Regulation of Follow-On Biologics: Ensuring Quality and Patient Safety
An impressive group of experts from the fields of medicine, science, economics, and health policy discuss the quality and safety issues involved in creating a regulatory pathway to bring follow-on biologics, or biosimilars, to market in the United States. Several of the forum speakers participated in a follow-up congressional briefing in November 2009.The discussions provide various perspectives and valuable insights to spur positive action toward assuring that the dual goals of lower costs and patient safety can be met. Speakers include Michael McCaughan, The Pink Sheet; Brian Harvey,MD, PhD, sanofi-aventis; Gundu H.R. Rao, MD, Lillehei Heart Institute; Ann Witt, JD, U. S. Food and Drug Administration; Geno Merli, MD, Thomas Jefferson University Hospital; Judith K. Jones, MD, PhD, Degge Group; Terry Hisey, Deloitte; Laurence Kotlikoff, PhD, Boston University, Randy Vogenberg, RPh, PhD, EPS and Biologic Finance and Access Council.
This supplement is based on a policy forum held at the National Press Club in Washington, D. C., in April 2009, and sponsored by the Jefferson School of Population Health in Philadelphia.