Samsung Bioepis' Etanercept Biosimilar Performs in Real-World Treatment of Psoriasis

In treating patients with moderate to severe psoriasis, Samsung Bioepis’ etanercept biosimilar, approved in the European Union as Benepali and in the United States as Eticovo, was shown to be effective in a registry study.

The British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR), an observational study in the United Kingdom and Ireland, assesses the long-term safety of biologic therapies for psoriasis. More than 160 hospital sites across the region, and more than 18,000 patients with an excess of 110,000 follow-ups, are taking part in the study.

The current study of the biosimilar, which references Enbrel, includes 269 patients enrolled in BADBIR who were treated with the product between 2016 and 2018. In total, clinical data were available for 189 of the biosimilar-treated patients.¹

At baseline, patients had a mean disease duration of 22.6 years, and their 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%.

In total, 48 patients had PASI scores available at baseline and at 6 months of treatment; in the 20 patients whose baseline PASI scores were below 10, PASI score did not increase after 6 months. The mean PASI score at baseline (3.2) was unchanged at 6 months. Among the 28 patients who had baseline PASI scores of 10 or higher (mean, 15.7), PASI was reduced at 6 months to a mean score of 5.0.

According to Seongwon Han, MD, vice president and lead of medical team, Samsung Bioepis, these results show that the biosimilar is effective when used by patients in a real-world setting. “We hope the growing wealth of real-world data on Benepali will help physicians make informed decisions when treating patients with biosimilars,” Han said in a statement.

Results from the BADBIR study will be presented on October 10 during an oral free communication session at the European Academy of Dermatology and Venereology Congress, held this week in Madrid, Spain.

European evidence underscoring the efficacy of the biosimilar etanercept continues to grow; earlier this year, a systematic review reported on real-world evidence on the use of the biosimilar in treating inflammatory diseases, and it found that rates of clinical remission in patients with psoriatic arthritis and psoriasis did not change after patients switched from the reference product to the biosimilar, and that the risk of serious adverse events was similar between patients who started treatment with the biosimilar versus those who switched.²

Despite the fact that the biosimilar has become a mainstay of therapy in the European Union—Samsung Bioepis says that, based on IQVIA data, Benepali is the most prescribed etanercept across France, Germany, Italy, Spain, and the United Kingdom combined—US patients continue to wait for a biosimilar etanercept option to reach the market, and that wait could be a lengthy one.

In August of 2019, a long-anticipated court decision in a case over etanercept patents, involving Enbrel’s sponsor, Amgen, and a different biosimilar developer, Sandoz, found that the biosimilar’s sponsor failed to show that Amgen’s patents on etanercept were invalid. While Sandoz is appealing the decision in that case, patent protection for the reference product could potentially extend in the US context until 2029.

Reference

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). Presented at: the European Academy of Dermatology and Venereology Congress; October 9-13, 2019; Madrid, Spain.

2. Ebbers HC, Pieper B, Issa A, Addison J, Freudensprung U, Rezk MF. Real-world evidence on etanercept biosimilar SB4 in etanercept-naïve or switching patients: a systematic review [published online August 5, 2019]. Rheumatol Ther. doi: 10.1007/s40744-019-00169-4.