Do Not Fear Biosimilars in Treating IBD

November 21, 2017

Biological treatments are currently the fastest-growing class of therapeutic products in the United States, and the recent emergence of biosimilars has boosted this ever-expanding field of biological products, according to the US Food and Drug Administration (FDA).1

Biosimilars, which can essentially “replace” or “be substituted for” an originator biologic, play an instrumental role in the treatment of inflammatory bowel disease (IBD), said Stephen B. Hanauer, MD, FACG, professor of medicine at Northwestern University Feinberg School of Medicine in Chicago, Illinois. Dr Hanauer is also a chair of Advances in Inflammatory Bowel Diseases (AIBD) 2017 in Orlando, Florida, where he recently presented “Here and Now: Biosimilars for the Treatment of IBD.”2

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Because of biosimilars, patients with IBD have additional and equally effective treatment options, as well as potentially lowered health care costs.1 They can be used to treat both adults and children, as long as the labeling on the originator indicates that it has been approved by the FDA for use in children.

“Do not fear biosimilars,” said Dr Hanauer. “There is increasing data in IBD—in both Crohn disease and ulcerative colitis—regarding the clinical outcomes for patients newly started on infliximab or biosimilar that have either maintained or switched to either the biosimilar or originator. There have been no signals of loss of response or risk from these single switches.”

Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda), which are biosimilars for the biologic Remicade (infliximab), are both FDA-approved and are often recommended for the treatment of IBD, said Dr Hanauer. In addition, 2 more biosimilars for the biologic Humira (adalimumab) have also been approved by the FDA but, due to patent litigation, are not yet marketed in the United States.

However, despite the effectiveness of biosimilars for the treatment of IBD, it remains uncertain whether they will have a strong effect on the future of IBD, according to Dr Hanauer.

“Biosimilars are not going to make much impact on the future of IBD unless more patients will have access to them in earlier disease,” he said. “Currently, there is no indication that this will occur due to FDA’s labeling of originators for the treatment of ‘moderate-to-severe disease.’”

—Christina Vogt


1. Biosimilar and interchangeable products. US Food and Drug Administration. Accessed November 13, 2017.

2. Hanauer SB. Here and now: biosimilars for the treatment of IBD. Presented at: Advances in Inflammatory Bowel Diseases (AIBD) 2017; October 9 to 11, 2017; Orlando, FL.