Biosimilar Use in IBD Still Lags Behind

Inflammatory bowel disease (IBD) biosimilars have been on the US market since 2016, and biosimilar options have grown significantly, but these lower-cost biologics don't seem to be getting the prescriptions they deserve, according to a 2024 study published in Current Gastroenterology Reports.

There are now four biosimilar versions of Remicade (infliximab) including an injectable approved for maintenance only, “which has demonstrated higher serum drug concentrations with the subcutaneous vs intravenous route,” according to the authors, Anthony Angyal, a clinical instructor of pharmacy at the Cleveland Clinic Foundation and Shubha Bhat, a clinical pharmacist at the Digestive Diseases Institute and the Cleveland Clinic Foundation.

Biosimilars had just a 44% share of the infliximab market as of November 2022, which is puzzling considering that 95% of gastroenterologists said they had prescribed biosimilars of Remicade in a recent Cardinal Health study.

In 2023, biosimilars for Humira (adalimumab), which also is used to treat IBD, also came on the market; and the FDA approved the first biosimilar of Stelara (ustekinumab), another IBD treatment. The uptake of Humira biosimilars has so far been disappointing, Angyal and Bhat said, and the Stelara biosimilar will not launch before 2025, owing to a settlement agreement with Johnson & Johnson, the manufacturer of Stelara.

The prevalence of IBD, which includes Crohn's disease and ulcerative colitis, has increased. Globally, it affected 6.8 million individuals in 2017, up from 3.7 million in 1990. In 2018, roughly one in 200 Medicare fee-for-service beneficiaries ≥ 67 years had received the diagnosis of CD or UC; and since 2001, the highest increase in the disease has been seen among non-Hispanic black individuals, according to the Centers for Disease Control.

The medical community is not clear on what's causing the outbreak of IBD. It appears to be more common in developed nations and in urban areas compared to rural one. Some scientists elieve that environment and lifestyle are to blame. “It seems fairly clear that individuals suffering from IBD have disordered or disrupted intestinal microbiota; however, it remains unclear whether this dysbiosis is the cause or the result of the disease,” Stephen H. Borowitz, MD, of the Division of Pediatric Gastroenterology, Hepatology and Nutrition, University of Virginia, wrote in Frontiers in Pediatrics (2022). The greatest risk of developing IBD is having an affected mother or sibling.

Noting the direct annual average cost of treating IBD can reach $41,000, Angyal and Bhat recommended measures to promote biosimilar use, such as interventions to boost patient confidence in biosimilars and to offset the nocebo effect, the opposite of the placebo effect whereby people experience negative symtoms stemming from beliefs about an intervention.

The following strategies were offered to overcome the nocebo effect:

• Have physicians show confidence in biosimilars when talking with patients.
• Encourage health teams, including nurse practitioners and pharmacists, to work together to educate patients.
• Modify these strategies based on patient treatment history and education level.
• Be on the alert for risk of nocebo effect through careful patient assessment.

The authors also voiced support for ongoing efforts to discontinue the “interchangeable” label for certain biosimilars because they are all highly similar to the originator products, such that clinical outcomes are not expected to differ.

“Biosimilar utilization can be successful with the right tools and result in significant cost savings,” they wrote.