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 psoriasis. If approved by the EMA, SB2 is going to be commercialized by Biogen Idec and is expected to become available to treat the same conditions as Remicade.

Samsung is optimistic about the MAA, particularly since they had another biosimilar candidate recently accepted. The EMA had already approved the MAA for SB4, a biosimilar candidate for Enbrel (etanercept), and it is now under regulatory review. The company announced that is now planning on moving forward with other applications regarding regulatory approvals for SB2 in different countries.

In other developments in IBD, a recent study entitled “Infliximab therapy in pediatric patients 7 years of age and younger” reported that treatment infliximab is less efficient in treating IBD in children aged less than 7 years old when compared to its effect in older childrenHospira, Inc. has recently launched the first biosimilar monoclonal antibody (mAb) of Inflectra (infliximab) in the European markets, while the study results used for the approval are going to be presented at the European Crohn’s and Colitis Organisation Inflammatory Bowel Diseases (ECCO-ibd) conference, demonstrating that patients treated with Inflectra have a comparable response to those treated compared to infliximab.