This workshop will focus on the current state of post-marketing surveillance of biosimilar products in the United States. Participants will gain familiarity with the challenges and approaches and from three perspectives: payers, regulators and researchers. Faculty will discuss the need for surveillance, how the outcomes from research can inform utilization patterns of biosimilars in the current marketplace, highlight key contributions of individual organizations, and the evolving learnings from a collaborative, multi-stakeholder approach.


Participants will be presented with an overview of the current biosimilar market, the need for surveillance in the US, and the research activities using real-world evidence (RWE). We will explore the current approach to pharmacovigilance of biosimilar products in the US, and describe one collaborative approach to post-marketing research. Participants will have the opportunity to learn how the outcomes of this research may provide evidence for payers and healthcare organizations in making decisions on utilization of newly marketed biosimilar products, and how it may support regulatory initiatives such as interchangeability and post-marketing surveillance.