Symposium D4: Non-Biological-Complex-Drugs

Wednesday 24 May 2017
09:00-12:00
Stockholmsmässan : A2

Introduction

The rise of bio- and nano-technology has accelerated the development of complex drugs, a class of products that include – but are not limited to – biologic and Non Biological Compel Drug (NBCD) products such as iron-carbohydrate complexes, glatiramoids, polymeric micelles, emulsions, liposomes and other products in the class of nanomedicines. While guidance for developing generic versions of small molecule drugs is well- established and guiding principles for biosimilars and some follow-on versions of NBCDs are evolving, the regulatory science debate is still going on and many basic questions are left. Moreover, alignment of science based international approaches to the approval of these complex drug products and their follow on versions would be highly desired for those companies that develop follow-on versions. At the moment, this alignment of the legal frameworks is still 'under construction', at best.

Co-Chair(s): Stefan Mühlebach, Switzerland and Daan Crommelin, the Netherlands

Programme

09:00 - 09:10 Introductory remarks
Stefan Mühlebach, University of Basel, Switzerland and
Daan Crommelin, Utrecht University, the Netherlands

09:10 - 09:45 Nanomedicines: complex in nature and a challenge for innovator and regulator
Gerrit Borchard, University of Geneva, Switzerland

09:45 - 10:20 The growing analytical toolbox for complex drugs: Assessment of NBCD bioequivalence
Scott McNeil, National Cancer Institute, USA

10:20 – 10:40 BREAK

10.40 – 11:15 Is the EU regulatory network ready for "complex non-biological drugs"?
Falk Ehmann, European Medicines Agency, UK 

11:15 - 11:50 How do we rapidly develop and manufacture high quality biosimilars?
Paul Song, Samsung Bioepis, Korea

11:50 – 12:00 Concluding remarks
Stefan Mühlebach, University of Basel, Switzerland and
Daan Crommelin, Utrecht University, the Netherlands

With the support of:
Non-Biological-Complex-Drugs (NBCD) Working Group and TUFTAD