Samsung Bioepis updates on biosimilars of Stelara and Keytruda

South Korean biosimilars company Samsung Bioepis today announced that  two new study results for SB17, a proposed biosimilar to Stelara (ustekinumab), marketed by Johnson & Johnson (NYSE: JNJ), will be presented at the 19th Congress of European Crohn’s and Colitis Organization (ECCO) being held from February 21 to 24 in Stockholm, Sweden.

Of the two studies, one provided an overview of analytical assessment results of SB17 compared to reference ustekinumab. Overall analytical characterization and similarity assessment results demonstrated SB17 is highly similar to the Europe and USA reference ustekinumab in terms of structural, physicochemical and biological attributes.

In addition, the “totality-of-the evidence” data supported the extrapolation of SB17 to reference ustekinumab. With biosimilarity in pharmacodynamics (PD), pharmacokinetics (PK) and clinical effect for moderate-to-severe psoriasis (PsO) patients, SB17 is considered to be highly similar to reference ustekinumab in physicochemical, non-clinical, and clinical studies.