Additional Relevant Details The MAA is based on a robust preclinical and clinical data package comparing SB5 with Humira. The clinical data include results from two head-to-head studies – a Phase I study in healthy volunteers that demonstrated pharmacokinetic bioequivalence to Humira and a Phase III, randomized, double-blind, multicenter study, in which SB5 demonstrated comparable efficacy, safety, and immunogenicity to Humira in patients with RA. The primary endpoint of the Phase III study, the ACR20 score response at Week 24, was met, demonstrating equivalent efficacy to Humira. Secondary endpoints demonstrated that SB5 has a comparable safety and immunogenicity profile to Humira.