The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has recently published a report highlighting the gaps and challenges in the value assessment of biosimilars.

The report brings to light the ongoing debate on how to accurately assess the value of biosimilars, especially when they request reimbursement for the same indication as the reference biologic. The report also touches upon the different regulatory requirements for biosimilars across various jurisdictions.

The aim of this review is to provide an overview of the existing challenges and propose potential approaches to address them. This could pave the way for improved methodologies in economic evaluation and better access to these therapies in different jurisdictions.

Assessing the value of a biosimilar, a biological product highly similar to an already approved biological product, can be done through either a price comparison or a full economic evaluation. The choice of method depends on factors such as the relative efficacy of the reference biologic and the biosimilar, indication extrapolation, and value assessment in biologic-naive and biologic-experienced patients. A price comparison is typically used when the two products differ significantly in terms of costs, but not effectiveness. However, a full economic evaluation is required when the reference biologic is not reimbursed, has not been appraised, or is not the standard of care. Some countries, such as Belgium, France, and the Netherlands, classify biosimilars as products with no added therapeutic value compared to the reference biologic. Therefore, they have implemented an abbreviated pricing and reimbursement pathway for biosimilars. The value assessment of a biosimilar is a dynamic process and may need to be revisited as new evidence emerges.

The ISPOR Special Interest Group on Biosimilars is committed to generating new insights in this field by interviewing experts at Health Technology Assessment (HTA) agencies worldwide.

For the full report follow the link below.