The global status of bioequivalence trials: a comprehensive clinical trial landscape analysis based on the Trialtrove database

This study presents a comprehensive analysis of the global bioequivalence (BE) trial landscape over the past 21 years, utilizing data from the Trialtrove database. We analyzed 12,450 BE trials conducted from 2003 to 2023, revealing a significant upward trend in trial numbers. Among the analysis, the primary therapeutic areas identified were cardiovascular diseases (23.17%) and metabolic/endocrinology conditions (18.91%). China leads in BE trials, accounting for 57.20% of the total, followed by Russia and the United States. Most trials are sponsored by the industry, predominantly by generic pharmaceutical companies. This study highlights the importance of diverse representation in trial populations to enhance the validity of results. We discuss strategies for improving trial success rates, including preliminary trials and in vitro dissolution testing. Furthermore, the need for international harmonization of generic drug standards is emphasized, along with the potential impact of advanced technologies, such as artificial intelligence, on future BE research.