Navigating the EU Biosimilar Development Pathway [FREE WEBINAR]

The changing regulatory landscape, its impact on clinical development, and practical strategies for success in a Phase I unit.

SPEAKERS
Anton A.M. Franken MD, PhD
Consulting Physician Internal Medicine and Clinical Expert in Drug (Biosimilar) Development, Netherlands

Michal Nowicki MD, MPharm
Medical Officer and Consultant at Biokinetica Early Phase Institute, Poland

This webinar will provide an in-depth overview of biosimilars, including their scientific background, safety, interchangeability, and the latest views on the rapidly changing regulatory landscape.

We will explore how to prepare for the future regulatory focus on PK bioequivalence studies, rather than patient comparative efficacy studies, as the core of the regulatory dossier. What are the clinical implications of this shift?

How can we support future biosimilar development in a cost-effective and time-efficient manner?

This free webinar, sponsored by Biokinetica Early Phase Institute, will combine science, regulatory updates and practical clinical implications. It is designed for anyone involved in biosimilar drug development, including professionals in pharmaceutical/biotech companies and CROs, or those who are looking to start their journey in this area.

Join our free webinar to learn about the latest developments in biosimilars.

This webinar will provide you with a clear overview of biosimilars, including their scientific background, safety, interchangeability, and the current regulatory landscape. You’ll learn the key issues driving this important area of drug development.