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FDA review: Remicade biosimilar extrapolation "reasonable"

February 6, 2016 1:10 AM UTC

On Friday, FDA posted Celltrion Inc. (KOSDAQ:068270) for its CT-P13, a biosimilar of Remicade infliximab from Johnson & Johnson (NYSE:JNJ).

Celltrion conducted clinical studies of CT-P13 in rheumatoid arthritis and ankylosing spondylitis, and is seeking extrapolation of CT-P13 across all seven of Remicade's approved indications including Crohn's disease, pediatric Crohn's disease, ulcerative colitis (UC), pediatric UC, psoriatic arthritis and plaque psoriasis. ...