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 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.

“We urge the FDA to support access to biosimilars while also ensuring that they will not cause immunogenicity or loss of response. We also encourage the FDA to partner with stakeholder organizations to educate patients and physicians about this new class of biologic drugs,” Heller said in a press release.

CCFA published its full comments on the subject, highlighting key safety points regarding the need for human testing of biosimilar products to ensure patient safety, the need for patient and provider education to raise awareness and knowledge about biosimilar products, and hard proof of interchangeability between the reference product and the biosimilar.

Cindi Becker, a CCFA volunteer and the mother of a Crohn’s patient, also provided valuable testimony about patients’ and families’ perspectives on biosimilar products, especially regarding the need for more affordable care.

“Crohn’s disease and ulcerative colitis are complicated, expensive diseases. Most patients max out their deductibles on their health insurance because of costly medications, doctor’s appointments, and procedures,” Becker said. “This financial difficulty comes on top of the physical pain and stress that these incurable digestive diseases cause. Please do your part to ensure that drugs that can help us are safe and are reaching the market to help alleviate some of the burden felt by patients and their loved ones.”