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HOW TO REALISE BIOSIMILARS’ FULL POTENTIAL

Track:
New and Known Substances - how to fit the rules to needs

Day & Time:
March 27, 11:00AM - 12:30PM (Central European Standard Time)

Session Number:
1506

Room Number:
5AB

Type:
Session

Title:
HOW TO REALISE BIOSIMILARS’ FULL POTENTIAL

Chair(s):
Sundar Ramanan, PhD
Director, Global Biosimilars R&D Policy
Amgen Inc., United States

Description:
The increasing uptake of existing biosimilars has generated considerable interest and debate about the future potential of the biosimilars space but despite the widespread optimism, a number of key challenges relating to the known active substance remain – pharmacovigilance, naming and traceability – which if not adequately addressed, can limit the potential of biosimilars before it is fully realised. This session will review these three independent but interlinked challenges, providing case studies and examples to illustrate key points and reflect on what needs to be done to ensure the conversation remains focused on patient safety first.

Presentation(s) & Speaker(s):
Tajani Report Analysis
Thomas Heynisch
Deputy Head of Unit
European Comission, Belgium

EGA Point of View
Martin Schiestl, PhD
Scientific & Regulatory Advisor
Sandoz, Austria

EFPIA Point of View
Sundar Ramanan, PhD
Director, Global Biosimilars R&D Policy
Amgen Inc., United States

Regulator’s Point of View
Peter Richardson
Head of Quality, Human Medicines Evaluation Division
European Medicines Agency, European Union, United Kingdom