Biosimilar etanercept was approved in Europe in January 2016 [1]. Researchers from the National Health Service (NHS) Foundation Trust and King’s College London, discuss the trials that led to the approval of biosimilar etanercept [2].
The biosimilar etanercept, Benepali (SB4), is produced by Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen Idec [3]. It is the first etanercept biosimilar to be approved in Europe.
Phase I data were published for pharmacokinetic equivalence in healthy volunteers at the European League Against Rheumatism (EULAR) conference in 2015, while results from the phase III equivalence trial were published in June 2016 [4]. The phase III trial enrolled 596 adult patients with moderate to severe rheumatoid arthritis despite methotrexate therapy who were biologically naïve. The patients were randomized to receive weekly doses of 50 mg of either the biosimilar (Benepali, SB4) or originator etanercept (Enbrel) administered subcutaneously for 52 weeks.
The primary endpoint was an ACR20 (20% improvement in American College of Rheumatology core set measurements) response at 24 weeks. The 95% confidence interval was -9.4% to +5.0% confirming equivalence. There were no differences in serious adverse event rates. During the study, 0.7% of Benepali patients and 13.1% of Enbrel patients had detectable anti-drug antibodies (ADAs) at any time point although none had persisting ADAs by week 24.
The high level of ADAs seen with Enbrel has been questioned although all antibodies were non-neutralizing and transient in nature. The presence of ADAs did not correlate with differential levels of clinical response. The authors also pointed out that ‘the evidence base for the etanercept biosimilar exceeds the evidence base that was available for Enbrel when it received its license 15 years ago!’.
Results of an extension study studied the effects of switching between the biosimilar and originator biologicals. 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 [4].
Conflict of interest
The authors of the research paper [2] declared that there were no conflicts of interest.
Editor’s comment
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Reducing healthcare costs and building trust in biosimilar medicines
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 11]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. Rutherford AI, Galloway JB. Biosimilars in rheumatology: out of the laboratory and into practice. Expert Rev Clin Immunol. 2016;12(7):697-9.
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 11]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-etanercept-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Positive clinical data for three anti-TNF-α biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 11]. Available from: www.gabionline.net/Biosimilars/Research/Positive-clinical-data-for-three-anti-TNF-a-biosimilars
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