Clinical trials for infliximab biosimilars

Biosimilars/Research | Posted 29/05/2015 post-comment0 Post your comment

A systematic review into clinical trials for infliximab biosimilars was carried out as part of an investigation into biosimilars for the treatment of psoriasis by researchers from the Charité – Universitätsmedizin Berlin, Germany [1].

Clinical Trials 2 V13K29

Nast and co-authors investigated what randomized controlled clinical trials for infliximab 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 did not find any registered study of an infliximab biosimilar in psoriasis patients. However, they found two published studies and two ongoing studies 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 infliximab biosimilars

GW 2143 Table1

The infliximab biosimilars Remsima (Celltrion) and Inflectra (Hospira) have been authorized in the European Union since September 2013 [3].

The authors pointed out that this approval was based on ‘just one clinical trial (in rheumatoid arthritis) with clinical outcome as the primary endpoint and a second trial (in ankylosing spondylitis) with pharmacokinetics as the primary endpoint’ and clinical outcome only being provided as a secondary outcome. Therefore, direct data in psoriasis patients is missing.

The authors also believed that ‘confusion arises from the fact that there are two different names (Remsima and Inflectra) for the same product’. Celltrion and Hospira developed the product together as part of a collaboration agreement made back in 2009, which covered eight monoclonal antibody biosimilars. Both Remsima and Inflectra are made by Celltrion, with Hospira having the rights to market Inflectra in Europe, as well as in Australia, Canada, New Zealand and the US [4].

The authors raised the question of whether such diverse patient populations (psoriasis, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis) treated with the same biological may be compared at all. They pointed out that ‘in general, psoriasis patients have been exposed to previous treatment protocols (for example, UV therapy)’ and that ‘they also tend to exhibit different patient characteristics that may make them more susceptible to adverse drug reactions than other patient groups (for example, alcohol abuse, liver toxicity)’.

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
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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. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 29]. Available from: 
3.  GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 29]. Available from: 
4.  GaBI Online - Generics and Biosimilars Initiative. EMA approves first monoclonal antibody biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 29]. Available from:

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