Samsung Bioepis Reports P-IV Study of SB4 (biosimilar, etanercept)

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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 

Related Post:- Samsung Bioepis and Organon’s Hadlima (biosimilar, adalimumab) Receive Health Canada’s Approval

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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