Switching patients with Crohn disease from reference adalimumab to SB5, a Samsung Bioepis biosimilar, did not lead to major changes in disease activity in a real-world analysis.
Patients with Crohn disease who were switched from reference adalimumab (Humira; AbbVie) to Samsung Bioepis’ adalimumab biosimilar (SB5) did not experience any major differences in disease activity, suggesting that switching to a biosimilar was safe and tolerable.
The results were part of the PROPER study, an interim analysis assessing real-world use of SB5 after transition from the reference product in a Crohn disease-specific population, and were presented during the European Crohn’s and Colitis Organization’s 2022 annual meeting, the company said in a statement to The Center for Biosimilars®.
SB5 received marketing authorization in the European Union, where it is marketed under the name Imraldi, in August 2017. It was also approved by the FDA in July 2019 under the name Hadlima, where it will be marketed through a commercialization agreement between Republic of Korea–based Samsung Bioepis and Organon, a Merck spin-off company based in New Jersey. In January 2022, the 2 companies announced that they would pursue regulatory approval for a high-concentration, citrate-free formulation of Hadlima.
Although the original SB5 formulation has been on the market in Europe since receiving authorization, it is not permitted for US market introduction until 2023, the year when adalimumab biosimilars will legally be allowed on the market. There are 9 authorized adalimumab biosimilars in the European Union and 7 FDA-approved products in the United States.
The approvals were based on preclinical and clinical phase 1 and phase 3 studies that demonstrated that the biosimilar had comparable safety, efficacy, immunogenicity, and pharmacokinetic profiles to the reference product.
The PROPER study included patients with immune-mediated inflammatory disease who were receiving treatment at 32 specialty centers in Belgium, Germany, Ireland, Italy, Spain, and the United Kingdom. Eligible patients were transitioned to SB5 following a minimum of 16 weeks of treatment with Humira. The data were retrospectively collected from patient charts from 24 weeks prior to 48 weeks after the initiation of treatment with SB5. The data extract date was October 5, 2021.
In total, 462 patients were enrolled in the analysis, with a mean (SD) age of 43.5 (14.0) years, and 46% were women. The majority of the cohort was from Germany (n = 127), followed by Spain (n = 118), Italy (n = 79), Belgium (n = 56), Ireland (n = 46), and the United Kingdom (n = 36). At the time of data collection, 416 patients had completed 48 weeks of follow-up and 15 patients withdrew from the study.
The most common reasons that patients switched away from the reference product were physician decision and a mandate from a health authority or payer. At baseline, most of the patients were in remission or had mild disease but were considered to be in remission or have a stable condition according to a physician.
Overall, in 24 patients, 27 serious adverse events were reported, of which 4 were considered to be related to the SB5 therapy. Treatment-related events included 1 case of anal fistula, 2 cases of perianal abscesses, and 1 case of subileus. The investigators determined that no new safety concerns were detected.
Dignass AU, Gisbert JP, Bossa F, Freudensprung U, Addison J. The PROPER study: interim analysis of a Pan-European real-world study of SB5 adalimumab biosimilar after transition from reference adalimumab in patients with Crohn’s disease. Presented at: ECCO 2022; February 16-19, 2022; Virtual. Abstract P434.