Biosimilar Approval Pathways: Comparing the Roles of Five Medicines Regulators

The authors compare the regulatory approval process for biosimilars in five jurisdictions (Australia, Canada, EU, UK, and US), noting differences in biosimilar testing requirements and policies regarding indication extrapolation, exclusivities, and biosimilar substitution. Understanding the impact of these policies on biosimilar approval and uptake is important to strengthen the global biosimilar market.