Challenging the myths of subcutaneous delivery: An industry expert perspective

Biologics have traditionally been delivered through the intravenous route of administration for both cancer and autoimmune diseases. Over the past decade, subcutaneous delivery has emerged as a promising alternative to intravenous delivery, as evidenced by rising numbers of Food and Drug Administration approvals of subcutaneous treatments. Despite the advancements made in subcutaneous delivery and depending on the maturity of subcutaneous products in a given disease area, several misconceptions surrounding this route of administration have challenged its widespread adoption. These misconceptions include pain and small volume limitations with subcutaneous delivery, increased immunogenicity, low and/or unpredictable bioavailability, and a requirement for extensive clinical trials when bridging between routes of administration, formulations, or devices. This article shares expert perspectives and builds on a workshop entitled "Debunking the Myths of SC Drug Delivery", held in collaboration with industry and academic experts and members of the Subcutaneous Drug Development and Delivery Consortium at the Annual Meeting of the Controlled Release Society in 2024, with the goal of collaboratively gathering evidence to debunk these misconceptions. This review discusses the current state of the field, highlights unresolved challenges and recent breakthroughs, and presents expert perspectives on the outlook regarding each of these areas with the hope that new developments in subcutaneous delivery of biotherapeutics will advance adoption across disease areas and improve the overall patient experience.