Samsung Bioepis Reports P-IV Study of SB4 (biosimilar, etanercept)
- The first P-IV postmarketing surveillance study evaluates SB4 (qw, SC) in 316 patients with axSpA, RA, PsA, and PsO in Korea. Both etanercept-naïve patients or patients switched from reference etanercept
- The results showed comparable effectiveness & safety to historical SB4 real-world evidence without any new significant safety signals, AEs were reported in 17.8% of patients, ADRs (9.9%), serious AEs (1.3%), and most AEs were mild or mod. (66.7% & 31.1%, respectively) & unrelated to SB4 (58.9%)
- Additionally, mean disease activity scores were significantly lower over baseline in etanercept-naïve patients with AS & RA (2.7 vs 6.2); in switched patients (1.0 vs 1.3) @24wks. The study had a high retention rate similar to a previous study
Ref: Centre for Biosimilars | Image: Samsung Bioepis
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