors are therefore cautious about exchanging reference drugs with biosimilars and recommend that this ‘should only be done after careful consideration’.

Comment:
This flaw in perception of idea of biosimilarity is being repeated over and over again. ECCO statement (Danese et al.) last year also noted that infliximab is not etanercept, so there should be no extrapolation of indications for INFLIXIMAB from RA/AS to CD and no interchangeability from reference INFLIXIMAB to biosimilar INFLIXIMAB. Where is the logic of using infliximab to etanercept (lack of) similarity argument to judge about infliximab to infliximab similarity or in this case ETA to ETA similarity?
For me, the idea of granting "biosimilarity", but without embracing extrapolation and interchangeability idea is troublesome. Putting quality/immunogenicity issues aside (as in EPOs case), the biosimilar is either truly similar on physicochemical level and then extrapolation of indications and interchangeability does not carry extra risks or the whole concept of biosimilarity is flawed.