Biography
Biography: Oxana Iliach,
Abstract
Biosimilars is still a relatively new and rapidly developing area of biologics; as such there are ongoing changes in regulatory requirements for biosimilars in different countries across the globe. Recent changes in regulatory requirements in USA and EU have definitely attracted much attention and sparked many comments and discussions. In light of changes in these two jurisdictions, the regulatory landscape in Canada is somewhat overlooked. However, a few interesting and exciting changes in regulatory requirements for Subsequent Entry Biologics (SEBs) have occured in Canada in the last year. Examples include the revision of the guidance document “Information and Submission Requirements for Subsequent Entry Biologics (SEBs)” and the SEB Scientific Advice Meeting Pilot project.This presentation will address the following questions: Are there more differences than similarities between Health Canada, FDA and EMA regulatory requirements, and what is the future perspective?