The introduction of biological therapies based on tumor necrosis factor (TNF) inhibition
has revolutionized the management of Crohn's disease (CD) and ulcerative colitis (UC)
[
[1]
]. The originator of infliximab (IFX) (Remicade®) was the first biologic approved for
the treatment of moderate-to-severe forms of inflammatory bowel disease (IBD) in 1998.
It showed to be effective in improving several clinical outcomes, while the reduction
of surgery and hospitalization rates is debated [
[2]
]. Following the expiration of the patent of the originator product, several low-cost
biosimilars of IFX were rapidly developed. The IFX biosimilar CT-P13 (Inflectra® and
Remsima®) was the first to be approved in 2013 by the US Food and Drug Administration
and the European Medicines Agency. Equivalence of CT-P13 with the originator was shown
both in terms of safety and efficacy [
3
,
4
,
5
,
6
]. The second IFX biosimilar that received authorization for the treatment of IBD was
SB2 (Flixabi®), closely followed by PF-06438179/GP1111 (Zessly®). As for CT-P13, robust
clinical evidence has supported clinicians in increasing their confidence in the use
of these biosimilars for IBD treatment [
7
,
8
,
9
]. At our center, CT-P13 became available for clinical practice in July 2015, rapidly
replacing the originator product; SB2 and PF-06438179/GP1111 became available in August
2018 and June 2020, respectively. Only one IFX biosimilar was available at a time
at our hospital. Therefore, each new biosimilar progressively replaced the previous
one. All patients who were IFX-naïve were initiated with the newly available biosimilar,
while those already on treatment were progressively switched to the newly available
biosimilar. From March 2022, for the first time, two biosimilars of IFX - PF-06438179/GP1111
and SB2 – were available at the same time at our center. While safety and effectiveness
of switching from the IFX originator to one of its biosimilars have been widely demonstrated,
data on multiple switches from one biosimilar to another are more limited [
[10]
]. This paucity of clinical data has advised a prudent attitude towards multiple switching
from one biosimilar to another [
[11]
], including returning to a biosimilar previously used in the course of the medical
history of an IBD patient.To read this article in full you will need to make a payment
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References
- Biologic agents for IBD: practical insights.Nat Rev Gastroenterol Hepatol. 2015; 12: 537-545
- Systematic review with meta-analysis: comparative efficacy of immunosuppressants and biologics for reducing hospitalization and surgery in Crohn's disease and ulcerative colitis.Aliment Pharmacol Ther. 2017; 45: 3-13
- The PROSIT-BIO cohort: a prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilar.Inflamm Bowel Dis. 2017; 23: 233-243
- PROSIT Investigators. The PROSIT cohort of infliximab biosimilar in IBD: a prolonged follow-up on the effectiveness and safety across Italy.Inflamm Bowel Dis. 2019; 25: 568-579
- Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double- blind, non-inferiority trial.Lancet. 2017; 389: 2304-2316
- Effectiveness and safety of reference infliximab and biosimilar in Crohn disease: a French equivalence study.Ann Intern Med. 2019; 170: 99-107
- 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: 601-606
- The SPOSIB SB2 sicilian cohort: safety and effectiveness of infliximab biosimilar SB2 in inflammatory bowel diseases, including multiple switches.Inflamm Bowel Dis. 2021; 27: 182-189
- The 'totality-of-the-evidence' approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product.Therap Adv Gastroenterol. 2019; 121756284819852535
- Switching from biosimilar to biosimilar adalimumab, including multiple switching, in crohn's disease: a prospective study.J Clin Med. 2021; 10: 3387
- National patients’ association representatives; IG-IBD members. Use of biosimilars in inflammatory bowel disease: a position update of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD).Dig Liver Dis. 2019; 51: 632-639
Article info
Publication history
Published online: January 04, 2023
Accepted:
December 9,
2022
Received:
November 24,
2022
Publication stage
In Press Corrected ProofIdentification
Copyright
© 2022 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
