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BIOSIMILARS- BUILDING ON EUROPEAN FOUNDATIONS TO ACHIEVE GLOBAL HARMONISATION

Track:
Regulatory Science

Day & Time:
March 27, 9:00AM - 10:30AM (Central European Standard Time)

Session Number:
0105

Room Number:
Room E1

Type:
Session

Title:
BIOSIMILARS- BUILDING ON EUROPEAN FOUNDATIONS TO ACHIEVE GLOBAL HARMONISATION

Chair(s):
Judith McDonald
Senior Director, Global Regulatory Lead
Pfizer, United Kingdom

Description:
The session will review the fundamental tenets of the biosimilar concept as pioneered by the European regulators and why upholding these is of central importance in view of the fact that these concepts are sometimes misunderstood by stakeholders. We will review the challenges faced by companies in applying these concepts in a global setting and will conclude with a discussion on stakeholder education followed by a panel discussion.

Presentation(s) & Speaker(s):
European Regulation of Biosimilars - past, present and future
Martina Weise, MD
Head, Unit on Diabetes/Cardiology, German CHMP Alernate
Bfarm, Germany

The Role of Analytics and Clinical Studies in the Development of Biosimilars
Joerg Windisch, PhD
Chief Science Officer
Sandoz Biopharmaceuticals, Austria

Overview of Regulatory Challenges in Applying the Biosimilar Concept Globally
Judith McDonald
Senior Director, Global Regulatory Lead
Pfizer, United Kingdom

Education of Stakeholders on biosimilar concepts - why does it matter globally?
Virginia Lee Acha, PhD, MSc
Director, Regulatory Affairs
Amgen International Inc, United Kingdom