Samsung Bioepis Reports P-I Study Results of SB17, a Proposed Biosimilar to Stelara
- The P-I study evaluating SB17 (45mg) vs Stelara (US & EU sourced) via SC inj. in a ratio (1:1:1) in 201 patients. The primary objective was to demonstrate PK similarity by assessing area under AUCinf and Cmax & secondary objectives was to investigate and compare the safety, tolerability, and immunogenicity b/w three treatment groups
- The study results showed PK equivalence and comparable safety, tolerability, and immunogenicity profiles b/w SB17 and reference ustekinumab. The results will be presented at AAD 2023
- Samsung Bioepis continues to advance its biosimilar portfolio covering immunology, oncology, ophthalmology, hematology, and endocrinology
Ref: Globenewswire | Image: Samsung Bioepis
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