By 2020, biological products with sales of around US$23 billion in the EU and US$29 billion in the US are expected to be exposed to biosimilar competition [2]. As more and more biologicals lose their patent protection, it is no wonder that both the pharmaceutical industry as well as regulatory agencies are becoming increasingly interested in biosimilars.

Economic evaluation assesses the cost-effectiveness of a medicine by comparing the costs and outcomes of a medicine with those of a relevant comparator. The assessment of cost-effectiveness of a biosimilar is complicated by the fact that the evidence needed to obtain marketing authorisation from a registration authority does not always correspond to the data requirements of a reimbursement authority.

As a biosimilar is likely to be less expensive than the comparator, e.g. the reference biological, the assessment of the cost-effectiveness of a biosimilar will depend on the relative effectiveness.

Where clinical studies demonstrate the same effectiveness between the biosimilar and its reference biological, then a cost-minimisation analysis will identify the cheapest medicine. However, if there are differences in the effectiveness of the biosimilar compared to its reference biological, then other techniques for economic evaluation will be required. These include cost-effectiveness or cost-utility analyses.

The series of two articles that follow present the use of economic evaluations to guide the use of expensive treatment.

Related articles

Relative effectiveness and cost minimisation for biosimilars

The cost-effectiveness of biosimilars

References

1. Simoens S. Biosimilar medicines and cost-effectiveness. Journal of ClinicoEconomics and Outcomes Research 2011; Published online 2011 February 10. doi: 10.2147/CEOR.S12494

2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars: barriers to entry and profitability in the EU and US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 November 25]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilars-barriers-to-entry-and-profitability-in-the-EU-and-US