TL9: Statistical issues and methods in biosimilar
David Li, Pfizer  *Jin Xu, Merck 

Keywords: Biosimilar, equivalence margin

The first biosimilar product was approved by the FDA this March, under the new abbreviated approval pathway. Pfizer is buying Hospira for its biosimilar products. Merck is partnering with Samsung Biopics and Biogen to develop a biosimilar insulin. They are just some samples of biosimilar in the news. Pharmaceutical companies, big or small, are buzzing with activities of biosimilar products. What do we statisticians need to know about biosimilar? What are key statistical issues with biosimilars and how to address them? For example, do you know how to set appropriate criteria to demonstrate your company’s product is ‘highly similar’ to a reference biologic product? Do you know the optimal statistical methods to use? This roundtable will help you keep abreast of the relevant statistical issues. We’ll discuss approaches and methods to demonstrate biosimilarity, and share experiences.