South Korean biotechnology company Celltrion presented results of clinical experience for its infliximab biosimilar Remsima (CT-P13) at Digestive Diseases Week (DDW) 2015, which was held in Washington DC, USA, on 17–19 May 2015.
Professor Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo, Norway, presented results during a satellite symposium hosted by Celltrion showing that Remsima biosimilar infliximab was comparable to the reference biological (Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade) in terms of efficacy and safety.
Clinical data in 78 inflammatory bowel disease (IBD) patients in Norway [46 with Crohn’s disease (CD) and 32 with ulcerative colitis (UC)] showed a statistically significant reduction in disease activity at week 14. Among them, 22 patients (8 UC and 14 CD) were previously treated with other biologicals. Of the patients with CD, 76% (32/42) were in clinical remission (HBI score ≤ 4) at week 14 after three infusions of biosimilar infliximab, with significant reductions also seen in calprotectin and CRP. For UC patients, 56% (18/32) were in clinical remission at week 14 (partial Mayo score ≤ 2) following the three infusions, with significant reductions in Simple Activity Index, calprotectin and CRP.
Celltrion gained European approval for the world’s first monoclonal antibody biosimilar Remsima/Inflectra (infliximab) as part of its collaboration with US-based generics maker Hospira in September 2013 [1]. In Europe, as well as in Korea and Japan, the biosimilar was approved for all indications of the originator product Remicade. However, in Canada, extrapolation* from autoimmune arthritis to IBD was not granted [2].
The European Medicines Agency has defended its decision to approve Remsima/Inflectra in extrapolated indications and has presented scientific arguments to support the extrapolation [3]. Despite such reassurances, some have still questioned whether extrapolation from autoimmune arthritis to IBD can be justified on safety grounds, and have even recommended against its use in IBD [4, 5].
This real-life data in IBD patients may alleviate fears concerning the extrapolation of biosimilars to all indications of the reference biological.
Data from two posters on the safety and efficacy of biosimilar infliximab patients with CD and UC were also presented at DDW 2015.
Celltrion applied for approval of Remsima in the US in August 2014 [6].
*Extrapolation involves extending and applying the data from clinical studies regarding one medical condition to another medical condition.
Conflict of interest
The presenter, Professor Jørgen Jahnsen, did not provide the conflict of interest statement.
Editor’s comment
It should be noted that data of the study presented in this article were published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
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References
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