PDA Letter Article

High Regulatory Expectations for Biosimilars

by Stephan Krause, PhD, AstreZeneca Biologics, Emanuela Lacana, PhD, U.S. FDA, Jens Schletter, PhD, Sandoz, and Rebecca Stauffer, PDA


The development of biosimilar products continues to gain momentum across the world. The path forward, however, remains arduous, requiring protracted dialogue between the industry and global regulators. And nowhere was this more apparent than at the 2017 PDA/FDA Biosimilars Conference, June 26–27, 2017 in Bethesda, Md.