New versions of innovator biopharmaceutical products present multiple challenges for manufacturers and regulatory agencies alike. Small differences in manufacturing processes or formulations can have significant effects on product safety and efficacy. Consequently, biosimilar products are not authorised in the European Union or the USA through the simplified procedures that are allowed for small molecule generics.
This symposium will provide an overview of the regulatory and intellectual property landscape for biosimilars, before examining advances in techniques to compare chemical and functional properties and then presenting case studies in this field.
This symposium will provide an overview of the regulatory and intellectual property landscape for biosimilars, before examining advances in techniques to compare chemical and functional properties and then presenting case studies in this field.
