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

OBJECTIVE

To examine whether efficacy, safety and pharmacokinetic (PK) data observed with CT-P13 (Remsima(®); Inflectra(®)), an infliximab biosimilar, are similar to those from published reports with the reference medicinal product (RMP; Remicade(®)) 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.