On June 22, 2017, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicine’s Agency (“EMA”) recommended Samsung Bioepis’ Imraldi® (SB-5, adalimumab), a biosimilar to AbbVie’s Humira®, for approval.  The CHMP’s recommendation will be referred to the European Commission for final marketing authorization.

Adalimumab is a TNF (tumor necrosis factor) inhibitor that binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors. Samsung Bioepis is seeking approval of Imraldi® for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, and uveitis.

Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen.  The company announced that its application for adalimumab was accepted by the EMA in July 2016, and it also has an application pending for adalimumab in Korea.  The company prevailed in patent litigation in the UK involving two patents related to adalimumab earlier this year, as we previously reported here.  According to Biogen, “global sales estimates for Humira® stand at $16 billion in 2017, making it the number-one prescribed biologic therapy in the world.”