An industry perspective on clinical development and regulatory strategies for subcutaneously administered high-dose biologics

Key insights discussed include top drivers for SC development, common barriers, use of enabling technologies, and emerging strategies to bridge IV to SC dosing using PK/PD modeling and simulation.

This work highlights the need for continued innovation and regulatory alignment to support patient-centric, at-home administration of biologic therapies. As SC administration continues to evolve, our goal is to support the development of patient-centric, efficient, and scalable high-dose therapies.