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Breakout Session 2A: Biosimilars
Session Chair(s)
Cecil J. Nick, MS
FTOPRA, Vice President (Technical), Parexel Consulting, United Kingdom
Biosimilarity is a concept first introduced into European legislation almost a decade ago to allow regulatory approval of similar biological medicines following submission of limited yet targeted data showing similarity to the reference biological product based on the totality of physico-chemical, biological, non—clinical and clinical testing. This concept has now spread across the globe with guidelines and regulations issued by all major regulatory agencies including WHO and those in US, Japan, Canada and Korea. This session will explore various view points on the critical considerations applicable to making affordable yet safe and effective similar biological medicines available globally.
Speaker(s)
Cecil J. Nick, MS
FTOPRA, Vice President (Technical), Parexel Consulting, United Kingdom
Biosimilarity and the Challenges in Desigining a Global Regulatory Program
Pekka T Kurki, MD, PHD
Research Professor, Finnish Medicines Agency, Finland
The Regulatory Pathway of Biosimilars - From Regulatory Guidance to the Assessment of Data
Heui Yun Joo
Manager, Purification Process Team, Celltrion Inc., Korea, Republic of
A Global Regulatory Biosimilar Program - Rising to the Challenge
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