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Positive real-world data for etanercept biosimilar Benepali Posted 25/10/2019


Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 9 October 2019 that it had presented positive real-world data from its etanercept biosimilar Benepali at the 2019 European Academy of Dermatology and Venereology (EADV) Congress [1].

Benepali was approved in the European Union in January 2016 for the treatment of patients with axial spondyloarthritis, psoriatic arthritis, plaque psoriasis and rheumatoid arthritis [2].

The real-world data for Benepali (SB4) came from a study of patients with moderate to severe psoriasis from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR).

BADBIR is a UK and Ireland observational study that assesses the long-term safety of biological treatments for psoriasis. Samsung Bioepis has been participating in this study since May 2016. The study included BADBIR-registered patients treated with Benepali from 1 January 2016 to 1 September 2018. From the 269 patients who received Benepali, clinical data for 189 patients was available and was included in the analysis.

At baseline enrolment, the mean disease duration was 22.6 years and the mean Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores were 11.6 and 13.1, respectively. The median treatment period was 14.1 months and the discontinuation rate was 26.3%. Of the 48 patients who had their PASI score available both at baseline and at six months, disease activity of 20 patients with baseline PASI < 10 (mean PASI 3.2) did not increase after six months (mean PASI 3.2). Disease activity of 28 patients with baseline PASI ≥ 10 (mean PASI 15.7) was reduced after six months (mean PASI 5.0).

Seongwon Han, MD, Vice President and lead of the medical team said that the ‘results from this study show that Benepali was effective when used by patients in the real-life setting’. He added that ‘we hope the growing wealth of real-world data on Benepali will help physicians make informed decisions when treating patients with biosimilars’.

These results were presented at the 2019 European Academy of Dermatology and Venereology (EADV) Congress, which took place on 9‒13 October 2019 in Madrid, Spain.

Editor’s comment
It should be noted that data of the study presented in this article [1] was presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.

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1. Egeberg, et al. Real world data of SB4 (etanercept biosimilar) in patients with psoriasis from the British Association of Dermatologists Biologic Interventions Register (BADBIR). EADV 2019; 9-13 October 2019; Madrid, Spain.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: EADV, Samsung Bioepis

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