On February 25, ASBM held a forum to educate patient advocates, physician groups and members of its International Advisory Board on the complex issues related to biosimilars.
The half-day forum entitled, “Ensuring Access to Safe Biosimilars: Policy Developments and Emerging Challenges” focused on the challenges facing world regulators including the U.S. Food and Drug Administration (FDA), the importance of distinguishable non-proprietary names for biosimilars and the value of and need for patient, physician and pharmacist education on issues related to biosimilars.
INTRODUCTORY VIDEO ON BIOSIMILARS
Following opening remarks by ASBM Chairman Richard Dolinar, MD, this seven-minute video was shown, setting the stage for the day’s presentations and panels by answering some fundamental questions about biologic medicines: What are biologics? How do they help patients? How do they differ from chemical drugs? What are biosimilars? And what unique challenges do they present for regulators and policymakers?
PRESENTATION: ASBM ACTIVITY, 2011-2014
Michael S. Reilly, ASBM Executive Director
ASBM Executive Director Michael S. Reilly reviews the regulatory history of biosimilars in the U.S., beginning with the Affordable Care Act’s creation of a biosimilar pathway, and the formation of ASBM in late 2010 as a means of offering guidance to FDA from a diverse group of patients, physicians, researchers, and industry stakeholders. Mr. Reilly outlines major projects of ASBM over the past few years and tracks its evolution from a primarily domestic advocacy group, into a voice for global standards governing the safety, efficacy, approval, and naming of biosimilars.
PRESENTATION: THE VALUE OF PATIENT ADVOCACY
Andrew Spiegel, ASBM Steering Committee Member and Co-executive Director of the Global Colon Cancer Association
Mr. Spiegel discusses the value of patient advocacy, highlighting how ASBM has benefitted patients. Mr. Spiegel details his experience as a patient advocate including his work with patient groups around the world, and his advocacy to policymakers throughout the U.S. This presentation set the stage for the subsequent panel discussion featuring Mr. Spiegel, Marcia Horn, President of the International Cancer Advocacy Network, and Joseph Jefferson, Director of Advocacy and Alliance Development at HealthHIV. Brian Rye, Health Policy Analyst at Bloomberg Government, moderated the discussion.
PRESENTATION: REGULATORY CHALLENGES FOR THE FDA
Dirk Reitsma, MD, ASBM Advisory Board Member
As the U.S. biosimilar pathway evolves, FDA continues to develop its guidance for biosimilar manufacturers, including what type of data a manufacturer will need to provide for a biosimilar to be determined as ‘interchangeable’, how clinical trials will need to be designed, and how well-understood the biosimilar’s mechanism of action must be to ensure quality and safety. ASBM International Advisory Board Member and oncology researcher Dirk Reitsma, MD gives a regulatory update and offers his thoughts on how current regulatory regimes in existence around the world may, or may not, impact FDA’s upcoming regulation.
PRESENTATION: DEVELOPING INTERNATIONAL REGULATORY STANDARDS FOR BIOSIMILARS
Kirsten Vadheim, PhD
Approval of any medicine for patient use requires safety and efficacy data over time, to minimize the incidence of adverse events. In this presentation, former FDA regulator Kirsten Vadheim underscores the importance of these high standards for biologics in particular, due to their complexity and extreme sensitivity to minor manufacturing differences. Also examined are the efforts of several organizations around the world, including the World Health Organization (WHO) to build a shared, international framework of regulatory standards for biosimilars.
PANEL DISCUSSION: A COLLABORATIVE APPROACH TO PHARMACOVIGILANCE
Richard Dolinar, MD, ASBM Chairman view presentation
Phil Schneider, Associate Dean, University of Arizona College of Pharmacy view presentation
Under what circumstances may a biosimilar be substituted for its reference biologic, either by a pharmacist, insurer, or another third party? What type of communication and record-keeping must occur between prescriber and pharmacist to ensure good tracking and tracing of adverse events? These are the questions with which many state lawmakers are grappling, as biosimilar substitution legislation is debated across the U.S.
In conjunction with a panel discussion moderated by Brian Rye of Bloomberg Government, ASBM Chairman Richard Dolinar, MD presented the physician’s perspective on biosimilar substitution, along with a brief legislative review and update about an increasingly more collaborative approach to biosimilar legislation.
ASBM International Advisory Board Member and Associate Dean of the University of Arizona College of Pharmacy Phil Schneider in turn offers the pharmacist’s perspective, highlighting the common ground between physician and pharmacist, and areas where communication and cooperation could be improved.