World Biosimilar Congress 2016

In 2015, we saw the crescendo of the Amgen versus Sandoz case after many months of appeals. Along with that legal case, many more are still ongoing in the biosimilar sector. This year also provided a milestone in the ongoing discussions and debates on naming conventions with both the US FDA and WHO providing their individual guidance on such issues.

But what does all this mean for future biosimilar development?

Many questions need answering in order for biosimilars to reach the market success that the industry knows it can attain.

Is there finally confidence from healthcare professionals in administering biosimilar drugs?

Has the science of biosimilar development reached a level regulators are happy with in terms of characterisation and comparison?

Are pricing strategies adequately supporting biosimilar development?

Across two days, industry and thought-leading speakers from across the globe will come together at World Biosimilar Congress 2016 to meet and discuss pertinent topics on biosimilar drug development and healthcare uptake:

The Global R&D and Regulatory Landscape

Designing Biosimilar Development Programmes

Bioanalytics for Biosimilars

Characterisation and Comparison of Biosimilars to Originators

Extrapolation and Interchangeability

Pharmacovigilance in Biosimilars

Legal Considerations for Biosimilars

Biosimilar Uptake and Market Considerations

We are excited to bring together representatives from across the whole value chain who can and are working together to ensure that we are providing cost-effective biologics for payers, prescribers and patients. We hope you can join us in November and look forward to seeing you there.

Key speakers include:

Brian Edwards, Principal Consultant, NDA Regulatory Science
Cecil Nick, Vice President, Biotechnology, PAREXEL
Mark McCamish, Head of Global Biopharmaceutical & Oncology Injectables Development, Sandoz
Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines
Ruediger Jankowsky, Managing Director, Cinfa Biotech GmbH
Pierre Michetti, Gastroenterologist, Centre Hospitalier Universitaire Vaudois
Steffen Thirstrup, Director, NDA Regulatory Advisory Board, NDA Advisory Services
Steinar Madsen, Medical Director, Department of Drug Information, Norwegian Medicines Agency
Tony Williams, General Manager, TWC Pharma Consulting
Uwe Gudat, Head of Safety, Biosimilars, Merck