Authorizations, Prices, and Labeling Differences of Therapeutic Biologics Marketed in the United States and Saudi Arabia

<p>BACKGROUND: Since 1982, Saudi Arabia (SA) and the United States (US) have seen an increase in therapeutic biologics authorization. However, each country has regulatory regulations governing the approval of these cutting-edge drugs. The high cost of biologics financially burdens healthcare systems and delays patient access to these treatments. Sometimes a company selling the same medications in various countries will have conflicting information on drug labels.</p> <p>OBJECTIVES: This study compared the characteristics of therapeutic biologics authorization by the Saudi Food and Drug Authority (SFDA) and Food and Drug Administration (FDA) as of December 31, 2021. The study also compared the US and SA biologics prices between 2016 and 2019. This study also assessed the differences in indications and safety information on the therapeutic biologics labels authorized by the FDA and SFDA between 1982 and 2021.</p> <p>METHODS: Authorization information was collected from Orange Book, Drugs@FDA, Purple Book, and the SFDA website. We used the Centers for Medicare and Medicaid (CMS) and Veterans Affairs websites to collect US prices. Saudi prices were obtained from annual bulletins distributed by the National Unified Procurement Company (NUPCO) to governmental hospitals. Labeling information was collected from labels.fda.gov and the SFDA website. We used descriptive statistics, as well as linear mixed-effect and logistic regressions.</p> <p>RESULTS: The number of therapeutic biologics authorized by both agencies increased over time, with a particularly high number of orphan-designated and FDA-priority review biologics. Biologics approved by the European Medicines Agency (EMA) and those in the therapeutic classes of antineoplastic and immunomodulating agents and blood and blood-forming organs were found to be statistically associated with availability in Saudi Arabia (p</p>

Name thesis:degree_name

Doctor of Philosophy (PhD)

Level thesis:degree_level

Dissertation

Discipline thesis:degree_discipline

Pharmaceutical Sciences

Year dc:date.available

2023

Author dc:creator

• Altowairgi, Turki

Contributors dc:contributor

• Enrique Seoane-Vazquez
• Lawrence M. Brown
• Marc L. Fleming

• Biologics
• Prices
• FDA
• Authorizations
• Labeling
• SFDA
• Other Pharmacy and Pharmaceutical Sciences
• Pharmacoeconomics and Pharmaceutical Economics
• Pharmacy Administration, Policy and Regulation
• Pharmacy and Pharmaceutical Sciences

Repository record dc:identifier

https://digitalcommons.chapman.edu/pharmaceutical_sciences_dissertations/29

OAI identifier oai:identifier

oai:digitalcommons.chapman.edu:pharmaceutical_sciences_dissertations-1030