The Alliance for Safe Biologic Medicines (ASBM), the International Cancer Advocacy Network (ICAN) and AZBio hosted “Biosimilars Policy Forum: Ensuring Patient Safety” on September 27, 2012 in Phoenix, AZ, to discuss the complex challenges the Food and Drug Administration (FDA) faces as it seeks to establish a regulatory pathway that will lead to the approval of biosimilars in the U.S.
The forum, held at the Flinn Foundation in downtown Phoenix, brought together patients, physicians, pharmacists, researchers and other stakeholders. Following a “Biosimilars 101” presentation by Dr. Dolinar, Patricia Lucente with the Colon Cancer Alliance provided her perspective as a patient advocate and then Joan Koerber-Walker, CEO of AZBio moderated a panel discussion with Dolinar, Lucente and:
Philip J. Schneider, Professor and Associate Dean of the University of Arizona College of Pharmacy, Eric Thompson, PhD, Director of Biomarker Research for Paradigm and International Genomics Consortium and Brett Johnson, PhD, International Cancer Advocacy Network
Panelists agreed that patient-safety is and should remain the focal point of efforts to bring biosimilars to the U.S. It was also generally agreed that there is an information deficit with the general public about these new innovative medicines, and that the forum was a great start to closing that gap and informing the public.
There was overwhelming agreement that healthcare providers, especially physicians and pharmacists must work to seek common ground on issues like notification and substitution.
We thank all of our speakers for their comments and look forward to holding a follow-up event to continue the dialogue.