Switching to biosimilars safe and effective in IBD patients

Biosimilars/Research | Posted 16/07/2021 post-comment0 Post your comment

Multiple adalimumab biosimilars are now approved for use in inflammatory bowel disease (IBD). In fact, to date, 29 June 2021, there are 10 adalimumab biosimilars approved in Europe [1]. However, despite their approval, effectiveness and safety data in IBD remains scarce, according to authors from the UK and The Netherlands [2].


Lauranne Derikx and colleagues carried out an observational cohort study in a tertiary IBD referral centre. All IBD patients treated with the originator biological Humira (adalimumab) underwent an elective switch to the biosimilar Imraldi (SB5). Imraldi was approved in Europe in August 2021 [1]. Hadlima (SB5) was approved in the US in July 2019 [3]. However, due to litigation and deals made by originator maker AbbVie [3], Hadlima will only be available in the US in June 2023 [4].

Adults with IBD, who were taking adalimumab as maintenance therapy as of 1 February 2019 were identified from a biological prescription database. A total of 481 patients were treated with Imraldi, 256 in the SB5-switch cohort and 225 in the SB5-start cohort. The median follow-up for patients was 13.7 months [8.6-15.2] and 8.3 months [4.2-12.8] in the SB5-switch and SB5-start cohorts, respectively, and 70.8% of the SB5-switch cohort remained on SB5 beyond one year. Of the 256 patients in the SB5-switch cohort 90 discontinued SB5, mainly due to adverse events (46/90) or secondary loss of response (37/90). Of the 225 patients in the SB5-start cohort, 81 discontinued SB5 resulting in SB5-drug persistence of 60.3% beyond one year. No differences in clinical remission (p = 0.53), C-reactive protein (CRP) (p = 0.80), faecal calprotectin (p = 0.40) and anti-drug antibody (ADA) trough levels (p = 0.55) were found between baseline, Week 26 and Week 52 following switch. Injection site pain was the most frequently reported adverse event.

In addition, ADA drug persistence (which may serve as a proxy for real-world therapeutic benefit and safety) after one year was 62.5% in the SB5-start cohort and 83.1% in the SB5 switch cohort.

The authors therefore concluded that ‘switching from the ADA originator to SB5 appeared effective and safe in this study with over 12 months of follow-up’. They added that ‘the most common adverse event was injection site pain; these patients were successfully moved on to ABP 501 [another adalimumab biosimilar] providing data about a double biosimilar switch, which seems to be safe’.

Conflict of interest
The authors of the research paper [1] reported conflict of interest, including having served on advisory boards, having served as a speaker, or received speaker fees, having received research and travel support, as well as acting as a consultant for pharmaceutical companies. For full details of the authors’ conflict of interest, see the research paper [1].

Editor’s comment
Readers interested to learn more about biosimilars for IBD are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

ECCO position statement on biosimilars

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 16]. Available from: www.gabionline.net/Biosimilars/General/biosimilars-approved-in-europe 
2. Derikx LAAP, Dolby HW, Plevris N, et al. Effectiveness and safety of adalimumab biosimilar SB5 in IBD: outcomes in originator to SB5 switch, double biosimilar switch and bio-naieve SB5 observational cohorts. J Crohns Colitis. 2021 Jun 5;jjab100. doi:10.1093/ecco-jcc/jjab100. Online ahead of print.
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Hadlima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 16]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-biosimilar-Hadlima 
4. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim finally signs licensing deal for Humira biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 16]. Available from: www.gabionline.net/es/Pharma-News/Boehringer-Ingelheim-finally-signs-licensing-deal-for-Humira-biosimilar

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