Samsung Bioepis Co., Ltd., has recently announced its submission to the European Medicines Agency (EMA) concerning the Marketing Authorization Application (MAA) for SB2, a biosimilar candidate for Remicade (Infliximab). This is the second MAA for biosimilar candidates that Samsung Bioepis has submitted to the EMA that could represent a major advance in addressing rheumatoid arthritis (RA).
The MAA makes the case for approval of SB2 by presenting the outcomes of a comprehensive head-to-head pre-clinical data collection that compared SB2 with Remicade in a head-to-head Phase I study that assessed healthy volunteers, as well as a strong and consistent head-to-head Phase III trial in assessing patients suffering with moderate-to-severe types of RA.
In Europe, Remicade is prescribed as treatment for RA, pediatric Crohn’s disease, adult Crohn’s disease, pediatric ulcerative colitis, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. If the EMA authorizes the utilization of SB2, it could address the same diseases that the origin drug Remicade is indicated for.
Christopher Hansung Ko, Samsung Bioepis’ CEO, said in a press release: “If this MAA is approved by EMA, Samsung Bioepis will provide rheumatoid arthritis patients in Europe with an important new treatment option.” If the authorization is granted by the EMA, SB2 will be marketed by Biogen Idec in Europe.
In addition to the European filing for SB2, Samsung Bioepis previously announced that the EMA granted an MAA for SB4, the biosimilar candidate Enbrel (etanercept), which is now being reviewed for regulatory purposes. The company aims to advance more applications to obtain biosimilar regulatory approvals for other regions around the world.
