Skip to main content
Erschienen in: Current Treatment Options in Gastroenterology 1/2018

01.03.2018 | Inflammatory Bowel Disease (G Lichtenstein, Section Editor)

Biosimilars in the Treatment of Inflammatory Bowel Disease: Supporting Evidence in 2017

verfasst von: Frank I. Scott, MD MSCE, Gary R. Lichtenstein, MD

Erschienen in: Current Treatment Options in Gastroenterology | Ausgabe 1/2018

Einloggen, um Zugang zu erhalten

Abstract

Purpose of Review

Monoclonal antibodies targeting tumor necrosis factor-alpha, integrin molecules, and interleukin-12/23 have become backbone therapies for Crohn’s disease and ulcerative colitis. While clinically effective, these biologic therapies come with significant expense, contributing to overall healthcare spending in the USA. Biosimilars have the potential to significantly reduce expenditures secondary to the use of biologic medications such as infliximab and adalimumab, though their complicated manufacturing process results in inherent differences in structure when compared to the originator compounds. In this article, we review the available literature regarding biosimilars in IBD.

Recent Findings

Several biosimilar agents to infliximab and adalimumab are currently FDA-approved, with many more currently in development. Initial clinical trials for approval have been conducted in one of the original indications for each originator biologic. There are growing data demonstrating similar clinical efficacy, immunogenicity, and safety of each of the approved infliximab and adalimumab biosimilars, both through indication extrapolation from other diseases such as rheumatoid arthritis and ankylosing spondylitis, as well observational data in patients with inflammatory bowel disease. Further research is ongoing regarding the efficacy and safety of substitution and interchangeability of biosimilars, as well as therapeutic drug monitoring for biosimilar agents.

