March 6th, 2014
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.
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.
November 6th, 2013
On October 26, Dr. Richard Dolinar served as the keynote luncheon speaker at the National Association of Latino Elected and Appointed Officials (NALEO) Legislative Summit on Health in Las Vegas. Dr. Dolinar discussed the science and policy issues surrounding biosimilar provisions of the Patient Protection and Affordable Care Act with state legislators from across the country. He explained the differences between traditional chemical drugs and live biologics – stressing the fact that when attempting to replicate biologics, biosimilars, are similar to, but not exact versions of the biologic they aim to replicate and therefore they may act differently in the body.
Dr. Dolinar also gave background on the legislative battles states are facing and the need to prioritize patient safety as biosimilars are approved.
April 26th, 2013
On April 23, Michael Reilly participated in the Food and Drug Law Institute (FDLI) 2013 Annual Conference, speaking on a panel on the priorities and challenges facing the FDA and the Center for Biologics Evaluation and Research (CBER). Following presentations by CBER officials, Diane Maloney, Associate Director for Policy, and Mary Malarkey, director in the Office of Compliance and Biologics Quality, Michael led the panel discussion by giving brief remarks on the complex issues facing state legislators as they try to understand the differences between biosimilars and generics and why those differences have many physicians concerned if they are not informed by a pharmacist when a biosimilar is substituted for a prescribed biologic.
The panel was moderated by Scott Cunningham, a partner with Covington & Burling LLP and also included presentations from Brian Malkin, with Frommer, Lawrence & Haug LLP and Mark S. Robbins, PhD, with DiaMedica USA, Inc.
Read more here.
December 21st, 2012
On December 13th, ASBM members were invited to take a tour of a biologics manufacturing facility in Rhode Island to learn about the intricacies and complex processes involved with making biologic medicines.
December 21st, 2012
On December 6th, 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.
October 5th, 2012
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.
September 17th, 2012
On September 13, Dr. Dolinar presented on two panels at the DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA in Washington, D.C. His first panel was on Pharmacovigilance, Naming, and Labeling and the second panel was on Interchangeability.
During the conference, ASBM released a new survey examining physician practices and perspectives with regard to biosimilars and substitution.
Inappropriate substitution is a major risk if different biologics have the same scientific name.
Names are the primary means of product identification for physicians.
Physicians are very concerned about a patient being switched from one biologic to another.
View the ASBM Biosimilars Survey.
June 28th, 2012
On June 4, Alliance Chairman Dr. Richard Dolinar and Executive Director Michael Reilly presented at the Canadian Patient Experts in Health Technology forum in Toronto, Canada. The forum was organized by Durhane Wong-Rieger, president of the Canadian Organization for Rare Disorders. The two-day event was set up to establish a global network of individual patient experts and discuss pressing issues related to the access of drugs and health technology.
April 18th, 2012
On February 27, 2012, the Alliance for Safe Biologic Medicines and Bloomberg Government hosted a lunch time Biosimilars Forum on Capitol Hill to discuss the FDA’s draft guidance documents on biosimilar product development.
October 5th, 2011
By Kathy Feegal
Dr. Richard Dolinar, the Alliance’s chairman, was a keynote speaker at a biosimilars roundtable discussion in Boston, MA on October 5, 2011. The event was hosted by Northeastern University and was attended by numerous stakeholders from across New England, including the Massachusetts Medical Society, and patients groups such as the National Kidney Foundation; American Cancer Society; AIDS Action; as well as elected officials and policymakers from the state legislature.