A23 – Biosimilars: The evolving regulatory environment

Biosimilar regulation is a rapidly evolving space with the Australian environment largely shaped by international developments. This session will provide insights into the global development of biosimilars, and how the approaches of regulators such as the EMA, FDA and Health Canada impact Australia. The speakers will also explore where regulation and intellectual property intersect, providing examples and ideas on how to navigate a path to biosimilar market authorisation.

 

Chairperson: Dr Greg Pearce, Senior Regulatory Consultant, Commercial Eyes