Samsung Submits MAA for Remicade Biosimilar For Crohn’s Disease, Ulcerative Colitis to EMA

Samsung Submits MAA for Remicade Biosimilar For Crohn’s Disease, Ulcerative Colitis to EMA
Samsung BioepisSamsung Bioepis Co. Ltd. recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) regarding a biosimilar treatment for several conditions, including Crohn's disease and ulcerative colitis. The Remicade (Infliximab) biosimilar candidate, called SB2, is now the second biosimilar candidate by Samsung Bioepis to file for an MAA from the EMA. Samsung filed the application based on the outcomes from a large head-to-head preclinical data package focused on both SB2 and the original drug, which was compared in a phase I study that also included healthy participants. In addition, the company also presented data from a head-to-head phase III equivalence trial, which examined patients who suffer from moderate-to-severe rheumatoid arthritis (RA), one of the conditions for which the drug is indicated. Remicade is indicated in Europe to treat adults and children with Crohn's disease, adults and children with ulcerative colitis, which are the two main types of inflammatory bowel diseases (IBD), as well as rheumatic arthritis, psoriatic arthritis, ankylosing spondylitis and ps
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