Unlocking hope: The future of ustekinumab biosimilars in Crohn's disease treatment.

Biologic therapies have revolutionized Crohn's disease (CD) management, but their high costs pose a significant barrier to access. Biosimilars can provide increased access to treatment because of significant cost-savings. Ustekinumab is a biological drug against interleukin 12-23 that is employed in treating moderate-to-severe CD. As the patent of the reference product (RP) is expiring, ustekinumab biosimilars have been developed and are currently becoming available for patients. Available data demonstrate that ustekinumab biosimilars exhibit comparable efficacy, pharmacokinetics, safety and immunogenicity as the RP. Ustekinumab biosimilars have been approved for CD based on extrapolation and there is no real-world data available yet for this indication. While biosimilars of ustekinumab promise cost savings in treating moderate-to-severe CD, it is not yet known whether their availability will change the treatment algorithm in CD. This review focuses on the available data on ustekinumab biosimilars, focusing on their pros and cons for their forthcoming role in treating moderate to severe CD.