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FDA Arthritis Advisory Committee votes in favor of biosimilar to infliximab

February 9, 2016

Members of the FDA Arthritis Advisory Committee voted positively today for the recommendation to approve the biologics license application of Celltrion’s CT-P13 biosimilar to infliximab. If approved, CT-P13 would be the first biosimilar monoclonal antibody to be approved for use in the United States.

In a 21-to-3 vote, the committee recommended CT-P13 should receive licensure as a biosimilar product for the indications for which the originator infliximab (Remicade, Janssen Biotech) is currently licensed in the United States and also be eligible for licensure for treatment of rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, adult and pediatric Crohn’s disease and adult ulcerative colitis.

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The Patient with Dry Eyes and Dry Mouth

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LASIK for Hyperopia Using an Aberration-Neutral Profile With an Asymmetric Offset Centration

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