Positive phase III switching results for Celltrion’s infliximab biosimilar Posted 08/12/2017

Results of a phase III extension study have shown that Celltrion Healthcare’s (Celltrion) infliximab biosimilar (CT-P13) is shown to be comparable in efficacy and safety to Johnson & Johnson/Merck’s Remicade in switched inflammatory bowel disease patients, according to the South Korean biotechnology company.

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.

The phase III extension of the randomized controlled switching trial included 220 patients with moderate to severe Crohn’s disease (CD) and followed them for a 54‑week treatment period, following a switch from reference infliximab at week 30. Patients were randomly assigned to four groups (maintained groups [CT‑P13 and reference infliximab] and switched groups [reference infliximab to CT‑P13 and CT‑P13 to reference infliximab]) in a double-blinded manner.

The results were presented at the 25th United European Gastroenterology Week Congress, which was held on 28 October – 1 November 2017 in Barcelona, Spain

According to Celltrion, ‘efficacy, pharmacokinetics and safety were comparable among all treatment groups up to week 30.’ In addition, ‘the Crohn’s Disease Activity Index‑70 (CDAI‑70) response, clinical remission and the Short Inflammatory Bowel Disease questionnaire (SIBDQ) score, a measure of quality of life for people with inflammatory bowel disease, were similar among all groups at each measured time point up to week 54’.

The safety profiles among all treatment groups, including adverse reactions, serious adverse events, infections and immunogenicity were also similar throughout the one-year treatment period.

This study follows on from the positive findings in the NOR-SWITCH study [1] and should go some way to reassuring gastroenterologists about the safety of switching patients to biosimilar infliximab.

Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. NOR-SWITCH study finds biosimilar infliximab not inferior to originator [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Dec 8]. Available from: www.gabionline.net/Biosimilars/Research/NOR-SWITCH-study-finds-biosimilar-infliximab-not-inferior-to-originator

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Source: Celltrion

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