Real world switching data for etanercept biosimilar Benepali

Biosimilares/Investigación | Posted 14/07/2017 post-comment0 Post your comment

Real world evidence from a study of etanercept biosimilar Benepali (SB4) compared to Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept) have demonstrated ‘sustained efficacy and safety, and high acceptance and adherence in patients initiating treatment with Benepali (etanercept)’, according to Biogen.

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Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Benepali is made by Samsung Bioepis (a joint venture between biotechnology company Biogen and South Korean electronics giant Samsung) and was approved in the European Union (EU) in January 2016 [1].

Data from different studies involving switching to Benepali were presented at the Annual European Congress of Rheumatology (EULAR) 2017, which was held on 14−17 June in Madrid, Spain.

Two real world studies evaluated the safety and efficacy of Benepali in patients following a switch from originator etanercept (Enbrel). In a study of 1,548 patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (SpA) from the DANBIO registry, Biogen reports that ‘disease activity was shown to be largely unaffected at 3 months post-switch and comparable to that observed in the 3 months prior to switching’ [2]. Furthermore, the company adds that ‘in a separate cohort of 92 patients with RA, PsA or ankylosing spondylitis (AS) in the UK, a low rate of treatment discontinuations due to inefficacy or adverse events was demonstrated at 6 months post-switch’.

Other real world data highlights ‘the acceptance of Benepali and adherence to treatment among patients who were switched’ from originator etanercept (Enbrel), according to Biogen. In one UK study of 96 adult patients treated for RA, PsA or AS, 99% agreed to switch and 91% of the group remained on Benepali at 6 months. In another study of 643 patients with rheumatic disease in The Netherlands, 99% (636 patients) agreed to switch to Benepali from originator etanercept (Enbrel). At 3 months, 36 of the 636 patients had discontinued treatment. Both studies, according to Biogen, ‘reflect that treatment with Benepali provides persistency within the expectations of the reference product’.

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar etanercept offered at 47% discount in Norway []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 14]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Danish infliximab switching study shows no difference []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 14]. Available from:

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Source: Biogen

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