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

We regret to inform you that the DIA-FDA Biosimilars Workshop scheduled for February 3-4, 2025, in Hyderabad, has been postponed until further notice. This decision follows the U.S. Administration's directive for the FDA to temporarily halt all travel and participation in external meetings. We sincerely apologize for any inconvenience caused and will provide updates as soon as they become available. Thank you for your understanding.

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.

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.

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

Overview

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Learning objectives

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