Amgen: Regulatory Reform Must Not Tie The FDA’s Hands On Evaluating Biosimilarity
Biosimilars Executive Leah Christl Offers Amgen’s Perspective On The Need For Efficacy Trials
Executive Summary
As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.