Biosimilars Conference

In this session, international regulators from the European Union, Japan, Canada, and the World Health Organization will provide an overview of recent and future policy and regulatory developments in their country/region in the field of biosimilar medicines. An update on lessons learned over the years of existence of the biosimilar pathway will set the scene for what’s coming next and how experience will be factored in regulatory science to shape future evolutions in the biosimilar medicines field in terms of local/regional guidance and its implementation. The impact of international information exchange and collaboration platforms (bilateral and multi-lateral) will also be examined.