ECONOMIC AND HEALTH SYSTEM CAPACITY ASSOCIATIONS WITH BIOSIMILAR REGULATORY APPROVALS ACROSS COUNTRIES AND INCOME GROUPS

This analysis examines whether economic resources, health financing intensity, and population correspond differently with biosimilar regulatory approvals across national markets. A descriptive cross-sectional dataset combines reported approval stocks with World Development Indicators for 20 countries in 2019. Distributional summaries, ranked group comparisons, Spearman correlations, and exploratory country exclusions assess the observed patterns. Population shows a positive rank correlation of 0.496 with approvals, compared with 0.129 for GDP per capita and 0.045 for health expenditure per capita. Median approvals reach 21.50 in the upper population half and 9.00 in the lower half. Population correlations remain positive across exclusions of India, China, and both countries, ranging from 0.445 to 0.746. Income category means and medians yield different rankings because authorizations are concentrated in particular countries. These findings distinguish potential market scale from financial intensity without identifying causal mechanisms. The contribution refines market capacity interpretation by demonstrating that its dimensions describe different authorization patterns. International benchmarking should distinguish cumulative approvals from active availability and patient access.