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news.Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval for its Remicade (Infliximab) biosimilar candidate, SB2.
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The application is based on data from an extensive head-to-head preclinical data package comparing SB2 to the originator, a head-to-head Phase I trial in healthy volunteers, and a head-to-head Phase III equivalence trial in patients with moderate-to-severe rheumatoid arthritis (RA).
According to the company, this is the second biosimilar candidate MAA that has been submitted to the EMA.
In Europe, Remicade is used to treat rheumatic arthritis, adult Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis, ankylosing spondylitis and psoriasis.
Samsung Bioepis chief executive officer Christopher Hansung Ko said: "If this MAA is approved by EMA, Samsung Bioepis will provide rheumatoid arthritis patients in Europe with an important new treatment option."
If approved, SB2 could be available for use in all of the same indications as Remicade and will be commercialised by Biogen Idec in Europe.
Earlier, the company had reported that the EMA had accepted an MAA for SB4, its Enbrel (etanercept) biosimilar candidate, which is currently under regulatory review.
Currently, the company plans to move forward with additional applications for regulatory approvals in other territories around the globe.