FDA Holds Meeting On Application For First Biosimilar For Use With Crohn’s & Colitis Patients

NEW YORK, Feb. 9, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration convened a meeting of its Arthritis Advisory Committee today to review biologics license application (BLA) 125544, for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by Celltrion, Inc. The Crohn's & Colitis Foundation of America (CCFA), the leading non-profit organization funding inflammatory bowel disease (IBD) research and providing patient support programs, testified at the meeting to discuss the implications of biosimilar use among IBD patients and the hopes and safety concerns of the Crohn's disease and ulcerative colitis community in the development of these new medications.

"CCFA supports innovation and welcomes all FDA-approved therapies for inflammatory bowel disease patients," said Dr. Caren Heller, CCFA's Chief Scientific Officer. "Biosimilars pose both an opportunity to increase competition in the marketplace and a risk to patient safety if not properly utilized. If the introduction of biosimilars creates cost-savings in the healthcare system, our hope is that the majority of that cost savings will be passed along to our patients."

According to the FDA, a biosimilar is a biological product that is highly similar to an FDA-approved biological product and has no clinically meaningful differences from the originator in terms of safety and effectiveness.

"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," said Dr. Heller.

Cindi Becker, a volunteer with CCFA whose daughter has Crohn's disease, also testified at the meeting to provide the patient perspective on biosimilars.

"If there's a medication that can help patients with IBD, like a biosimilar, we need it. We need drugs that are new, more affordable and more obtainable to families. We need to be secure in their safety - that they won't harm ourselves or our loved ones," said Becker. "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. 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."

Infliximab was approved by the FDA in 1999 and is used to treat a variety of inflammatory conditions, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and Ankylosing Spondylitis. Celltrion is seeking approval for all disease indications for their biosimilar.

Below are some key safety points from CCFA's written comments:

• Immunogenicity and patient safety: CCFA urges that all biologics and biosimilars undergo thorough human testing and meet the highest safety standards. Consideration should be given to the application of the biosimilar in pediatric patients.
• Patient and Provider Education: The FDA should partner with stakeholder organizations to educate patients and providers about biosimilars. CCFA is concerned about the lack of awareness and understanding about biosimilars among both of these groups. Misunderstanding could lead to misuse, and in the worst circumstances, malpractice.
• Interchangeability: When considering interchangeability with the biosimilar, provide reasonable proof that switching from the originator to the biosimilar would not incur immunogenicity or loss of response to the originator (and vice versa). This is of particular importance, given the risk of loss of response to therapy and the risk of infusion or injection reactions that may occur due to immunogenicity or allergic reactions.

CCFA's full comments can be viewed here.

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SOURCE Crohn's & Colitis Foundation of America