Two abstracts for SB 17, a proposed biosimilar to Stelara (ustekinumab), are presented at the 19th Annual Congress of European Crohn’s and Colitis Organisation (ECCO).- Samsung Bioepis + Sandoz
Samsung Bioepis Co., Ltd. announced that two new study results for SB 17( now Pyzchiva), a proposed biosimilar to Stelara (ustekinumab),will be presented at the 19th Congress of European Crohn’s and Colitis Organisation (ECCO) being held from February 21 to 24 in Stockholm, Sweden.
Of the two studies, one study provided an overview of analytical assessment results of SB 17 compared to reference ustekinumab. Overall analytical characterization and similarity assessment results demonstrated SB 17 is highly similar to the Europe and U.S. reference ustekinumab in terms of structural, physicochemical and biological attributes.
In addition, the “totality-of-the evidence” data supported the extrapolation of SB 17 to reference ustekinumab. With biosimilarity in pharmacodynamics, pharmacokinetics (PK) and clinical effect for moderate-to-severe psoriasis (PsO) patients, SB 17 is considered to be highly similar to reference ustekinumab in physicochemical, non-clinical, and clinical studies.
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