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.
The definition and key characteristics of Biosimilars
Biosimilar
safety and interchangeability
The growing importance of PK/BE studies in regulatory approvals
Practical strategies for cost-effective and time-efficient Biosimilar development
Consulting Physician Internal Medicine and Clinical Expert in
Drug (Biosimilar) Development, Netherlands
Medical Officer and Consultant at Biokinetica
Early Phase Institute, Poland
Chief Strategic Advisor at Biokinetica
Chief Operations Officer at Biokinetica
Our main goal is to collect vast experience and knowledge about early phase clinical trials and share it with a broad international audience.
Our seminars are dedicated to professionals with a broad range of experience and lay audience as well. Even if you have years of experience, you will find something interesting, as we would like to focus on sharing the experience of our presenters based on real-life cases.
A discussion with the presenter is foreseen after most panels – please see the agenda.
