Recent Events
FDLI Annual Conference
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.
ASBM Forum in Rhode Island
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.
Biosimilars Forum in Colorado
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.
Phoenix Forum
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.
DIA/FDA Conference on Biosimilars
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.
DIA Presentation on Biosimilar Naming
DIA Presentation on Interchangeability
During the conference, ASBM released a new survey examining physician practices and perspectives with regard to biosimilars and substitution.
Results showed:
Inappropriate substitution is a major risk if different biologics have the same scientific name.
- 64 percent of surveyed physicians assume if products have the same name a patient can be safely switched from one product to another during treatment.
- More than 76 percent view products with the same scientific name as structurally identical.
Names are the primary means of product identification for physicians.
- The vast majority (99 percent) of physicians refer to biologic medicines by name for both recording in charts and for reporting adverse events.
- Less than 1 percent of prescribers use national drug code numbers for records or reporting.
Physicians are very concerned about a patient being switched from one biologic to another.
- 85 percent of responding physicians want the authority to designate a biologic medicine as “Dispensed as Written”, just as they have it for chemical products.
- 86 percent of physicians want to be notified BEFORE a patient is switched to a biologic other than the one prescribed EVEN IF there are no known concerns associated with the product.
View the ASBM Biosimilars Survey.
ASBM Presents in Toronto, Canada
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.
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Alliance for Safe Biologic Medicines – Capitol Hill Biosimilars Forum, Washington, D.C.
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.
Alliance’s Dolinar Headlines Boston Biosimilars Event
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.
Biologics and Biosimilars: What Patients, Physicians and Advocates Need to Know Access, Patient Safety and Emerging Policy Issues
September 28th, 2011
The Alliance for Safe Biologic Medicines joined with the Virginia Biotechnology Association at an event to expore with patients, advocates, physicians and other healthcare providers the importance of maintaining patient safety as the U.S. FDA’s top priority while it works to establish a pathway for approval for biosimilar products.
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Biosimilars Policy Forum
August 17th, 2011
The Alliance for Safe Biologic Medicines and Pennsylvania Bio hosted an event entitled, “Biosimilars Policy Forum: Ensuring Patient Safety” in Philadelphia, PA, on August 17, 2011
The purpose of the forum discussion was to explore with community members, including policymakers, patients, physicians, pharmacists, and hospital officials the importance of maintaining patient safety as the U.S. Food and Drug Administration’s top priority while it works to establish an approval pathway for biosimilar products.
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