ABSTRACT
Bo Jin, Sandeep M. Menon, Kerry B. Barker, and Ralph B. D’Agostino
CONTENTS
1.1 Background .....................................................................................................2 1.2 Denitions of Biosimilar ...............................................................................4 1.3 Different Development Requirements for Generic, Biosimilar,
and Innovator Products ................................................................................6 1.4 Stepwise Approach to Demonstrate Biosimilarity and
Assessment of Biosimilarity Based on Totality of the Evidence .............7 1.5 Nonclinical Program for a Biosimilar Development ................................9 1.6 Clinical Program for a Biosimilar Development .......................................9
