Samsung Bioepis + Biogen file SB 2 infliximab biosimilar at EMA.

Samsung Bioepis Co., Ltd., announced that the Marketing Authorization Application (MAA) for SB 2, its Remicade (infliximab) biosimilar candidate, has been submitted to the European Medicines Agency (EMA). This is the second biosimilar candidate MAA that Samsung Bioepis has submitted to the EMA which was SB 4, an etanercept biosimilar.

The MAA is based on results from an extensive head-to-head preclinical data package comparing SB2 to the originator, a head-to-head Phase I study in healthy volunteers, and a robust head-to-head Phase III equivalence trial in patients with moderate-to-severe rheumatoid arthritis (RA). In Europe, Remicade is indicated for the treatment of rheumatic arthritis, adult Crohn's disease, pediatric Crohn's disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis, ankylosing spondylitis and psoriasis. If authorized by the EMA, SB2 could be available for use in all of the same indications as Remicade.