Prospective study finds switching to biosimilar infliximab safe

Biosimilars/Research | Posted 28/04/2017 post-comment0 Post your comment

A study of the infliximab biosimilar Remsima has, according to the authors, shown similar ‘safety and survival’ of biosimilar infliximab Remsima compared to the originator biological Remicade [1].

Remsima V14A10

Remsima (CT-P13) was approved by the European Commission in September 2013 for all the indications of the reference biological, Johnson & Johnson and Merck’s Remicade (infliximab), in the European Union. These include treatment of ankylosing spondylitis (AS), Crohn’s disease, psoriatic arthritis, psoriasis, rheumatoid arthritis and ulcerative colitis [2].

The study included 78 patients who began treatment with Remsima since March 2015. Of these, 25 were suffering from rheumatoid arthritis, 8 from psoriatic arthritis, 41 from spondyloarthropathies and 2 from severe uveitis. A total of 53 of these patients had already been treated with Remicade and 25 were ‘naïve’ to infliximab.

At nine months the overall survival rate was 86%, with only 23% of patients needing glucocorticoid use at nine months. The infusion period for Remsima had to be reduced to seven weeks or less in 22% of patients. Finally in 4 patients an optimization of treatment extending to more than 8 weeks was achieved. A small variation of CRP level (Δ < 5 mg/dL) at 9 months of initiation of Remsima treatment was also observed.

The authors concluded that ‘The results of safety and survival of biosimilar infliximab Remsima are similar to those shown in their pivotal trials PLANETRAS and PLANETAS’. They added that ‘these data support an increasingly widespread use of this biosimilar in any patient profile’.

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

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

Related article
Biosimilars of infliximab

1. Rubio E, et al. AB0310 Prospective Study of 78 patients treated with infliximab biosimilar Remsima. Annal Rheum Dis. 2017;75(2).
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 28]. Available from:

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