Drug Information Association Logo
« Back to Listing

Trends in Biosimilars Regulation Within Developed and Emerging Markets

Regulatory Affairs and Submissions

Day & Time:
June 19, 10:45AM - 12:15PM (Pacific Standard Time)

Session Number:

Room Number:



Trends in Biosimilars Regulation Within Developed and Emerging Markets

Andrew S. Robertson, JD, PhD
Director, Global Regulatory Policy
Merck & Co., Inc., United States

This session will provide an in-depth assessment of current global debates and trends within biosimilars regulation. We will present a detailed comparative analysis of the biosimilars global regulatory landscape, identify areas of consistency, and outline areas where debate is ongoing. Panelists will further explore regional trends in biosimilars regulation, focusing on Latin America and the Asia Pacific region. Finally, we will present data that reflects current thinking on some key areas in biosimilars regulation, such as international naming conventions and regulatory standards for substitution and interchangeability. This discussion will provide insight into areas where there is large agreement in biosimilars regulation, and will help identify issues that would benefit from further global discussion.

Learning Objective(s):
Recognize trends in biosimilar regulatory guidances within both emerging and developed markets; Identify areas of biosimilars regulation that differ between key markets.

Presentation(s) & Speaker(s):
Biosimilars: Evolving Trends in the Global Scenario: Emerging Role of the Asia Pacific Region
Sonica Sachdeva Batra
Director Clinical Development, Biologics
Dr. Reddy’S Laboratories Ltd.- Biologics, India

Interdisciplinary Perspectives on Development of Naming Standards for Biosimilar Medicines
Richard O. Dolinar, MD
Alliance for Safe Biologic Medicines, United States