S Schreiber1. 1. Klinik für Innere Medizin I, Christian-Albrechts-Universität zu Kiel, Universitätsklinikum Schleswig-Holstein, Schittenhelmstr.12, 24105, Kiel, Deutschland. sekretariat@mucosa.de.
Abstract
BACKGROUND: The expiry of the patent for tumor necrosis factor (TNF)-binding antibodies allowed the approval of biosimilars. OBJECTIVES: Assessment and discussion of specific aspects of anti-TNF biosimilars in the therapy of inflammatory bowel diseases. METHODS: Review and discussion of currently available literature. RESULTS: The use of TNF-binding antibodies differs between the therapy of rheumatoid disorders and inflammatory bowel diseases. Clinical proof of efficacy for biosimilars for infliximab has been achieved in rheumatoid diseases because activity indices are more stable than in inflammatory bowel diseases and require extrapolation. The TNF-binding antibodies, in particular infliximab, adalimumab and golimumab play a central role in the first-line therapy of inflammatory bowel diseases. CONCLUSION: The use of TNF-binding biosimilars for patients suffering from inflammatory bowel diseases is possible through extrapolation. Competition should not only drive a price reduction but also a better clinical profiling of anti-TNF therapy for patients with inflammatory bowel diseases. Missing information for "best use" include optimal strategies for dosing and timing for introduction during the course of Crohn's disease and ulcerative colitis.
BACKGROUND: The expiry of the patent for tumor necrosis factor (TNF)-binding antibodies allowed the approval of biosimilars. OBJECTIVES: Assessment and discussion of specific aspects of anti-TNF biosimilars in the therapy of inflammatory bowel diseases. METHODS: Review and discussion of currently available literature. RESULTS: The use of TNF-binding antibodies differs between the therapy of rheumatoid disorders and inflammatory bowel diseases. Clinical proof of efficacy for biosimilars for infliximab has been achieved in rheumatoid diseases because activity indices are more stable than in inflammatory bowel diseases and require extrapolation. The TNF-binding antibodies, in particular infliximab, adalimumab and golimumab play a central role in the first-line therapy of inflammatory bowel diseases. CONCLUSION: The use of TNF-binding biosimilars for patients suffering from inflammatory bowel diseases is possible through extrapolation. Competition should not only drive a price reduction but also a better clinical profiling of anti-TNF therapy for patients with inflammatory bowel diseases. Missing information for "best use" include optimal strategies for dosing and timing for introduction during the course of Crohn's disease and ulcerative colitis.
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