BIOSIMILARS: DEVELOPING A MORE THOROUGH UNDERSTANDING OF A KNOWN ACTIVE SUBSTANCE

Track:
Known Active Substances

Day & Time:
March 6, 11:00AM - 12:30PM

Session Number:
1006

Room Number:
D201/D202

Type:
Session

Title:
BIOSIMILARS: DEVELOPING A MORE THOROUGH UNDERSTANDING OF A KNOWN ACTIVE SUBSTANCE

Chair(s):
Virginia Lee Acha, PhD,MSc
Director, Regulatory Affairs
Amgen International Inc., United Kingdom

Description:
Just when you thought you knew all you needed to know about known actives, the rapidly developing field of biosimilars is presenting new challenges and opportunities. Taken from three perspectives, this session will address how establishing biosimilarity advances our understanding of known actives. Ironically, this is done whilst biosimilars themselves are not well understood by key stakeholders, such as physicians, patients and the wider public. Each of the presenters will discuss these points, reflecting on key developments and initiatives underway in both the regulatory and policy arenas in Europe.

Presentation(s) & Speaker(s):
Biosimilarity: A better definition of terms and concepts
Christian Schneider, DrMed
Senior Medical Officer
Danish Health and Medicines Authority, Denmark

Biosimilars: Case studies on how to hit the target
Mark McCamish, MD,PhD
Head of Global Development
Sandoz Biopharmaceuticals, a Novartis Company, Germany

Trust through Engagement: Explaining biosimilarity to a wider audience
Virginia Lee Acha, PhD,MSc
Director, Regulatory Affairs
Amgen International Inc., United Kingdom