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Virtual

Mar 29, 2023 10:00 AM - Mar 31, 2023 4:15 PM

(US Eastern Standard Time)

DIA/FDA Biostatistics Industry and Regulator Forum

Join us virtually from the comfort of your home/office March 29-31 or watch later at a time that works for you. This event provides access to the materials for a full two months!

Session 4: Novel Approaches for the Clinical Development of Biosimilars

Session Chair(s)

Lisa  Hampson, PhD

Lisa Hampson, PhD

Senior Director, Advanced Methodology & Data Science

Novartis Pharma AG, Switzerland

Fairouz  Makhlouf, PhD

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)

Jessica  Kim, PhD

Statistics in Biosimilar Studies: Science and Regulations

Jessica Kim, PhD

FDA, United States

Supervisory Mathematical Statistician

Matthew  Psioda, PhD

Strategies for Bayesian Thinking in Biosimilars Development

Matthew Psioda, PhD

GSK, United States

Head of Statistical Innovation, Oncology and Vaccines

Sarah  Yim, MD

Novel Approaches for the Clinical Development of Biosimilars

Sarah Yim, MD

FDA, United States

Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER

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