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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)
Biosimilarity and the Challenges in Desigining a Global Regulatory Program
Cecil J. Nick, MS
Parexel Consulting, United Kingdom
FTOPRA, Vice President (Technical)
The Regulatory Pathway of Biosimilars - From Regulatory Guidance to the Assessment of Data
Pekka T Kurki, MD, PHD
Finnish Medicines Agency, Finland
Research Professor
A Global Regulatory Biosimilar Program - Rising to the Challenge
Heui Yun Joo
Celltrion Inc., Korea, Republic of
Manager, Purification Process Team