Trend in approval of targeted biologics in the last two decades

Abstract

Over the past two decades, the approval of targeted biologics has significantly transformed therapeutic landscapes, particularly for chronic diseases like cancer. These therapies, specifically target diseases' molecular pathways, offer enhanced efficacy and fewer side effects than traditional chemotherapy. This review assesses the trends in regulatory approval by the FDA, noting a surge in approvals for targeted biologics over the last two decades. The shift towards targeted biologics promises more precise management of the complexities of cancer. This review compiles the FDA's trends in approving targeted biologics for cancer from January 2000 to December 2022 based on product class, rate of approvals, biological target, and disease site. Despite the advancements in targeted cancer therapies, there is a need to comprehensively understand the evolving trends in FDA approvals during the twenty-first century. This study investigates the approval patterns, identifies influencing factors, and provides insights that can contribute to optimizing the development and processes of targeted biologics. This may serve as a good insight for researchers in academia and industry to identify fields in which cancer research and funding may be mostly directed.