Summary

Research to date supports the utilization of reference biologics and biosimilars for new initiators, while additional data are being accrued regarding the interchangeability between these agents.
Literatur
12.
Zurück zum Zitat Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72(10):1605–12. https://doi.org/10.1136/annrheumdis-2012-203091. This clinical trial was the first demonstrating the efficacy of CT-P13 in ankylosing spondylitis. The primary findings of similar efficacy, safety, and immunogenicity compared to reference infliximab were used as significant evidence in the approval of CT-P13 for ankylosing spondylitis as well as for indication extrapolation to inflammatory bowel disease.CrossRefPubMedPubMedCentral Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72(10):1605–12. https://​doi.​org/​10.​1136/​annrheumdis-2012-203091. This clinical trial was the first demonstrating the efficacy of CT-P13 in ankylosing spondylitis. The primary findings of similar efficacy, safety, and immunogenicity compared to reference infliximab were used as significant evidence in the approval of CT-P13 for ankylosing spondylitis as well as for indication extrapolation to inflammatory bowel disease.CrossRefPubMedPubMedCentral
13.
Zurück zum Zitat Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72(10):1613–20. https://doi.org/10.1136/annrheumdis-2012-203090. This clinical trial, like PLANETAS, demonstrated similar efficacy, safety and immunogenicity of CT-P13 in rheumatoid arthritis. These findings were also important in the approval of CT-P13 and subsequent indication extrapolation to inflammatory bowel disease.CrossRefPubMedPubMedCentral Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72(10):1613–20. https://​doi.​org/​10.​1136/​annrheumdis-2012-203090. This clinical trial, like PLANETAS, demonstrated similar efficacy, safety and immunogenicity of CT-P13 in rheumatoid arthritis. These findings were also important in the approval of CT-P13 and subsequent indication extrapolation to inflammatory bowel disease.CrossRefPubMedPubMedCentral
14.
Zurück zum Zitat Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017;76(1):58–64. https://doi.org/10.1136/annrheumdis-2015-207764.CrossRefPubMed Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017;76(1):58–64. https://​doi.​org/​10.​1136/​annrheumdis-2015-207764.CrossRefPubMed
19.
Zurück zum Zitat Cohen S, Alonso-Ruiz A, Klimiuk PA, Lee E, Peter N, Sonderegger I, et al. FRI0189 Similar efficacy and safety of biosimilar candidate BI 695501 and adalimumab originator reference product in patients with moderate to severe active rheumatoid arthritis: 24 week results from a phase III clinical study (voltaire®-ra). Ann Rheum Dis. 2017;76(Suppl 2):553. Cohen S, Alonso-Ruiz A, Klimiuk PA, Lee E, Peter N, Sonderegger I, et al. FRI0189 Similar efficacy and safety of biosimilar candidate BI 695501 and adalimumab originator reference product in patients with moderate to severe active rheumatoid arthritis: 24 week results from a phase III clinical study (voltaire®-ra). Ann Rheum Dis. 2017;76(Suppl 2):553.
29.
30.
Zurück zum Zitat Sieczkowska J, Jarzebicka D, Banaszkiewicz A, Plocek A, Gawronska A, Toporowska-Kowalska E, et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations. J Crohn's Colitis. 2016;10(2):127–32. https://doi.org/10.1093/ecco-jcc/jjv233.CrossRef Sieczkowska J, Jarzebicka D, Banaszkiewicz A, Plocek A, Gawronska A, Toporowska-Kowalska E, et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations. J Crohn's Colitis. 2016;10(2):127–32. https://​doi.​org/​10.​1093/​ecco-jcc/​jjv233.CrossRef
32.
Zurück zum Zitat Smits LJ, Derikx LA, de Jong DJ, Boshuizen RS, van Esch AA, Drenth JP, et al. Clinical outcomes following a switch from Remicade(R) to the biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study. J Crohn's Colitis. 2016;10(11):1287–93. https://doi.org/10.1093/ecco-jcc/jjw087.CrossRef Smits LJ, Derikx LA, de Jong DJ, Boshuizen RS, van Esch AA, Drenth JP, et al. Clinical outcomes following a switch from Remicade(R) to the biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study. J Crohn's Colitis. 2016;10(11):1287–93. https://​doi.​org/​10.​1093/​ecco-jcc/​jjw087.CrossRef
37.
Zurück zum Zitat Smits LJT, Grelack A, Derikx L, de Jong DJ, van Esch AAJ, Boshuizen RS, et al. Long-term clinical outcomes after switching from Remicade(R) to biosimilar ct-p13 in inflammatory bowel disease. Digestive diseases and sciences. 2017. Smits LJT, Grelack A, Derikx L, de Jong DJ, van Esch AAJ, Boshuizen RS, et al. Long-term clinical outcomes after switching from Remicade(R) to biosimilar ct-p13 in inflammatory bowel disease. Digestive diseases and sciences. 2017.
38.
Zurück zum Zitat Gonczi L, Gecse KB, Vegh Z, Kurti Z, Rutka M, Farkas K, et al. Long-term efficacy, safety, and immunogenicity of biosimilar infliximab after one year in a prospective nationwide cohort. Inflammatory bowel diseases. 2017. Gonczi L, Gecse KB, Vegh Z, Kurti Z, Rutka M, Farkas K, et al. Long-term efficacy, safety, and immunogenicity of biosimilar infliximab after one year in a prospective nationwide cohort. Inflammatory bowel diseases. 2017.
41.
Zurück zum Zitat Dörner T, Kay J. Biosimilars in rheumatology: current perspectives and lessons learnt. Nat Rev Rheumatol. 2015;11(12):713–724. Dörner T, Kay J. Biosimilars in rheumatology: current perspectives and lessons learnt. Nat Rev Rheumatol. 2015;11(12):713–724.
42.
Zurück zum Zitat U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research (CBER). Considerations in demonstrating interchangeability with a reference product: guidance for industry. Silver Spring (MD); 2017 January 2017. U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research (CBER). Considerations in demonstrating interchangeability with a reference product: guidance for industry. Silver Spring (MD); 2017 January 2017.
43.
Zurück zum Zitat Jorgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, et al. 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(10086):2304–16. https://doi.org/10.1016/S0140-6736(17)30068-5. The NORSWITCH trial is the largest conducted trial of biosimilar interchangeability in autoimmune diseases. This pivotal study provides the first evidence that induction with an originator biologic and subsequent transition to a biosimilar may be safe. Further research is ongoing regarding multiple changes between biosimialrs as well as interchangeability for biosimilars other than CT-P13.CrossRefPubMed Jorgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, et al. 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(10086):2304–16. https://​doi.​org/​10.​1016/​S0140-6736(17)30068-5. The NORSWITCH trial is the largest conducted trial of biosimilar interchangeability in autoimmune diseases. This pivotal study provides the first evidence that induction with an originator biologic and subsequent transition to a biosimilar may be safe. Further research is ongoing regarding multiple changes between biosimialrs as well as interchangeability for biosimilars other than CT-P13.CrossRefPubMed
51.
Zurück zum Zitat Malickova K, Duricova D, Kolar M, Bortlik M, Hruba V, Machkova N, et al. No difference in immunogenicity of the original and biosimilar infliximab in patients with inflammatory bowel disease: short-term results. Proceedings from the European Crohn’s and Colitis Organisation; March 16–19. 2016:P311. Malickova K, Duricova D, Kolar M, Bortlik M, Hruba V, Machkova N, et al. No difference in immunogenicity of the original and biosimilar infliximab in patients with inflammatory bowel disease: short-term results. Proceedings from the European Crohn’s and Colitis Organisation; March 16–19. 2016:P311.
Metadaten
Titel
Biosimilars in the Treatment of Inflammatory Bowel Disease: Supporting Evidence in 2017
verfasst von
Frank I. Scott, MD MSCE
Gary R. Lichtenstein, MD
Publikationsdatum
01.03.2018
Verlag
Springer US
Erschienen in
Current Treatment Options in Gastroenterology / Ausgabe 1/2018
Print ISSN: 1092-8472
Elektronische ISSN: 1534-309X
DOI
https://doi.org/10.1007/s11938-018-0177-z

Weitere Artikel der Ausgabe 1/2018

Current Treatment Options in Gastroenterology 1/2018 Zur Ausgabe

Inflammatory Bowel Disease (G Lichtenstein, Section Editor)

Management of Anemia in Patients with Inflammatory Bowel Disease (IBD)

Colon (JC Anderson, Section Editor)

Management of Serrated Polyps of the Colon

Inflammatory Bowel Disease (G Lichtenstein, Section Editor)

Novel Therapies and Treatment Strategies for Patients with Inflammatory Bowel Disease

Inflammatory Bowel Disease (G Lichtenstein, Section Editor)

Updates on Women’s Health Issues in Patients with Inflammatory Bowel Disease

Esophagus (PG Iyer, Section Editor)

Emerging Insights into the Esophageal Microbiome

Leitlinien kompakt für die Innere Medizin

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Update Innere Medizin

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.