The European Commission (EC) granted a marketing authorization for IMRALDI® (also known as SB5), an adalimumab biosimilar referencing Humira®.
IMRALDI has been developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen and is approved for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis.
EU Biosimilar anti-TNF biosimilar approval by Biogen:
2016 > BENEPALI® (etanercept), a biosimilar referencing Enbrel®
2016 > FLIXABI® (infliximab), a biosimilar referencing Remicade®
2017 > IMRALDI® (also known as SB5), an adalimumab biosimilar referencing Humira®
Clinical Trial for IMRALDI approval:
- The EC approval was based on a robust preclinical and clinical data package comparing IMRALDI 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 Humira7 and a 52 week Phase III, randomized, double-blind, multicenter study, in which IMRALDI demonstrated comparable efficacy and comparable safety and immunogenicity to Humira in patients with moderate to severe RA despite methotrexate therapy.
- The primary endpoint of the Phase III study, the American College of Rheumatology 20% (ACR20) response at Week 24, was met, demonstrating equivalent efficacy to Humira (ACR20 response rate was 72.5% in the IMRALDI group versus 72.0% in the Humira group).8 Between Week 24 and Week 52, in 125 patients who were switched from Humira to IMRALDI, efficacy, safety, and immunogenicity profiles were found to be comparable to those in patients who remained on Humira (129) or IMRALDI (254) during the transition period.