ASBM continues to participate in and lead forums across the country to educate patients, physicians, pharmacists and policymakers on the U.S. Food and Drug Administration’s (FDA) efforts to bring biosimilars to patients in the U.S. The intent of the campaign is to highlight the complex nature of biologics, the precise methods and processes required to manufacture them and the challenges presented in the attempt to replicate their structure as the FDA mover forward to create a pathway for biosimilars.
Rhode Island
On December 13, 2012, ASBM co-hosted an educational forum with the University of Rhode Island, College of Pharmacy in Kingston. Prior to the forum, ASBM members participated in a tour of a nearby biologics facility to see first-hand the intricate process of manufacturing biologic medicines.
At the forum, Ron Jordan, Dean of the College of Pharmacy and ASBM Chairman, Richard Dolinar, M.D. discussed how biologics differ from traditional drugs in the fact that biologics are larger more complex molecules, made in proteins and are difficult to replicate. The speakers stressed the importance of the physician and pharmacy communities working together to ensure that processes are put in place to ensure patient safety remain paramount.
Participants included:
Richard Dolinar, MD, ASBM Chairman
Andrew Spiegel, CEO of the Colon Cancer Alliance
Ronald Jordan, Dean of the University of Rhode Island – College of Pharmacy
Bruce Babbitt, PAREXEL Consulting
Doug Kraus, patient advocate
View Dr. Dolinar’s presentation. (Biosimilars: A framework to ensure safe substitution)
Read ASBM press release.
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COLORADO
On December 6, 2013, Chairman Richard Dolinar, M.D., and Executive Director Michael Reilly toured a biologic manufacturing facility in Longmont, CO. Several ASBM members also participated on the tour, which was arranged to help attendees better understand the complexities of manufacturing biologics.
After touring the facility, the group attended a forum co-hosted by Colorado BioScience, BIO and ASBM, which discussed the need for stringent standards when manufacturing attempted copies of biologics known as biosimilars. Also discussed was recently introduced Colorado legislation that is intended to ensure that automatic substitution of biosimilars only be allowed when the FDA designates an approved biosimilar as interchangeable.
“As a practicing physician, I am often reminded of the differences biologics can make in the lives of my patients, but today was an eye-opening experience as I witnessed firsthand the immense detail and the stringent standards that are required to ensure that biologics are safe and effective,” said Dr. Dolinar.
Participants included:
Richard Dolinar, MD, ASBM Chairman
Andrew Spiegel, CEO of the Colon Cancer Alliance
Philip Schneider, Associate Dean of the College of Pharmacy at the University of AZ
Fritz Bittenbender, VP of Alliance Development and State Government Affairs at BIO
View Dr. Dolinar’s presentation.
Read ASBM press release.
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ARIZONA
On September 27, 2012, the Alliance for Safe Biologic Medicines (ASBM), the International Cancer Advocacy Network (ICAN) and AZBio hosted “Biosimilars Policy Forum: Ensuring Patient Safety.” The forum, held at the Flinn Foundation in downtown Phoenix, brought together patients, physicians, pharmacists, researchers and other stakeholders 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.
Panelists agreed that patient-safety is and should remain the focal point of efforts to bring biosimilars to the U.S. and that healthcare providers, especially physicians and pharmacists, must work to seek common ground on issues like notification and substitution. 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.
Participants included:
Richard Dolinar, MD, ASBM Chairman
Patricia Lucente, Colon Cancer Alliance
Joan Koerber-Walker, CEO of AZBio
Philip J. Schneider, Associate Dean of the University of Arizona College of Pharmacy
Eric Thompson, PhD, Director of Biomarker Research for Paradigm and International Genomics Consortium
Brett Johnson, PhD, International Cancer Advocacy Network
View Dr. Dolinar’s presentation. (Ensuring Patient Safety)
Read ASBM press release.
