First Biosimilar Therapy for Crohn’s Disease and Ulcerative Colitis Is Focus of FDA Meeting

First Biosimilar Therapy for Crohn’s Disease and Ulcerative Colitis Is Focus of FDA Meeting
The U.S. Food and Drug Administration (FDA) Arthritis Advisory Committee recently met to review a biologics license application (BLA) submitted by Celltrion Inc. for its compound CT-P13, a proposed biosimilar to Remicade (infliximab, Janssen Biotech), a medicine used to treat a variety of inflammatory diseases including Crohn’s disease (CD) and ulcerative colitis (UC). The meeting also included

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