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Samsung Bioepis submits marketing authorization application for Remicade biosimilar
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Samsung Bioepis announced it has submitted a marketing authorization application to the European Medicines Agency for a second biosimilar drug, dubbed SB2, to treat rheumatoid arthritis.
The submission for the Remicade (infliximab, Janssen) biosimilar is based on results from preclinical data comparing the biosimilar with infliximab, a phase 1 head-to-head comparison of the two treatments in healthy volunteers, and a phase 3 head-to-head comparison in patients with moderate-to-severe rheumatoid arthritis (RA), according to a company press release.
"If this MAA is approved by EMA, Samsung Bioepis will provide rheumatoid arthritis patients in Europe with an important new treatment option," Christopher Hansung Ko, CEO of Samsung Bioepis, said in the release.
In Europe, infliximab is approved to treat RA, pediatric and adult Crohn's disease, ulcerative colitis, psoriasis, psoriatic arthritis and ankylosing spondylitis.
The company's biosimilar for Enbrel (etanercept, Amgen), SB4, which is approved to treat a similar range of diseases, was submitted to the European Medicines Agency earlier this year. Hospira submitted the first infliximab biosimilar to the agency last month.
In the U.S., a meeting of the arthritis advisory committee was scheduled for today but earlier postponed. A new meeting date has not yet been announced. Earlier this month, the FDA approved the first biosimilar, Zarxio (filgrastim-sndz, Sandoz), which is biosimilar to Neupogen (filgrastim, Amgen).
Referenc e: www.samsungbioepis.com.