Biosimilars Conference

This session will discuss advances and convergence in regulatory science which may be specific for biosimilars, but may also be more general topics affecting biosimilars as well as other areas. Topics for discussion could be (non-exhaustive list): • Goals for international regulatory practice standards. How best to implement such including challenges with uneven implementation • The future for tailor made biosimilar development going beyond the current guidelines ie development with no or very limited clinical data to support approval • The inevitable conundrum of scientific advices and guidelines. Scientific and regulatory development moves fast and regulators may be challenged to accept development strategies in scientific advices that ultimately will require revision of one or more guidelines should it become a more general issues. However, updating guidelines are time consuming and will take time. So there will always be a lack-time between what will be acceptable for regulators in a scientific advice and what will be written in the guideline. How do we best handle this?