Advances in Adalimumab Biosimilar Usage in a Statewide Health System

Background:
Biologic therapies have revolutionized the management of Crohn’s disease and ulcerative colitis (UC) over the past 2 decades by reducing disease burden, improving quality of life, and minimizing steroid dependence. However, high costs and limited accessibility of biologics have impeded widespread adoption. Biosimilars have emerged as a cost-effective alternative to address these challenges. This case series examines how a statewide health system has incorporated Adalimumab biosimilars into clinical practice. By assessing relative efficacy and time-to-treatment initiation, our goal is to optimize workflows and maximize potential benefits of biosimilars for inflammatory bowel disease (IBD) management.
Methods:
Following IRB exemption, a comprehensive report was extracted from the electronic medical record detailing all Adalimumab biosimilar orders received and dispensed from January 1, 2023, through May 1, 2024, including patient identifiers. Patient charts were reviewed for IBD characteristics and biosimilar tolerability. Data was compiled and analyzed to evaluate treatment outcomes.
Results:
A total of 22 IBD patients managed by a tertiary care center’s specialty pharmacist were prescribed Adalimumab biosimilars, specifically Hadlima (ADA-BWWD), Amjevita (ADA-ATTO), Hyrimoz (ADA-ADAZ), and Yuflyma (ADA-AATY). The cohort was 88% female, 59% White, and 32% African American, with an average age of 37 years. Crohn’s disease was present in 64% of patients and 36% had UC. Medicaid was the predominant insurance provider, followed by Blue Cross Blue Shield. Data on prior biologic, immunomodulator, and steroid use were collected. Nine percent of patients received concomitant immunomodulators, and 9% used steroids while on the biosimilar. Laboratory results showed the following averages: ESR 18.4 mm/hr, CRP 2.2 mg/dL, fecal calprotectin 394 mcg/g, hemoglobin 12.9 gm/dL, iron 68.7 mcg/dL, TIBC 341 mcg/dL, and albumin 3.97 g/dL. Two patients were tested for HLADQA1*05, 1 of whom was positive. Adverse events occurred in 18% of patients. One patient experienced a serious event that required hospitalization for small bowel obstruction, likely due to disease worsening. Injection site reactions were the most common adverse effect, reported in 13% of patients, while 5% experienced a disease flare. Patients who could not tolerate the biosimilar were switched back to the originator. Majority of patients (82%) continued to respond to TNF-alpha therapy and remained on the biosimilar without difficulty. Time-to-treatment initiation averaged 2-4 business days from insurance approval to medication dispensation via specialty pharmacy, compared to 7-10 business days when dispensed through retail pharmacies. On average, patients received their medication 3.5 days after order entry.
Conclusions:
Adalimumab biosimilars demonstrate comparable efficacy to the originator drug and are generally well-tolerated. The most common adverse effect is injection site reactions, potentially linked to the citrate-based formulation of the biosimilars. Laboratory values varied with disease severity and previous biologic failures. Time-to-treatment initiation for biosimilars is comparable to that of the originator drug. Challenges included delays in dispensing medication due to prior authorizations, retail pharmacy availability issues, and a 30-business day appeal process for switching back to the originator. Although insurance mandates largely drive the switch from originator to biosimilar, shared decision-making between providers and patients is essential for a smooth transition in biologic therapy.