Inflammatory bowel disease (IBD) is a chronic, immune-mediated condition with a relapsing-remitting course. It primarily encompasses Crohn's disease (CD) and ulcerative colitis (UC) [1]. Chronic intestinal and systemic inflammation leads to a myriad of symptoms in a relapsing-remitting fashion, significantly affecting patients' quality of life, often necessitating hospitalization, surgery, and ongoing clinical, biochemical, and instrumental monitoring [2]. Data show that the cumulative hospitalization rates for CD and UC patients range from 23 % to 49 % and 9 %–33 %, respectively, within the first year [3]. At the five-year mark, hospitalization rates increase to 44%–54 % for CD and 18%–54 % for UC. Additionally, within the first five years post-diagnosis, the cumulative surgery rates are 5%–10 % for UC and 10%–40 % for CD [3]. However, population-based studies from across the globe reveal a consistent decline in surgery rates over the past sixty years. This trend has continued with the introduction of biologics, including TNF-inhibitors, suggesting that these treatments may offer a beneficial, disease-modifying effect [4]. In the U.S., estimates for the direct annual costs incurred by IBD patients range from $7824 to $41,829 [5]. Outpatient expenses account for 19 %–45 % of direct costs, while inpatient costs range from 27 % to 36 %, and pharmacy expenses contribute 7 %–51 %. In European countries, the average cost per patient per year during a 5-year follow-up was €3542 for patients with CD and €2088 for UC patients [3]. Healthcare costs were highest during the first year of treatment and declined in the subsequent years. Hospitalization and diagnostic procedures made up more than 50 % of costs in the first year. However, in the later years, spending on biologics significantly increased, accounting for 73 % of costs in CD and 48 % in UC by the fifth year [3]. In terms of therapy management, treatment options for IBD include conventional medications such as aminosalicylates, corticosteroids, and immnomodulators (i.e., thiopurines and methotrexate), as well as newer advanced therapies like biologics and targeted small-molecule drugs [6,7]. The introduction of advanced therapies in recent decades has significantly redefined the therapeutic approach to IBD, with current treatment strategies now largely dependent on these agents [8]. Unfortunately, the prices of biologics are significantly higher than those of traditional medications, creating a substantial burden on healthcare systems and limiting access to treatment in resource-constrained settings. Available data indicate that biologics cost €1782 per year for patients with CD and €286 for UC patients in Europe [9]. The high cost of biologics is partly attributable to patent protections that restrict market competition. However, with patents beginning to expire in recent years, other manufacturers have started producing and selling biosimilar molecules at competitive prices [10]. Biosimilars are therapeutic monoclonal antibodies that are highly similar to an existing approved reference biologic, demonstrating no clinically meaningful differences in safety, purity, or potency [11]. They were developed to help reduce some of the financial burden while providing the same treatment benefits as the reference biologic [11,12]. Biosimilars are created using the same type of living source and are administered via the same route, frequency, and dosage as the reference product (RP) [11]. In the pursuit of innovation in medical therapy for IBD, enhanced versions of approved biological drugs have been developed, leading to the emergence of the new concept of "biobetter" [13]. This review aims to provide an overview of the concepts of biosimilar and biobetter drugs, the current products available for IBD treatment and their role in the therapeutic landscape, as well as their advantages and future prospects.
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