Bittner, Beate, Buist, Nicole, Bruin, Gerard, Harris, Kate, Huille, Sylvain, Mittal, Sachin, Printz, Marie, Sanchez-Felix, Manuel, Shih, Hannie, Venczel, Marta and Kang, David (2026) Industry expert perspectives on challenging the myths of subcutaneous delivery. Journal of controlled release, 393 (114800). ISSN ISSN 0168-3659

Abstract

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 FDA 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 misperceptions surrounding this route of administration have challenged its widespread adoption. These include that subcutaneous delivery is painful and limited to small volumes, leads to increased immunogenicity, has low and/or unpredictable bioavailability, and requires extensive clinical trials when bridging between route of administration formulations or devices. This expert perspective article 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 that these misperceptions have been overcome. This review discusses the current state of the field, highlights unresolved challenges and recent breakthroughs, and presents expert perspectives on the future outlook regarding each of these areas. The authors anticipate that new developments in subcutaneous delivery of biotherapeutics will advance adoption across disease areas and improve the overall patient experience.

Item Type:	Article
Keywords:	Subcutaneous; Monoclonal antibody; Pain; Immunogenicity; Bioavailability; Clinical development
Date Deposited:	07 Apr 2026 00:45
Last Modified:	07 Apr 2026 00:45
URI:	https://oak.novartis.com/id/eprint/58846