To Be Or Not To Be Interchangeable: Global Biosimilar Development

By Antonina Nikolova, PhD, Principal Regulatory Consultant, Kymanox Corporation

The approval of biosimilars, which are affordable alternatives to existing biologics, has gained traction in recent years. However, differences in the approval process among regulatory agencies pose challenges for biosimilar developers. Interchangeability, or the ability to use a biosimilar in place of the reference biologic, has been a topic of discussion. In the US, biosimilars must achieve interchangeability status to be considered equivalent to the reference biologic, requiring additional studies to demonstrate similarity. Currently, only seven molecules have achieved interchangeability status in the US. However, the FDA has proposed removing the interchangeability designation from biosimilar labels, stating that both biosimilar and interchangeable biosimilar products can be prescribed with equal confidence. This decision may create challenges for sponsors wanting to make marketing claims and may make it harder for patients to access more affordable biologics.

The regulations for interchangeability of biosimilars vary across countries. In Canada, a biosimilar's authorization does not automatically make it equivalent to the reference biologic, and interchangeability is determined by provinces and territories. In the EU, once a biosimilar is approved, it is automatically considered interchangeable. In Australia, interchangeability refers to switching one medicine for another with the same therapeutic intent. The question of whether interchangeability is beneficial remains, as achieving interchangeability status is a complex process that limits patient access to biosimilar options. Learn more about the role of interchangeability in the biosimilars market and how it can help reduce costs for patients to access biologic therapies.