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Analysis of clinical trials of biosimilar infliximab (CT-P13) and comparison against historical clinical studies with the infliximab reference medicinal product

Title
Analysis of clinical trials of biosimilar infliximab (CT-P13) and comparison against historical clinical studies with the infliximab reference medicinal product
Author
유대현
Keywords
ankylosing spondylitis; biosimilar; CT-P13; efficacy; infliximab; literature search; pharmacokinetics; rheumatoid arthritis; safety
Issue Date
2015-10
Publisher
EXPERT REVIEWS
Citation
EXPERT REVIEW OF CLINICAL IMMUNOLOGY, v. 11, NO Special SI, Page. 15-24
Abstract
Objective: To examine whether efficacy, safety and pharmacokinetic (PK) data observed with CT-P13 (Remsima (R); Inflectra (R)), an infliximab biosimilar, are similar to those from published reports with the reference medicinal product (RMP; Remicade (R)) in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS). Methods: Literature searches were performed to identify clinical studies with infliximab RMP. Efficacy, safety and PK data were indirectly compared with data from head-to-head clinical trials of CT-P13 and RMP. Results: CT-P13 and RMP produce similar efficacy in patients with RA and AS when compared across clinical studies. There are no substantial differences in the incidence of infusion-related reactions, infections, serious infections, malignancy or lymphoma. PK data in patients with RA are similar in direct comparisons and comparisons with historical data. Conclusion: Efficacy, safety and PK data are highly comparable between CT-P13 and RMP, both in head-to-head clinical studies, and indirect comparisons with historical clinical data for RMP.
URI
http://www.tandfonline.com/doi/full/10.1586/1744666X.2015.1090314http://hdl.handle.net/20.500.11754/28355
ISSN
1744-666X; 1744-8409
DOI
10.1586/1744666X.2015.1090314
Appears in Collections:
COLLEGE OF MEDICINE[S](의과대학) > MEDICINE(의학과) > Articles
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