In 2015, the rheumatology community saw the emergence of the first biosimilars onto the market. Biosimilars are not new to the medical community at large, having been on the market in the European Union (EU) since 2006. However, their arrival into the field of rheumatology is new and, according to researchers from the National Health Service (NHS) Foundation Trust and King's College London, ‘comes with great anticipation’ [1].
Both etanercept and infliximab have been used to treat rheumatic diseases for many years. The originator infliximab biological, Johnson & Johnson/Merck’s Remicade, was approved by the European Medicines Agency (EMA) in August 1999. The patents on Remicade expired in Europe in February 2015 [2]. In March 2015, Celltrion/Hospira’s biosimilar infliximab, Remsima/Inflectra was launched in the UK. In the UK, a 100 mg vial of Remicade costs GBP 419.62, whereas the list price of a 100 mg vial of Remsima and Inflectra is only GBP 377.66. Local agreements further reduce the cost, with discounts approaching 50% of the cost of the original Remicade price [3].
The originator etanercept biological, Amgen/Pfizer’s Enbrel, was approved by EMA in February 2000. The patents on Enbrel expired in Europe in August 2015 [2]. The first etanercept biosimilar, Benepali from Samsung Bioepis, was authorized in Europe in January 2016 [4]. EMA also accepted an application from Sandoz, the generics division of Novartis, for its etanercept biosimilar (GP2015) in December 2015 [5].
In the following series of five articles on how biosimilars compare to generics, study design for biosimilar trials and extrapolation for biosimilars, as well as trial data used to support the biosimilar infliximab and etanercept approvals, are discussed.
Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.
Editor’s comment
Readers interested to learn more about the infliximab and etanercept biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
The anti-TNF biosimilar CT-P13 had comparable efficacy to infliximab in rheumatoid arthritis over one year
Reducing healthcare costs and building trust in biosimilar medicines
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Trials for biosimilar etanercept
Trials for biosimilar infliximab
Study design for biosimilar trials
Biosimilars versus generics
References
1. Rutherford AI, Galloway JB. Biosimilars in rheumatology: out of the laboratory and into practice. Expert Rev Clin Immunol. 2016;12(7):697-9.
2. Derbyshire M. Patent expiry dates for best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars in UK gain NICE recommendation [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 7]. Available from: www.gabionline.net/Policies-Legislation/Biosimilars-in-UK-gain-NICE-recommendation
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of etanercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-etanercept
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