Learning Tracks

This session will explore how advances in analytical science, regulatory policy, and risk-based development approaches are reshaping expectations for streamlined biosimilar development. Panelists will discuss the role of analytical similarity as the cornerstone of biosimilar development and how state-of-the-art analytical technologies can support more efficient regulatory pathways while maintaining scientific rigor and patient confidence.

The discussion will examine how characterization of critical quality attributes (CQAs), combined with comprehensive structural and functional assessments using orthogonal methodologies can enable more streamlined biosimilar development. Panelists will explore how these approaches help support designing development programs, and enable more selective and targeted approaches to clinical studies

In addition, the session will address why comparative analytical assessments (CAAs) are generally more sensitive than clinical studies in detecting potential differences between a biosimilar and its reference product, and how increased confidence in analytical data can support more tailored and efficient clinical development programs.

Additional topics may include lessons learned from recent regulatory experience, reference product variability, strategies for addressing analytical differences, technical and manufacturing challenges encountered during biosimilar development. Panelists may also discuss the evolving role of advanced in-silico and in-vitro approaches in supporting biosimilar development.

Moderator: Anthony Narisetty
Associate Director, Regulatory Affairs Biosimilars,  Sandoz

Nina Brahme, PhD, MPH
Senior Clinical Analyst, OTBB, OND, CDER, FDA

Maria Gutierrez-Lugo, PhD
Supervisory Pharmaceutical Scientist, OPQAIII, OPQ, CDER, FDA

Shanthi Rajendran, PhD
Associate Director, CMC, Biosimilars & Specialty; GR&D, Apotex Inc.

Arlene Wolny, PhD, MBA, M.S.
Global Head, Regulatory Affairs, Kashiv Biosciences