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Follow on Google News | Exclusive Interview with SGS Life Science Services released ahead of Biosimilars and Biobetters 2015SMi's Biosimilars and Biobetters conference, taking place on 30 September - 1 October 2015 in London, will address pharmacovigilance of biosimilars, patent litigation, market access, product commercialisation barriers and global market developments.
By: SMi Group Against this backdrop, in the build-up to the event, SMi is pleased to announce that an exclusive interview with SGS Life Science Services' Global Director of BioPharma Services Development, Dr. Fiona Greer has just been released. When asked to provide an update on structural characterisation, she commented: "The regulatory pathway in both EU and US and indeed many other countries for biosimilars is very different to a novel molecule. It is mandatory to establish and demonstrate bio-similarities between biosimilar and reference product at the analytical level by side-by-side comparison, i.e. physical, biological and chemical characterisation, before progressing into clinical study. Based on the structural characterisation profile, the regulatory authority will ask for different further information and decide what the next step of your programme should be." Download the SGS Life Science Services interview and other exclusive event content at http://www.smi- End
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