Multi-criteria decision analysis (MCDA) of the adoption of biosimilars in oncology

Abstract: The global market for biologics was $170 billion in 2012, accounting for 19% of the pharmaceutical market. Once patent expiration is reached for a reference biologic, the use of a biosimilar can decrease costs by 25-50%. Although the Food and Drug Administration (FDA) and European Medicines Agency (EMA) have regulations for marketing approval of biosimilars, equivalence studies are conducted among a relatively small number of patients compared to a reference biologic license approval. However, the regulator may also require post-marketing studies. To determine the relative importance of cost savings and post-marketing studies, we conducted an MCDA for the adoption of biosimilars. In addition we assessed differences in perspectives of different stakeholders (oncologists, pharmacist, health payer, regulator/policy maker) and country of residence (US, Netherlands, Germany). This presentation will describe current issues surrounding the adoption of biosimilars, describe the MCDA study, and present our initial findings.