Last week, Bruno Flamion, member of the NDA Advisory Board, was a keynote guest speaker at the 4th Biosimilars Congregation 2014 in London. He discussed the very topical issue of the evolving regulatory approach to Biosimilars in the EU, particularly in view of the first approval for a biosimilar monoclonal antibody (infliximab). As the next presentation focused on the FDA guideline for biosimilar development, a rich debate ensued comparing the regulatory approaches on both sides of the Atlantic.
The event was attended by top pharmaceutical, biotechnology and regulatory representatives, collectively interested in the key issues facing the industry today. This ranged from the evolving regulatory landscape and challenges in clinical development, to the legal and economic aspects. The conference focused on the many features of biosimilar product development to successfully deliver safe, biosimilar products to the market place.
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Professor Bruno Flamion member of NDA’s Advisory Board