Samsung Bioepis announced their submission to the to the European Medicines Agency (EMA) for SB2, its Remicade (Infliximab) biosimilar candidate. This is the second biosimilar candidate Marketing Authorization Application (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 authorized by the EMA, SB2 will be commercialized in Europe by Biogen Idec.
“If this MAA is approved by EMA, Samsung Bioepis will provide rheumatoid arthritis patients inEurope with an important new treatment option,” said Christopher Hansung Ko, chief executive officer of Samsung Bioepis.
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, established in 2012 as part of the Samsung group, intends to move forward with additional applications for regulatory approvals in other territories around the globe.