OBJECTIVES: This study intended to compare the characteristics of therapeutic biologics authorized by the Saudi Food and Drug Authority (SFDA) and the US Food and Drug Administration (FDA) as of December 31, 2021, evaluate differences in the market authorization dates of therapeutic biologics authorized by the SFDA and the FDA, and to assess potential factors explaining why some therapeutic biologics marketed in the United States (US) are not authorized in Saudi Arabia (SA).

METHODS: The data of all biologics approved by the FDA was obtained from the FDA website. For the SFDA, data was obtained from the SFDA website. A descriptive analysis was conducted on all variables included in the study. Logistic regression was used to evaluate the factors associated with the likelihood of the authorization of a therapeutic biologic by the FDA and the SFDA. The IBM SPSS 26 statistical software and Microsoft Excel were used for the analysis.

RESULTS: The FDA authorized 218 therapeutic biologics during the study period, and SFDA authorized 108 therapeutic biologics. The duration between the SFDA marketing approvals and FDA approval for these biologics was a median of 3 years (range 0-24 years), where most of the biologics were first approved for use in the US. In regression analysis, we found that the availability of biologics in SA was associated with approval by the European Medicines Agency (EMA) (p < 0.05) and the date of approval of the biologics (p < 0.05). Therapeutic classes were also preferentially associated with the availability of biologics in SA, antineoplastic and immunomodulating agents (p < 0.05), and blood and blood-forming organs (p < 0.05).

CONCLUSIONS:: Our analysis found that the FDA has authorized a larger number of biologics than the SFDA and that the time gap between SFDA and FDA approval varies widely, with an average time difference exceeding 4.5 years.