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Insurance-Driven Switches to Adalimumab Biosimilars Maintain Disease Control in Pediatric Inflammatory Bowel Disease

Insurance-Driven Switches to Adalimumab Biosimilars Maintain Disease Control in Pediatric Inflammatory Bowel Disease 1024 683 Pam Georgiana
Woman in scrubs with a stethoscope talking with teen.

New pediatric data may help clinicians reassure patients and families about nonmedical treatment switches

Since biosimilar versions of adalimumab became available in the United States in 2023, more insurers have required patients receiving the originator medication to switch to a biosimilar. Researchers have deemed biosimilars safe and effective alternatives in adults. However, there is limited pediatric-specific evidence, particularly for inflammatory bowel disease (IBD).

For families whose child’s disease is well controlled, an insurance-mandated change creates understandable concern.

“Our patients are being asked to switch from a medication that is working for them,” says Daniel Himelstein, MD, pediatric gastroenterology fellow at Nationwide Children’s Hospital. “We wanted to understand what happens clinically after that switch so that we can provide patients and families with more information about what they can expect.”

Dr. Himelstein and colleagues conducted a retrospective study of 50 children and young adults with Crohn’s disease or ulcerative colitis treated at Nationwide Children’s. These patients underwent an insurance-mandated switch from adalimumab to a biosimilar between May 2023 and July 2024. The results were published in JPGN Reports.

The research team compared clinical disease activity, laboratory markers, adalimumab levels and antibodies before and for up to 6 months after the switch. They also assessed whether patients remained on the biosimilar at 6 months.

“We wanted to focus on clinical outcomes and symptom management in the six months post-switch,” says Dr. Himelstein. “Even more importantly, we wanted to make sure that patients didn’t have to switch medication yet again due to adverse effects.”

Of the 42 patients with physician global assessments available before and after switching, 86% had stable or improved disease activity. Laboratory markers of inflammation and disease activity also remained stable. Adalimumab levels decreased from 18 mcg/mL before the switch to 15 mcg/mL afterward. The researchers did not consider that decrease clinically meaningful.

At 6 months, 38 of the 50 patients (76%) remained on the biosimilar. Of the 12 who discontinued treatment, five stopped for reasons unrelated to the switch. Seven discontinuations were considered switch-related. The reasons for switching included worsening disease, adverse reactions and decreased drug levels.

The results suggest that clinical outcomes, laboratory markers and drug levels were largely maintained following a nonmedical switch to an adalimumab biosimilar in this specific patient population.

For clinicians, these findings are particularly relevant because adalimumab is commonly used to treat Crohn’s disease and ulcerative colitis. They may encounter patients and families who are concerned when their insurer or pharmacy require a change in medication.

“Our research provides evidence that biosimilars are safe and effective and that most patients do well after switching,” Dr. Himelstein says.

Because this was a single-center, retrospective study with 6 months of follow-up, larger, longer-term studies are needed to evaluate the durability of biosimilar therapy and understand how changing insurance coverage and prescribing requirements affect patients.

“This is the beginning of the story,” Dr. Himelstein says. “No previous study has analyzed the clinical implications of switching these medications for pediatric patients with IBD in the United States. More research is definitely needed.”

For now, the findings supply pediatric-specific evidence to help clinicians counsel families facing a nonmedical switch while continuing to monitor disease activity, adverse effects, and treatment response.

 

 

Reference:

Himelstein D, McNicol M, Abdel‐Rasoul M, Boyle BM, Michel HK, Maltz R. Outcomes of adalimumab biosimilar nonmedical switches in children and young adults with inflammatory bowel disease. JPGN Rep. 2026;1‐7. doi.org/10.1002/jpr3.70212

Image Credit: Adobe Stock

About the author

Pam Georgiana is a brand marketing professional and writer located in Bexley, Ohio. She believes that words bind us together as humans and that the best stories remind us of our humanity. She specialized in telling engaging stories for healthcare, B2B services, and nonprofits using classic storytelling techniques. Pam has earned an MBA in Marketing from Capital University in Columbus, Ohio.

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