HPE HPE Fresenius Kabi handbook - Page 2

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