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NON-CLINICAL DEVELOPMENT STRATEGIES FOR BIOSIMILAR MONOCLONAL ANTIBODIES

Track:
Innovation in R&D Models

Day & Time:
March 27, 2:00PM - 3:30PM (Central European Standard Time)

Session Number:
1407

Room Number:
Room NO

Level:
Advanced

Type:
Session

Title:
NON-CLINICAL DEVELOPMENT STRATEGIES FOR BIOSIMILAR MONOCLONAL ANTIBODIES

Chair(s):
Guenter Waxenecker
Expert Biologics, Group Leader Non Clinical Assessment
Austrian Medicines and Medical Devices Agency (AGES), Austria

Peter Hongaard Andersen, DrMed, DrSc
Senior Vice President
H. Lundbeck A/S, Denmark

Description:
This session will provide a reflection on the limitations and pitfalls in the non-clinical development of biosimilar monoclonal antibodies from a regulators and industry perspective and finally gives a view on globalized development strategies.

Learning Objective(s):
The objective is to provide guidance on critical aspects in the non-clinical development of biosimilar monoclonal antibodies with a special focus on in-vitro assay results examining Fc effector functionality.

Presentation(s) & Speaker(s):
Non-Clinical Development Paradigms for Biosimilar Monoclonal Antibodies from a Regulators Perspective
Guenter Waxenecker
Expert Biologics, Group Leader Non Clinical Assessment
Austrian Medicines and Medical Devices Agency (AGES), Austria

The Role of Functional Bioessays in the Assessment of Similarity
Cornelius Fritsch, PhD
Fellow, External Bioassay Support
Novartis Pharma AG, Switzerland

Nonclinical Development of Biosimilar Monoclonal Antibodies: A science-based approach in a global environment
Jennifer Sims, PhD
NDA Group/Integrated Biologix, Switzerland