Biosimilarity of BAT2206 and its originator ustekinumab (European Union or USA licensed) in pharmacokinetic profiles, safety, and immunogenicity was evaluated.

Pharmacokinetic similarity between BAT2206 and ustekinumab (USA or European Union sourced) was confirmed.

The incidence of anti-drug antibodies in the BAT2206 group was higher than those in the other two groups, whereas the incidences of positive neutralizing antibodies were similar among the three groups.

The three groups had similar safety profiles and the investigational drugs were well tolerated by subjects.