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Session 4: Novel Approaches for the Clinical Development of Biosimilars
Session Chair(s)
Lisa Hampson, PhD
Senior Director, Advanced Methodology & Data Science
Novartis Pharma AG, Switzerland
Fairouz Makhlouf, PhD
Deputy Director, Office of Biostatistics, Office of Translational Science, CDER
FDA, United States
A biosimilar is a version of a biological product that is highly similar and has no clinically meaningful difference to the FDA-approved reference product. Biosimilars may offer more affordable treatment options to patients. The Biologics Price Competition and Innovation Act (BPCI Act) of 2009 established the approval pathway for biological therapeutic products. It aimed to avoid duplicating costly clinical trials while preserving incentives for innovation. In this session, speakers and panelists from FDA and industry will share biostatistical and clinical perspectives on the clinical development of biosimilars. They will explain the role of comparative clinical endpoint studies in biosimilar clinical development programs. In addition, they will describe approaches for the selection of non-inferiority/similarity margins and propose innovative Bayesian designs and analytical techniques for biosimilar development programs.
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize the purpose of the Comparative Clinical Endpoint Studies in Biosimilar Development Program
- Explain the similarity margins in the biosimilar comparative clinical studies.
- Apply Bayesian designs for biosimilar product development
Speaker(s)
Statistics in Biosimilar Studies: Science and Regulations
Jessica Kim, PhD
FDA, United States
Supervisory Mathematical Statistician
Strategies for Bayesian Thinking in Biosimilars Development
Matthew Psioda, PhD
GSK, United States
Head of Statistical Innovation, Oncology and Vaccines
Novel Approaches for the Clinical Development of Biosimilars
Sarah Yim, MD
FDA, United States
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER