9th International seminar on Biosimilars

The presentation will cover the following areas:

*Biologics and Biosimilars FDA and EMA regulatory framework:

-Compare and contrast mindsets, guidelines and experience
-Definitions of biosimilars, interchangeability, switching
-Insights and practical applications
-Worldwide influence of biosimilars arising from EMA

*Developing a Biosimilars Program with US or EU focus:

-What to consider? Building on a EU biosimilar package
-Lessons learned from past EU and US experience
-Merits of EMA Scientific Advice or FDA BsUFA meetings
-Quality testing and essential supportive in vitro testing
-Nonclinical development: too much, too little?
-Huge logistic challenges of clinical work in biosimilars