Determinants of New Biological Product Approval by United States Food and Drug Administration (2010-2019)

Biological product research and development (R&D) in pharmaceutical and biotechnology companies has been an emerging trend for finding a novel medication. This paper analyzes the relationship between research-based biopharmaceutical companies’ R&D productivity, patent, pivotal trial and development strategy with the number of new biological product approval by U.S. FDA in order to support the key determinants for accelerating biological product approval. Data was gathered from ten public biopharmaceutical companies with the highest number of new biological product approval in 2010-2019. This study was conducted using pooled regression analysis with estimated generalized least square (EGLS) method to analyze the econometric regression on approval determinants. We found that five-year lagged R&D productivity, pivotal trial and development strategies such as own development, licensing, strategic partnership or collaborative development were stastically siginificant in increasing the number of new biological product approval in research-based biopharmaceutical companies. Furthermore, clinical- and surrogate- end point pivotal trial had significant positive correlation with the number of granted patent and pivotal trial at the time of submission.