The phase III, randomized, double-blind, parallel group, multicentre studies were designed to demonstrate the efficacy, safety, pharmacokinetics and immunogenicity of candidate infliximab biosimilar (SB2) compared to Remicade (infliximab), candidate etanercept biosimilar (SB4) compared to Enbrel (etanercept) and candidate adalimumab biosimilar (SB5) compared to Humira (adalimumab). The phase III trials were all carried out in subjects with moderate to severe rheumatoid arthritis despite methotrexate therapy. The trials were planned to be completed in November 2014 for SB4 and SB2, and in May 2015 for SB5.

The phase III results for SB4, SB2 and SB5 were presented at the 2015 Annual Meeting of the American College of Rheumatology (ACR) and the Association for Rheumatology Health Professionals (ARHP), which was held in San Francisco, USA on 6–11 November 2015.

Samsung Bioepis claims that the results demonstrate ‘sustained comparable safety profiles in 52- and 54-week clinical studies’ for their etanercept biosimilar SB4 and infliximab biosimilar SB2, respectively. They add that their adalimumab biosimilar SB5 ‘demonstrated both equivalent efficacy and comparable safety in a 24-week phase III clinical study’.

The 52-week SB4 study, which randomized 596 patients across 70 sites in 10 countries, showed an ACR20 (American College of Rheumatology 20% response criteria) response rate of 80.8% in the SB4 arm versus 81.5% in the Enbrel (etanercept) arm, fully supporting the 24-week study results of 78.1% and 80.3%, respectively [1].

The 54-week SB2 study, which randomized 584 patients across 73 sites in 11 countries, showed an ACR20 response rate of 65.3% in the SB2 arm versus 69.2% in the Remicade (infliximab) arm, fully supporting the 30-week study results of 64.1% and 66.0%, respectively [1].

The 24-week phase III study of SB5, which randomized 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy, showed an ACR20 response rate of 72.5% in the SB5 arm versus 72.0% in the Humira (adalimumab) arm. According to Samsung Bioepis the safety profile of SB5 was also comparable to Humira.

Editor's comment
It should be noted that data of the studies presented in this article were published as abstracts and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal. 

Related article
Phase I results for candidate adalimumab, etanercept and infliximab biosimilars

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for candidate etanercept and infliximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 20]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-candidate-etanercept-and-infliximab-biosimilars

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