Afshin Safavi
BioAgilytix, USA
Title: Bioanalytical Challenges of Biosimilar Development; Making You Wish You Had a Mirror to Put In Front of the Innovator Drug
Biography
Biography: Afshin Safavi
Abstract
Biosimilars are entering the landscape as patents for major branded large molecule products start to expire over the next few years. This rapid drive is fueled by the potential to reduce treatment costs and increase the accessibility of treatments for everyone around the world. However, generation and approval of biosimilars are not trivial as a biosimilar medicine is essentially a new biological product that is similar (not identical) to a medicine that has already been authorized to be marketed. In this presentation, I will review the bioanalytical challenges and solutions that apply specifically to the analysis of biosimilars in biological samples with a focus on the PK, immunogenicity, biomarker and cell-based assays.
