Safety and Effectiveness of Etanercept Biosimilar SB4 for Rheumatic Diseases in South Korea: Real-World Post-marketing Surveillance Data

Yoo, Wan‐Hee; Kang, Young Mo; Kim, Dong Wook; Kang, Eun Ha; Lee, Yeon-Ah; Suh, Chang‐Hee; Sung, Yoon‐Kyoung; Lee, Sanghoon; Gu, Dong-Ha; Lee, Jiwon; Choe, Jung‐Yoon

doi:10.1007/s40744-022-00515-z

Cited by 3 publications

(1 citation statement)

References 22 publications

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“…Several observational studies assessed the effectiveness of biosimilar products in these remaining indications and showed that there was no difference between originator and biosimilar products. However, they were often small, 4 5 non-comparative [6][7][8] or pathology-specific, [9][10][11][12] as we already did for inflammatory bowel diseases using the same database from 2015 to 2017. 13 14 In Europe, four IFX, four ETA and 12 ADA biosimilars have been approved from 2015, 2016 and 2018, respectively, 15 based on bioequivalence data demonstrated in 1-3 indications.…”

Section: What This Study Addsmentioning

confidence: 99%

Persistence and safety of anti-TNF biosimilars versus originators in immune-mediated inflammatory diseases: an observational study on the French National Health Data System

Jourdain,

Hoisnard,

Sbidian

et al. 2024

RMD Open

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ObjectivesBiosimilar-originator equivalence has been demonstrated in phase 3 trials in a few indications of infliximab, etanercept and adalimumab. The objective of our study was to compare the persistence and safety of biosimilars versus originators in all the licensed indications of these molecules.MethodsWe used data from the French National Health Data System (SNDS), covering 99% of the French population, to identify infliximab, etanercept and adalimumab initiators from biosimilar launch (January 2015, May 2016 and October 2018, respectively) to 30 June 2021. Patients were then followed for 1 year. Treatment persistence (duration without treatment discontinuation or modification) and safety (including severe infections, all-cause hospitalisation and death) were compared between originator and biosimilar users by Cox regressions weighting the populations on the inverse probability of treatment. Analyses were performed by molecule, by disease and by biosimilar product.ResultsFrom January 2015 to June 2021, 86 776 patients were included in the study: 22 670, 24 442 and 39 664 patients had initiated infliximab, etanercept and adalimumab, respectively; 49 752 (53%) were biosimilar initiators. We did not find any risk of discontinuation (HRs were below or around 1, here all pathologies and products together: infliximab 0.88 (0.80–0.97), etanercept 0.85 (0.81–0.90) and adalimumab 0.96 (0.91–1.00)) or safety event (infection: infliximab 0.97 (0.78–1.21), etanercept 1.04 (0.81–1.33) and adalimumab 0.98 (0.83–1.16); hospitalisation: infliximab 1.08 (0.96–1.23), etanercept 0.99 (0.87–1.11) and adalimumab 0.91 (0.83–0.99)) associated with biosimilar versus originator use.ConclusionsOur study shows reassuring results regarding the persistence and safety of biosimilar tumour necrosis factor-alpha inhibitors compared with originators in all licensed indications.

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Section: What This Study Addsmentioning

confidence: 99%

Persistence and safety of anti-TNF biosimilars versus originators in immune-mediated inflammatory diseases: an observational study on the French National Health Data System

Jourdain,

Hoisnard,

Sbidian

et al. 2024

RMD Open

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Etanercept

2023

Reactions Weekly

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Incidence of serious infection among etanercept and infliximab initiators: safety comparison between biosimilars and bio-originators with Canadian population-based data

Birck,

Lukusa,

Choquette

et al. 2024

BMC Rheumatol

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Background Safety remains a significant concern for biologic drugs, and studies are needed to ensure a comparable safety profile for biosimilars and their legacy treatments. Using Canadian administrative health data from 2015–2019, we compared the incidence of serious infection between biosimilars and bio-originators initiators for etanercept and infliximab, two of the most commonly used biologics during this time. Methods We performed a retrospective cohort study using pan-Canadian data (except Quebec) from the National Prescription Drug Utilization Information System linked to hospitalization data. We studied new users of infliximab or etanercept (January/2015-December/2019) and compared incidence rates of serious infection, defined as those which required hospitalization, by using Cox regression models adjusted by biological sex, age at treatment initiation, prior corticosteroid or biologic, province, and calendar year. Results We studied 6,583 etanercept users (mean age 62) and 7,202 infliximab users (mean age 45). Hospitalization with infections occurred in 7% of infliximab and 2% of etanercept users. Comparing the risk of infection between biosimilar to bio-originator, the adjusted hazard ratio (95% confidence interval) was 1.33 (0.77, 2.30) for etanercept and 0.93 (0.72, 1.18) for infliximab. Conclusions Our study found no clear difference between etanercept and infliximab biosimilars and their bio-originators for infection incidence, suggesting a similar safety profile. Supplementary Information The online version contains supplementary material available at 10.1186/s41927-024-00415-5.

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Safety and Effectiveness of Etanercept Biosimilar SB4 for Rheumatic Diseases in South Korea: Real-World Post-marketing Surveillance Data

Cited by 3 publications

References 22 publications

Persistence and safety of anti-TNF biosimilars versus originators in immune-mediated inflammatory diseases: an observational study on the French National Health Data System

Persistence and safety of anti-TNF biosimilars versus originators in immune-mediated inflammatory diseases: an observational study on the French National Health Data System

Etanercept

Incidence of serious infection among etanercept and infliximab initiators: safety comparison between biosimilars and bio-originators with Canadian population-based data

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