OBJECTIVES: To provide insight into the similarities and differences between the reimbursement of biosimilars in the US and Europe

METHODS: Review of the regulatory pathways, system cost-containment measures such as tender stipulations which affect the reimbursement levels in the US, UK, France, Germany, Italy and Spain.

RESULTS: Within European markets there are fast track and standard processes that allow for the availability of biosimilars, the healthcare system cost containment measures allow discounts verses the originator of between 10% and 75%. In the US the Biologics Price Competition and Innovation Act (BPCIA) provides an abbreviated regulatory approval pathway for biosimilars. A variety of factors can influence the reimbursement levels including the treatment setting, payer programs, average selling price, “white bagging”, compulsory use of specialist pharmacies or the patient care model. However the development of individual Healthcare Common Procedure Coding System (HCPCS) codes and Average Selling Prices (ASP) for each biosimilar has encouraged a more level playing field between originators and biosimilars.

CONCLUSIONS: All markets have faster regulatory pathways for biosimilars. Reimbursement levels within the US are more complex due to the variability in payer programs public (e.g. Medicare- part B / part D, 340B Drug Pricing Program) and private (e.g. Managed Care Organisations).