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Samsung Bioepis’ Remicade biosimilar set for CHMP verdict

Published on 31/03/16 at 04:49pm

Samsung Bioepis has confirmed that the European Commission’s scientific committee, the CHMP, is this week discussing the approval of its Remicade (infliximab) biosimilar.

If green-lighted, Samsung Bioepis’ drug - named Flixabi - would be the second biosimilar version of Janssen and MSD’s original to hit the European market, following Celltrion’s.

It would also be Samsung Bioepis’ second biosimilar to be approved by EU regulators, following its Enbrel (etanercept) copy Benepali earlier this year.

The Korean firm is seeking approval for the Remicade biosimilar in all of the original’s indications: rheumatoid arthritis, adult and paediatric Crohn's disease, ulcerative colitis, paediatric ulcerative colitis, psoriatic arthritis, ankylosing spondylitis and psoriasis.

The European Medicines Agency is expected to reveal the CHMP's decision Friday, and a positive verdict will see the drug go to the European Commission for final approval.

UPDATE, 3/4/16, 16:35: The CHMP has recommended Flixabi for approval in the European Union

Joel Levy

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