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

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

A recent FDA meeting considered a biosimilar treatment for Crohn’s disease and ulcerative colitis.

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 the testimony of the chief scientific officer of the Crohn’s & Colitis Foundation of America (CCFA), a CCFA volunteer, and a CD patient’s mother.

Biosimilars, as defined by the FDA, are biological products whose approval relies on the proven high similarity to an FDA-approved biological reference product, with no significant clinical differences in terms of safety and effectiveness. Clinically inactive components of the product are allowed minor differences from the reference product.

Celltrion aims to obtain approval for CT-P13 in all the disease indications of the reference product infliximab, approved by the FDA in 1999. Besides UC and Crohn’s disease, infliximab is also used to treat rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis.

Dr. Caren Heller, CSO of the Crohn’s & Colitis Foundation of America, stated that the CCFA, the leading nonprofit organization funding IBD research and providing support for patients and families, supports the innovation and all FDA-approved therapies for patients suffering from debilitating IBD conditions. Heller said biosimilars can create competition in the market and cost savings for the healthcare system, which the foundation hopes will translate in cost-savings for patients and their families who face great financial burden.

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