Overview

The U.S. Food and Drug Administration’s (FDA) India Office and the Drug Information Association’s (DIA) India Office will host a 2-day workshop on best practices related to biosimilar product development and regulatory submissions to the FDA, including life-cycle management of approved applications.

This joint program offers a unique opportunity for participants to engage with and gain insight from FDA’s Center for Drug Evaluation and Research (CDER) subject matter experts on current regulatory perspectives highlighting a range of topics applicable to biosimilar products. FDA regulators will provide an overview of regulatory requirements for biosimilar and interchangeable biosimilar products. They will also discuss topics covering comparative analytical and clinical data expectations, common deficiency trends in Biological Licensing Applications (BLAs), inspections, post-approval changes, and research and educational efforts about biosimilars for patients and health care providers.

Featured topics

Scientific and regulatory expectations for Chemistry, Manufacturing, and Controls (CMC) ,Comparative Analytical Assessment & Clinical studies
Interchangeability
Biosimilar application review process
Common review deficiencies
Post-approval changes
Major 483 observations
Best practices and real-world examples
Educational efforts for patients and providers, the Purple Book, and other online resources

Learning objectives

The objective of this workshop is to share the Agency’s expectations and current thinking on biosimilar and interchangeable product development and life cycle management. The workshop topics are designed to engage participants in active dialogue and to encourage a better understanding of regulatory expectations related to biosimilar and interchangeable biosimilar products. The workshop will focus on the best practices in submitting and managing biosimilar applications, data expectations, challenges in application review and submission, regulatory support mechanisms, and real-world examples experienced by FDA regulators.

Program Committee

Dr. Constance (Connie) Richard-Math Supervisory Consumer Safety Officer (SCSO)
India Office, US FDA, India
Dr. Jacquin (Jackie) L. Jones International Relations Specialist
India Office, US FDA, India
Mr. Dhruv Shah Senior Technical Advisor
India Office, US FDA, India
Dr. Phuc (Phillip) Nguyen International Relations Specialist, India Office
US FDA, India
Ashok Kumar Swain General Manager, India
DIA, India

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DIA-US FDA Biosimilars Workshop “Navigating Biosimilars: FDA Insights On Development And Lifecycle Management Strategies”

Overview

Featured topics

Learning objectives

Program Committee

Digital Learning Catalog

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