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Biosimilar Infliximab Deemed Safe, Effective in Pediatric Patients With IBD


Researchers found that an infliximab biosimilar was as safe and effective as the reference product (Remicade) in pediatric patients with inflammatory bowel disease. However, more studies on adalimumab biosimilars in pediatric patients are needed.

According to a review published in Biologics, studies confirmed that the infliximab biosimilar CT-P13 (Inflectra, Remsima) is as safe and effective as the reference product (Remicade) in both treatment-naïve pediatric patients and those switching from the originator. However, more research is necessary on the use of adalimumab biosimilars and on multiple switches between infliximab biosimilars in pediatric populations, according to a review article on the use of biosimilars in pediatric inflammatory bowel disease (IBD).

IBD includes Crohns disease (CD) and ulcerative colitis (UC), relapsing and remitting inflammatory diseases of the gastrointestinal tract. The introduction of biologics inhibiting tumor necrosis factor alpha (TNF-α) “has significantly changed the management and outcome of [patients with IBD] and has become a core component of the pharmacological treatment for these diseases,” the reviewers said.

Infliximab and adalimumab, another monoclonal antibody to TNF-α, are available for treating pediatric patients with IBD. The first biologic approved for treating IBD was infliximab in 1998, whose patent expired in 2013. There are currently 4 biosimilars authorized by the European Medicines Agency referencing Remicade and 10 for reference adalimumab (Humira).

Approaches to Biosimilar Use in Pediatric IBD

Anti-TNF biologics are typically used in a “step-up” rather than “top-down” strategy for children with IBD. In pediatric patients with CD, anti-TNF biologic therapy is indicated for severe active disease despite immunomodulatory treatment (step-up) and as a first-line therapy only in patients with a high risk of a complicated disease course, extraintestinal manifestations, or fistulizing perianal CD (top-down).

In pediatric patients with UC, infliximab is indicated in chronically active or steroid-dependent disease uncontrolled by mesalamine and thiopurines. Adalimumab can be considered for those who cannot tolerate infliximab or experience loss of response to infliximab.

However, the reviewers noted that “the good efficacy and safety profile of biologic drugs, along with growing confidence in their utilization,” support increasing the use of top-down therapy in pediatric IBD.

Evidence in the Pediatric Setting

The approval of the infliximab biosimilar CT-P13 for treating both adult and pediatric IBD was based on extrapolation. Studies evaluating biosimilars in IBD have primarily been conducted in adult patients. However, the authors wrote, “data on the effectiveness and safety of biosimilars in pediatric IBD is steadily increasing.”

According to the authors, the available pediatric studies suggested that the infliximab biosimilar has “comparable” efficacy, safety, and immunogenicity to the originator, even after switching. In contrast, there have not been any studies evaluating the efficacy and safety of an adalimumab biosimilar in pediatric IBD yet.

Extrapolating Evidence From Adults to Children in IBD

According to the reviewers, the main concern regarding biosimilars in pediatric IBD is extrapolation from adults to children regarding interchangeability and automatic or non-medical switching. They recommended more studies in pediatric populations to confirm the findings in studies of adult patients.

They cited a systematic review of studies on adult patients that suggested non-medical switching from the infliximab reference product to a biosimilar was safe and had no impact on effectiveness or immunogenicity. However, they said, the analysis only included 3 small randomized controlled trials, and mostly observational cohort studies. They cited a position statement from the American College of Rheumatology, stating that safety in adults does not guarantee safety in children.

On the other hand, they noted the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Pediatric IBD Porto Group, after the release of new safety data, issued a position statement in 2019 stating that switching from the reference product from CT-P13 is safe and well-tolerated in children, “better if in clinical remission and after at least three induction infusions.” They added that multiple switches are not yet recommended in pediatric IBD due to a lack of data.

Confidence in Biosimilars Increasing Among IBD Experts

The reviewers said that recent surveys suggest IBD experts have “increasing awareness” of the efficacy, safety, and cost advantages of biosimilars and increasing confidence in biosimilar use in pediatric IBD. The greater confidence may be due to the publication of post-marketing studies and accumulation of more real-world data.

They offered recommendations to physicians to communicate with and educate patients on biosimilars, including clear communication with positive framing, and including older pediatric patients in the decision-making process. They concluded that CT-P13 is as effective and safe as reference infliximab for children with IBD, and the use of biosimilars “represents a chance to drastically cut healthcare costs and enhance patient access to biologic therapies.”


Dipasquale V, Cucinotta U, Romano C. Biosimilars in pediatric IBD: updated considerations for disease management. Biologics. 2022;16:57-66. doi:10.2147/BTT.S367032

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