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Interchangeability between infliximab biosimilars with respect to immunogenicity Posted 01/06/2018

In their editorial, Katsanos and colleagues [1] discuss a study carried out by Italian and Spanish researchers on the immunogenicity of infliximab biosimilars that finds that there is full interchangeability between infliximab biosimilars with respect to immunogenicity [2].

Remicade (infliximab) was the first antitumour necrosis factor (anti-TNF) available to treat inflammatory bowel disease (IBD). The infliximab biosimilar Remsima/Inflectra (CT‑P13) was approved in Europe in September 2013 and in the US in April 2016. Meanwhile, the infliximab biosimilar SB2 was approved in Europe in May 2016 as Flixabi and in the US in April 2017 [3].

Recent data suggest that both biosimilars are equally safe and effective, with comparable immunogenicity to Remicade. However, these data have predominately been extrapolated from rheumatoid arthritis. In their study, Fiorino et al. assess whether antibodies to infliximab cross-react with Remicade, CT‑P13 and SB2 in IBD.

The study population consisted of all ATI-positive patients (n = 34) from BIOSIM-01, a retrospective cohort study conducted at the Humanitas Clinical and Research Institute (Rozzano (MI), Italy). This cohort included 100 consecutive adult IBD patients treated with infliximab (switched from Remicade to CT‑P13, n = 18; only treated with CT‑P13 and never exposed to the originator, n = 52; only treated with Remicade and never exposed to any biosimilar, n = 30) between March 2015 and November 2016.

Remicade and CT‑P13 have been shown to have a comparable efficacy and safety profile [4] and a single switch from Remicade to CT‑P13 has been found to be a valid therapeutic option [5 ,6]. The landmark NOR-SWITCH randomized controlled trial also showed that a single switch from Remicade to CT‑P13 is not inferior to continued treatment with the infliximab originator, in terms of disease worsening [7]. Nevertheless, there are no data regarding multiple switches (between originator and biosimilar or various biosimilars). Furthermore, long-term (over a year) efficacy and safety data are lacking. Consequently, cross-switching (switching between two biosimilars), reverse switching (switching from a biosimilar to its originator), or multiple/repeated switching is not currently advised [8].

In the study by Fiorino et al., 76 out of 152 infliximab-treated patient samples were infliximab positive (Remicade, n = 30; CT‑P13, n = 14; switchers, n = 32). The authors noted that all antibodies cross-reacted with any type of infliximab molecule. That is, all antibodies developed against Remicade identically cross-reacted with CT‑P13 or SB2, and vice versa for all three molecules.

The authors concluded that these results suggests that if you have already developed antibodies to one infliximab product, there is no point in switching to another infliximab product. This is in line with another study that also found that switching may not be suitable for patients with immunogenicity [9].

Katsanos and colleagues ended their editorial saying that ‘larger prospective studies, especially in the area of therapeutic drug monitoring, are urgently awaited to guide physicians on therapeutic decision-making, as therapeutic drug monitoring will also play a key role in the management of IBD patients on biosimilars’.

Conflict of interest
Some of the authors of the research paper [1] reported conflict of interest, including having received consultancy fees from AbbVie, Janssen, Takeda, Ferring, Miraca, AMAG and Pfizer.

For full details of the authors’ conflict of interest, see the research paper [1].

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References
1. Katsanos KH, Papamichael K, Cheifetz AS, Christodoulou DK. Full interchangeability in regards to immunogenicity between the infliximab reference biologic and biosimilars CT-P13 and SB2 in inflammatory bowel disease. Inflamm Bowel Dis. 2018;24(3):465-6.
2. Fiorino G, Ruiz-Argüello MB, Maguregui A, et al. Full interchangeability in regard to immunogenicity between the infliximab reference biologic and biosimilars CT-P13 and SB2 in inflammatory bowel disease. Inflamm Bowel Dis. 2018;24(3):601-6.
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of infliximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-infliximab
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab safe and effective in IBD [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 1]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-infliximab-safe-and-effective-in-IBD
5. GaBI Online - Generics and Biosimilars Initiative. Switching from reference infliximab to CT P13 in IBD patients [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 1]. Available from: www.gabionline.net/Biosimilars/Research/Switching-from-reference-infliximab-to-CT-P13-in-IBD-patients
6. GaBI Online - Generics and Biosimilars Initiative. Switching to biosimilar infliximab in IBD patients [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 1]. Available from: www.gabionline.net/Biosimilars/Research/Switching-to-biosimilar-infliximab-in-IBD-patients
7. GaBI Online - Generics and Biosimilars Initiative. NOR-SWITCH study finds biosimilar infliximab not inferior to originator [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 1]. Available from: www.gabionline.net/Biosimilars/Research/NOR-SWITCH-study-finds-biosimilar-infliximab-not-inferior-to-originator
8. GaBI Online - Generics and Biosimilars Initiative. European IBD specialists support switching to biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 1]. Available from: www.gabionline.net/Biosimilars/General/European-IBD-specialists-support-switching-to-biosimilars
9. GaBI Online - Generics and Biosimilars Initiative. Switching may not be suitable for patients with immunogenicity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 1]. Available from: www.gabionline.net/Biosimilars/Research/Switching-may-not-be-suitable-for-patients-with-immunogenicity

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