Samsung Bioepis Receives EU Marketing Authorization for Adalimumab Biosimilar

Yesterday, Biogen announced that the European Commission has granted marketing authorization for Imraldi® (also known as SB5). Imraldi® is a biosimilar for Humira® (adalimumab).  Imraldi® 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.  Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen.  This marks the second biosimilar to Humira® to receive marketing authorization in the EU, following Amgen’s approval for their biosimilar earlier this year.