Biosimilars Conference

Clinical trials currently represent a fundamental component of the biosimilar development program but are the trials that are currently advocated by the regulators designed to address the right questions, and how feasible will such trials be in the future? Often the potential for therapeutic equivalence may be obvious from in vitro, PK, and PD studies without the need for extensive therapeutic equivalence trials. Still, residual uncertainties might persist that only clinical studies in patients can address. Speakers will explore what these issues are and whether clinical trials are always needed; where trials are needed, what questions they should address, and if better approaches exist than are currently applied.