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Prevalent-New User Design for Biosimilar Safety Using Saudi Real-World Data
Ohoud Almadani1, Almaha Alfakhri1, Ibrahim Asiri1
1Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Pharmacoepidemiology and Drug Safety
|May 27, 2026
Summary
This study found no significant difference in infection risk between biosimilar and reference biological disease-modifying antirheumatic drugs (bDMARDs) in a Saudi real-world cohort. Further research is needed to enhance biosimilar surveillance using prevalent new-user designs.
Area of Science:
- Rheumatology
- Pharmacovigilance
- Real-world evidence
Background:
- Infections are a concern with biological disease-modifying antirheumatic drugs (bDMARDs).
- Post-marketing surveillance of biosimilar bDMARDs is crucial for patient safety.
Purpose of the Study:
- To evaluate the infection risk associated with biosimilar bDMARDs compared to reference bDMARDs in a Saudi population.
- To assess the utility of a prevalent new-user study design for biosimilar safety monitoring.
Main Methods:
- A real-world cohort study using the Saudi Real-World Evidence Network (SRWEN) from 2016-2025.
- Implemented a prevalent new-user design with time-conditional propensity score matching.
- Assessed infection risk using ICD-10 codes, laboratory results, and antimicrobial prescriptions.
Main Results:
- 5721 patients with 59,856 treatment episodes were analyzed; adalimumab was the most used drug.
- Infection incidence rates were similar between biosimilar and reference bDMARD users (456.7 vs. 422.0 per 1000 person-years).
- No statistically significant difference in infection risk was found (adjusted HR 0.89; 95% CI 0.57-1.39).
Conclusions:
- No significant difference in infection risk between biosimilar and reference bDMARDs in the Saudi cohort.
- The prevalent new-user design is applicable for biosimilar surveillance.
- Larger studies are recommended to further validate findings and enhance post-marketing surveillance.
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