High Regulatory Expectations for Biosimilars
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.
The conference opened with a review of current international regulators’ expectations for approval of biosimilars, featuring presentations from Steven Kozlowski, MD, Supervisory Medical Officer, CDER, U.S. FDA, and Niklas Ekman, PhD, Senior Researcher, Finnish Medicines Agency. Kozlowski provided an overview of FDA’s involvement with biosimilars, pointing out that additional draft guidance documents will become available to assist biosimilar developers. The Agency’s position on similarity is that analytical testing is the foundation.