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Subcutaneous Infliximab, CT-P13 SC: A Profile of Its Use in the EU

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Abstract

CT-P13 (Remsima®; Inflectra®), a biosimilar of reference infliximab (Remicade®), provides a useful alternative for patients requiring infliximab therapy and, as with other biosimilar agents, has the potential to reduce treatment costs. Furthermore, the availability of CT-P13 in a subcutaneous formulation (CT-P13 SC), with the possibility (after adequate training) of self-administration at home, has the potential to both improve patient convenience and reduce the burden on the healthcare system. The initial approval of CT-P13 SC, for use in the treatment of rheumatoid arthritis in adults, was based on the findings of a randomised, double-blind phase I/III trial which demonstrated the non-inferiority of CT-P13 SC administered once every 2 weeks to intravenous CT-P13 (CT-P13 IV) administered once every 8 weeks in reducing disease activity in patients with active rheumatoid arthritis. Subsequently, based on pharmacokinetic data in patients with inflammatory bowel disease, CT-P13 SC has also been approved in the EU for use in the treatment of Crohn’s disease, ulcerative colitis and, by extrapolation, ankylosing spondylitis, psoriatic arthritis and psoriasis, in adults.

Plain Language Summary

Biosimilars are biological medical agents that are designed to closely replicate a reference medicine while potentially reducing treatment costs. CT-P13 (Remsima®; Inflectra®) in the intravenous formulation (CT-P13 IV) is a biosimilar of reference infliximab (Remicade®) and is approved in the EU for use in the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis in adults and Crohn’s disease and ulcerative colitis in children aged ≥ 6 years. Unlike reference infliximab, CT-P13 is now also available in a formulation that can be administered by subcutaneous injection (CT-P13 SC). CT-P13 SC is approved for use in adults (only) in all indications as for CT-P13 IV, with approval based on clinical trials which showed that the subcutaneous formulation has non-inferior efficacy to CT-P13 IV in the treatment of rheumatoid arthritis and has non-inferior pharmacokinetics to the intravenous formulation in patients with inflammatory bowel disease. In conclusion, CT-P13 SC provides a useful alternative for adult patients requiring infliximab therapy and, with the possibility of self-administration at home, has the potential both to improve patient convenience and to reduce the burden on the healthcare system.

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Acknowledgments

The article was reviewed by: R. Alten, Internal Medicine, Rheumatology, Clinical Immunology and Osteology, Schlosspark-Klinik, Charité University Medicine Berlin, Berlin, Germany; A. Conti, Department of Surgery, Dermatologic Unit, Infermi Hospital, AUSL Romagna, Rimini, Italy. During the peer review process, Celltrion Healthcare Co., Ltd was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Matt Shirley

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Correspondence to Matt Shirley.

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Matt Shirley is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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Shirley, M. Subcutaneous Infliximab, CT-P13 SC: A Profile of Its Use in the EU. Clin Drug Investig 41, 1099–1107 (2021). https://doi.org/10.1007/s40261-021-01093-8

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