CONTENTS
Foreword
3
Giampiero Girolomoni and Paolo Gisondi
Manufacture
4 Manufacturing biosimilars
Theodor Dingermann
Nomenclature
7 Naming conventions and nomenclature
Lluís Puig
Development
9 Concepts and principles: Development in depth
Olga Delgado Sanchez
Pharmacovigilance
13 Traceability and pharmacovigilance
Alain Astier
Legislation/regulation
15 EU regulatory framework for biosimilars
Paolo Rocco, Silvia Franzè and Francesca Selmin
Landscape
18 Evolving landscape of biosimilars current and future
Irene Krämer
Benefits
24 Benefits of biosimilars
Mike Scott
Editor, Secondary Care
Andrea Porter
Art Director
James Depree
Commercial Director,
Secondary Care & Business Health
Greg Damalis