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Positive clinical data for three anti-TNF-α biosimilars Posted 29/07/2016

Results of studies of three biosimilars from Samsung Bioepis, Benepali (etanercept), Flixabi (infliximab) and candidate biosimilar SB5 (adalimumab), have shown ‘comparable outcomes with regards to both the efficacy and safety of treatment’ when compared to their respective reference products, according to the company [1-3].

The data was presented through seven poster presentations and an abstract publication presented at the European League Against Rheumatism (EULAR) 2016 Congress held in London, UK on 8–11 June 2016.

The poster presentations included switching data for Benepali (SB4), Flixabi (SB2) and SB5 obtained from 100-, 78- and 52-week phase III studies, respectively.

For the etanercept trial, 596 patients with moderate to severe RA despite methotrexate therapy were randomly assigned to receive weekly dose of 50 mg Benepali (SB4; N = 299) or Enbrel (N = 297) administered subcutaneously for 52 weeks. After 52 weeks, 245 patients participated in the extension study. 126 patients continued to receive SB4 (SB4/SB4) and 119 patients switched from Enbrel to SB4 (etanercept/SB4). Among them, 119 (94.4%) patients of SB4/SB4 and 113 (95.0%) patients of etanercept/SB4 completed the 100-week treatment. At Week 100, the efficacy, safety and immunogenicity profiles remained comparable between SB4/SB4 and etanercept/SB4 with ACR20 response rates of 77.9% and 79.1%, respectively. There were no treatment emergent issues, such as loss of efficacy, increase in adverse events or increase in immunogenicity [1].

For the infliximab trial, 584 patients with moderate to severe RA despite methotrexate therapy were randomized 1:1 to the two treatment arms and received either Flixabi (SB2; N = 291) or Remicade (N = 293) via intravenous infusion (3 mg/kg) at week 0, 2, 6 then every 8 weeks thereafter. At Week 54, 396 patients were re-randomized. 94 patients from Remicade were transitioned to SB2 (infliximab/SB2), 101 patients from infliximab continued to receive Remicade (infliximab/infliximab) and 201 patients from SB2 continued to receive SB2 (SB2/SB2). Up to Week 78, the efficacy, safety and immunogenicity profiles remained comparable between the infliximab/SB2, infliximab/infliximab and SB2/SB2. There were no treatment emergent issues or clinically relevant immunogenicity [2].

For the adalimumab trial, 508 patients with rheumatoid arthritis were randomized in a 1:1 ratio to receive either SB5 or Humira (adalimumab) 40 mg every other week via subcutaneous injection. At Week 24, 254 patients from SB5 continued to receive SB5 (SB5/SB5), 125 patients from Humira were transitioned to SB5 (adalimumab/SB5) and 129 patients from Humira continued to receive Humira (adalimumab/adalimumab). At Week 52, the efficacy, safety and immunogenicity profiles remained comparable between SB5/SB5, adalimumab/SB5 and adalimumab/adalimumab, with ACR20 response rates of 76.9%, 81.1% and 71.2%, respectively. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by switching. After transition up to Week 52, the incidence of anti-drug antibodies was 15.7% in SB5/SB5, 16.8% in adalimumab/SB5 and 18.3% in adalimumab/adalimumab [3].

Conflict of interest
The authors of the abstracts [1-3] have received grant/research support from Samsung Bioepis or are employees of Samsung Bioepis. Some of the authors have worked as consultants for Samsung Bioepis and other pharmaceutical companies. For full details of the authors’ conflicts of interest, see the abstracts [1-3].

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 to be preliminary until published in a peer-reviewed journal.

Related article
Benepali wins Danish tender for etanercept

References
1. Emery P, et al. Long-term safety and efficacy of SB4 (etanercept biosimilar) in patients with rheumatoid arthritis: comparison between continuing SB4 and switching from etanercept reference product to SB4. Poster [THU0150]. EULAR 2016; 8–11 June 2016; London, UK.
2. Smolen JS, et al. Comparable safety and immunogenicity and sustained efficacy after transition to SB2 (an infliximab biosimilar) vs ongoing infliximab reference product in patients with rheumatoid arthritis: results of phase III transition study. Poster [FRI0162]. EULAR 2016; 8–11 June 2016; London, UK.
3. Weinblatt M, et al. Sustained efficacy and comparable safety and immunogenicity after transition to SB5 (an adalimumab biosimilar) vs continuation of the adalimumab reference product in patients with rheumatoid arthritis: result of phase III study. Poster [FRI0161]. EULAR 2016; 8–11 June 2016; London, UK.

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Source: EULAR

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