INCHEON, Republic of Korea, March 13, 2015 - Samsung Bioepis Co., Ltd., today announced that the Marketing Authorization Application (MAA) for SB2, 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.
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.
"If this MAA is approved by EMA, Samsung Bioepis will provide rheumatoid arthritis patients in Europe with an important new treatment option," said Christopher Hansung Ko, chief executive officer of Samsung Bioepis. If authorized by the EMA, SB2 will be commercialized in Europe by Biogen Idec.
In addition to the European filing for SB2, Samsung Bioepis previously announced that the EMA had accepted an MAA for SB4, its Enbrel (etanercept) biosimilar candidate, which is currently under regulatory review. The company intends to move forward with additional applications for regulatory approvals in other territories around the globe.
Samsung Bioepis previously conducted SB2 Phase I and Phase III clinical studies. The MAA for the infliximab biosimilar candidate was based on data from a Phase III, controlled, randomized, multicenter study in Europe where SB2 demonstrated its comparability to Remicade. The primary and secondary endpoints of the Phase III study were assessed and met the qualification standard for the MAA submission. Full data from the study will be available later this year.
The company was established in 2012 as part of the Samsung group, and is a joint venture between Samsung Biologics and Biogen Idec. The company’s mission is to produce affordable, high-quality biopharmaceutical products to many patients in need. The company aims to be the world leading biopharmaceutical company with its heritage of innovation and advanced technologies. Please visit www.samsungbioepis.com for more information.