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CADTH summarizes evidence on switching to etanercept biosimilars Posted 23/04/2021

The Canadian Coordinating Office for Health Technology Assessment (CCOHTA), known today as CADTH, is an independent, not-for-profit organization responsible for providing Canada’s healthcare decision-makers with objective evidence to help make informed decisions about the optimal use of drugs and medical devices in our healthcare system.

CADTH published its reference list and summary for ‘Switching from reference to biosimilar etanercept for patients with plaque psoriasis’ in February 2021 [1].

The research question addressed was ‘What is the clinical effectiveness of switching from reference to biosimilar etanercept in adult or paediatric patients with plaque psoriasis?

In order to address this question CADTH carried out a literature search of MEDLINE, Embase, the Cochrane Database of Systematic Reviews, the international HTA database, the websites of Canadian and major international health technology agencies, as well as a focused Internet search. The main search terms were etanercept and plaque psoriasis and results were limited to humans and English language documents published between 1 January 2016 and 2 February 2021.

Two randomized controlled trials were identified regarding the clinical effectiveness of switching from reference to biosimilar etanercept in adult or paediatric patients with plaque psoriasis.

The two trials analysed data from the EGALITY study. Patients were randomly assigned to self-administer reference etanercept or biosimilar etanercept, and those that had at least a 50% improvement based on the Psoriasis Area and Severity Index (PASI 50) at Week 12 were re-randomized to either continue using their initially assigned treatment, or to undergo three consecutive treatment switches until Week 30. Following this, all patients remained on the last assigned treatment until Week 52. Patients initially assigned to reference etanercept and patients assigned to biosimilar etanercept did not differ significantly in response rate at Week 12 [3]. Patients who switched treatments and patients who continued with the same treatment had similar treatment responses up to Week 30 as measured by PASI 50, PASI 75, and PASI 90 response rates and per cent change from baseline in PASI scores [2]. Incidence of treatment-emergent adverse events was also comparable across groups up to Week 30 [2] and Week 52 [3]. No patients tested positive for binding anti-drug antibodies [2].

The EGALITY study was a phase III, randomized, double-blind, multicentre study carried out by Sandoz (the generics division of Novartis) on its biosimilar etanercept candidate (GP2015) [4]. Sandoz received approval for Erelzi (GP2015) in the US in August 2016 [5], in Europe in June 2017 [6], in Canada in August 2017 [7] and in Australia in November 2017 [8].

Other real-world data from studies carried out across Europe on switching to etanercept biosimilars showed no significant differences in patients that switched or remained on originator etanercept in terms of efficacy [9].

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References
1. Vu T, Argáez C. CADTH reference list switching from reference to biosimilar etanercept for patients with plaque psoriasis. February 2021.
2. Gerdes S, Thaci D, Griffiths CEM, et al. Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study. J Eur Acad Dermatol Venereol. 2018;32(3):420-7.
3. Griffiths CEM, Thaci D, Gerdes S, et al. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol. 2017;176(4):928-38.
4. GaBI Online - Generics and Biosimilars Initiative. Sandoz advances biosimilars pipeline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-advances-biosimilars-pipeline 
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US 
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada 
8. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23] Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia 
9. GaBI Online - Generics and Biosimilars Initiative. Real-world data on switching of etanercept biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Biosimilars/Research/Real-world-data-on-switching-of-etanercept-biosimilars

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Source: CADTH

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