Candida Fratazzi
BBCR Consulting,USA
Title: Cost- Effective clinical trial design to detect immunogenicity and efficacy differences between biosimilar and innovator product.
Biography
Biography: Candida Fratazzi
Abstract
Biotherapeutic products are the fastest growing medicines in the pharmaceutical market. Here we discussthe major variables that have an impact on cost and timelines of biosimilars’ development. Specifically, wereport the challenges of duplicating the innovator product results and how the dialogue on indication extrapolation has elicited new interest as the FDA compares extrapolation’s core issues. Accordingly to the WHO “it is expected that the elaboration of the data requirements and considerations for the licensing of Biosimilar products will facilitate development and worldwide access to biotherapeutics of assured quality, safety and efficacy at more affordable prices.” To address the WHO requirements, we have reviewed trial options that could assess interchangeability between the branded product and the biosimilar. Here, we discuss a case study with the objective ofassessing the immunogenicity rate between biosimilar and innovator productand evaluate the data in light of regulatory requirements. Our developed framework based on evidence-based strategies and design-centered trials highlights the factors impacting the potential cost savings in biosimilar development.
