Download Presentation: Proving biosimilarity with comparability to the reference product at all stages


Biosimilars, as always, are a hot topic in the pharmaceutical space as many blockbuster drugs go off patent and pharmaceutical companies scrambling to develop and register follow on biologics. The World Biosimilar Congress 2012 brought together senior level executives and opinion leaders from around the globe to further their knowledge and engage in discussion on a variety of topics relating to biosimilar development, production and regulations. Attendees at this highly successful event were fortunate enough to hear this exciting presentation delivered by Dr Regine Buffels, CEO, Medical Consulting International, ‘Proving biosimilarity with comparability to the reference product at all stages'.


This presentation focuses on:

· Design specification: physicochemical and biological characterisation

· Validation: PK/PD and pre-clinical studies

· Clinical development


Download this presentation here.


Are you interested in learning more about biosimilars? Then you might be interested in attending the World Biosimilar Congress 2013. This event is set to discuss the global biosimilar development landscape, regulations, process development, clinical trial considerations, pharmacovigilence and a host of other topics. Or if you're interested in antibodies, this event is also co-located with the European Antibody Congress 2013. Both these events are taking place in Geneva this November.

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