BIOSIMILARS AND ANALYTICAL CHALLENGES

Thursday 23rd April 2009

RPS, London

Small differences in manufacturing processes or formulations can have significant effects on product safety and efficacy, so biosimilar products are not authorised in the European Union or the USA through the simplified procedures allowed for small molecule generics. This symposium provided 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.

Final Programme

PJ Report

Full report

Speakers' slides