Industry Insight
Fast-Tracking Biosimilars Approval: How to Reduce Time-to-Market
The global biosimilar market has seen significant growth in recent years due to factors such as increasing demand for cost-effective treatment options, rising prevalence of chronic diseases, and pressure to reduce healthcare spending. In this Industry Insight we will explore FDA's Totality-of-Evidence Framework, discuss how to streamline the demonstration of biosimilarity, and expose our approach to the topic.