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

초록

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.

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