Reverse switching from the biosimilar SB2 to the originator infliximab in previously switched patients with inflammatory bowel diseases: results of a prospective long-term cohort study

Fischer S, Donhauser M, Cohnen SE, Fietkau K, Vetter M, Grübel-Liehr M, Dietrich P, Rath T, Wilfer A, Sologub L, Krebs S, Dörje F, Nagore D, Meyer S, Neurath M, Atreya R (2024)

Publication Type: Journal article

Publication year: 2024

Journal

Therapeutic Advances in Gastroenterology SAGE Publications

Book Volume: 17

DOI: 10.1177/17562848241301887

Abstract

A clinical study investigating the interchangeability between infliximab, a previously patented biotechnological produced drug (biological) and its successor product biosimilar SB2, which is highly similar to the existing reference product, in the treatment of patients with inflammatory bowel diseases

Why was the study done? Biological drugs (like infliximab) are produced using various methods under the involvement of biotechnology. In contrary to generic drugs, due to their complex structure, biosimilars are not exactly the same molecule as the original substance. After the introduction of biosimilars, which are mostly less expensive than the original product, concerns were raised regarding the interchangeability of these substances. This study was conducted to investigate potential changes in efficacy and safety after multiple, so called switches (from the original product to its biosimilar and back). What did the researchers do? The research team switched a group of 95 patients diagnosed with inflammatory bowel disease and therefore treated with the original biologic drug infliximab to the biosimilar SB2, reverse switched them back to the original drug after 96 weeks and observed the patients for another 48 weeks. During the observational phase the disease activity, drug levels and potential side effects were monitored. What did the researchers find? The initial and the reverse switch had no relevant impact on the course of disease and additionally no safety issues occurred. During the 48 weeks observational period, 14.7% of patients discontinued therapy, which was not out of the expected range. Most potential side effects were not considered to be therapy-associated and only 4 of 95 patients discontinued treatment due to safety concerns. The drug levels remained stable during the switches. What do the findings mean? In this study, the research team found no impact of multiple switches on the disease activity in inflammatory bowel disease patients and moreover no safety issues. These findings support the practice of switching between the biologic originator substance infliximab and its biosimilars.

Authors with CRIS profile

Sarah Fischer Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology Moritz Donhauser Department of Orthopaedic and Trauma Surgery Sarah Ellen Mesfin Professur für Translationale Immunforschung bei chronisch entzündlichen Darmerkrankungen Marcel Vetter Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology Peter Dietrich Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology Timo Rath Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology Frank Dörje Lehrstuhl für Pharmazeutische Technologie und Biopharmazie Sebastian Meyer Lehrstuhl für Biometrie und Epidemiologie (IMBE) Markus Neurath Lehrstuhl für Innere Medizin I (Medizin 1) Raja Atreya Professur für Translationale Immunforschung bei chronisch entzündlichen Darmerkrankungen

Additional Organisation(s)

FAU Forschungszentrum Neue Wirkstoffe (FAU NeW)

Involved external institutions

Progenika Biopharma ES Spain (ES)

How to cite

APA:

Fischer, S., Donhauser, M., Cohnen, S.E., Fietkau, K., Vetter, M., Grübel-Liehr, M.,... Atreya, R. (2024). Reverse switching from the biosimilar SB2 to the originator infliximab in previously switched patients with inflammatory bowel diseases: results of a prospective long-term cohort study. Therapeutic Advances in Gastroenterology, 17. https://doi.org/10.1177/17562848241301887

MLA:

Fischer, Sarah, et al. "Reverse switching from the biosimilar SB2 to the originator infliximab in previously switched patients with inflammatory bowel diseases: results of a prospective long-term cohort study." Therapeutic Advances in Gastroenterology 17 (2024).

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