Table 1.

Methodological questions on how the value of biosimilars can be assessed

1	Is there a need to perform an economic evaluation when the biosimilar applies for reimbursement in the same indication and population as the reference product?
2	Is there a need to conduct an economic evaluation of a biosimilar when the reference product is not used in a country or is not reimbursed for that specific indication or population?
3	How do the potential nocebo effect, differences in administration routes and the provision of value-added services impact the value of a biosimilar?
4	How can the value of a second-generation biological product be determined?
5	Is there a need to re-assess the value of the entire product class when next-generation biological products (and their subsequent biosimilars) enter the market?