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University of North Carolina Study Finds Infliximab Biosimilars Comparable to Remicade in Gastroenterology and Rheumatology Clinics


Janssen Biotech's Remicade (infliximab), an FDA-approved tumor necrosis factor inhibitor since 1998 for Crohn's disease, has gained additional approvals for managing ulcerative colitis and rheumatoid arthritis.

© MQ-Illustrations - stock.adobe.com

© MQ-Illustrations - stock.adobe.com

Remicade (infliximab), marketed by Janssen Biotech, is a tumor necrosis factor inhibitor approved by the FDA in 1998 for managing Crohn’s disease. Since then, the biologic has received approval for several other indications, including the management of ulcerative colitis and rheumatoid arthritis.

The Biologics Price Competition and Innovation Act of 2009 opened the path for biosimilar approval for biologics, including Remicade, in an effort to lower healthcare costs for patients and healthcare systems. As a result, the following Remicade biosimilars have been approved within the last decade: Inflectra (infliximab-dyyb), Renflexis (infliximab-abda), Ixifi (infliximab-qbtx), and Avsola (infliximab-axxq).

Despite many clinical trials demonstrating non-inferiority of biosimilars and similar safety profiles compared with their reference products, the use of biosimilars remains relatively low. Although FDA approval of a biologic requires data demonstrating a high similarity to the reference product as well as no clinically significant differences between the two agents, bias against biosimilars remains common among patients and clinicians alike.

In 2021, the gastroenterology and rheumatology outpatient clinics at the University of North Carolina in Chapel Hill collaborated in an initiative to switch patients from Remicade to one of two biosimilar products based on costs at the time of conversion.

Sarah Steedman, Pharm.D. and Jane Giang, Pharm.D., from the UNC Medical Center department of pharmacy conducted a retrospective evaluation of the initiative to analyze the clinical outcomes associated with switching patients from a monoclonal antibody to its biosimilar agent. Steedman and Giang also sought to provide insight into factors involved in successfully switching between biosimilar products.

The results from the analysis were published earlier this month in the Journal of Managed Care and Specialty Pharmacy.

Candidates for the biosimilar conversion initiative included clinically stable patients of the UNC gastroenterology or rheumatology outpatient clinic who were receiving Remicade for a number of conditions, including ulcerative colitis. A total of 180 patients were identified as eligible for conversion. A clinic physician, nurse, or clinical pharmacist made the biosimilar recommendations to eligible participants. Patients were also provided with appropriate educational resources to assist in the decision-making process.

Of the 180 patients, 47.2% were considered appropriate for biosimilar conversion evaluations. Of these, 63.5% were successfully switched to one of two Remicade biosimilars (Renflexis or Avsola). Among those who did not convert to a biosimilar, the most common reason given was patient preference. The patients who were successfully converted to a biosimilar, 87.8% were maintained on the same biosimilar agent without needing to switch to an alternative product.

Reported adverse events were similar between the group of participants receiving Remicade and those receiving a biosimilar product (51.4% versus 48.6%).

The study authors conclude that Remicade biosimilar products appear to be safe and effective. Furthermore, converting clinically stable patients to biosimilar agents significantly increased biosimilar use within the UNC health system, resulting in cost savings for both patients and the healthcare system.

Steedman and Giang wrote, “Ultimately, more work is needed from pharmacists to provide education to both patients and providers on biologic biosimilar products, as this may lead to cost savings passed on to patients and the health care system if biosimilar use is increased.”

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