Executing Trials For Proposed Biosimilars: Challenges And Best Practices

By Carolyn Finkle, Shannon Williams, Dannelle Palmer, MBA, PMP, Renee Vaughn, RN, BSN, MBA, PMP, JB Flinders, MPH, MBA, and James Rung

Trials to establish biosimilarity between an innovator biologic and a proposed biosimilar are a relatively new phenomenon, especially in the US, where the first biosimilar has only recently entered the market. The regulations, methodologies, and assumptions typically applied in developing novel investigational products may not apply to biosimilar development, as the objective of such clinical studies is different. Biosimilar clinical studies are designed to demonstrate a high degree of similarity to the reference biologic product rather than establishing safety and effectiveness as in studies of a novel drug.

In this paper, we discuss how executing Phase III trials for biosimilars differs from that of New Chemical Entities (NCEs). Sponsors should understand from the outset that they will need to build in additional planning time and adopt tailored strategies for assessing feasibility, selecting sites, recruiting patients, procuring the comparator product, and ensuring the integrity of the study blind.