Drug and country characteristics associated with global approval and launch of FDA-approved novel therapeutics

Global availability of novel therapeutics varies widely across countries and is strongly associated with national income. However, whether drug characteristics are associated with global approval and launch remains unclear.

We conducted a cross-sectional study of therapeutics approved by the US Food and Drug Administration (FDA) between 2008 and 2019, examining global regulatory approval and market launch through February 2026 using data from Citeline Pharmaprojects.

Among 396 FDA-approved novel therapeutics, approval or launch of at least one therapeutic was identified in 119 countries outside the United States. Therapeutics were approved and launched in a median of 36 and 17 countries, respectively. In multivariable drug-level analyses, biologics and therapeutics developed by large sponsors were approved or launched in more countries, infectious disease therapeutics in fewer countries. Drug innovation status, orphan designation, unmet medical need, and safety risk were not associated with global approval or launch. At the country level, high-income level, regulatory maturity, larger populations, and greater healthcare resources were associated with more approvals and launches.

Global approval and launch of FDA-approved novel therapeutics were associated more strongly with country-level characteristics than drug-level characteristics. Improving global access may require addressing both regulatory and commercial barriers to approval and launch.