Learning Tracks

This session aims to explore how stakeholders should channel technological innovation with evolving regulatory expectations, policy direction, and patient needs to advance the next generation of biosimilars. This session will focus on the evolving biosimilar landscape, with a primary emphasis on how emerging technologies can transform expectations across industry, regulators (including FDA), policymakers, and innovators.

The session will highlight the need to look outside of the traditional biosimilars toward more complex, differentiated products enabled by advanced next-generation bioanalytical tools and General Artificial Intelligence and Machine Learning-driven analytics. It will also explore how new technologies can enable more agile, flexible, and regionally distributed manufacturing models, including continuous and modular bioprocessing, while placing new expectations on industry to modernize capabilities and operating models.

The session will examine how emerging technologies can redefine scientific and Chemistry/Manufacturing/Controls paradigms, including expectations for deeper molecular characterization, and more robust, data-driven control strategies. It will also address evolving regulatory and policy expectations—particularly the FDA’s increasing emphasis on innovative development approaches, efficient comparability frameworks, and advanced manufacturing controls—alongside broader administration priorities such as supply chain resilience, domestic manufacturing, and onshoring. The session will highlight cross-functional alignment and collaboration across regulatory bodies, including coordination among FDA centers (CDER, CBER, and CVM) and with agencies such as USDA for animal-origin materials, to support consistent oversight of increasingly complex and technology-enabled products.