Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.
For media inquiries please contact: michael@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 971 – 1700
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| ASBM Chair Presents at ArthritisPower Patient Governor’s Summit
On October 6th, ASBM Chair Madelaine Feldman, MD, FACR, presented at the 5th annual ArthritisPower Patient Governors’ Summit in Phoenix, AZ. The Summit was presented by the Global Healthy Living Foundation, an ASBM Steering Committee Member.
Dr. Feldman’s presentation provided an overview of biologic medicines and biosimilars, and examined key biosimilar policy issues including naming, substitution, labeling, and non-medical switching. Dr. Feldman shared perspectives on these issues and discussed ASBM’s work in addressing them at the state, federal and international level.
View Dr. Feldman’s presentation here.
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| ASBM Presents to European Oncology Nurses at ESMO 2018
On October 19th, ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave a presentation to the European Oncology Nurses Society in Munich, Germany.
Mr. Spiegel’s presentation was entitled “A Patient Advocate’s Perspective on Biosimilar Medicines”, and was presented as a part of the European Society of Medical Oncology (ESMO) 2018 Congress.
The presentation reflected the excitement for biosimilars among the patient community, but emphasized the importance to patients of controlling their treatment decisions. Also important to patients was ensuring clear product identification with distinct naming for all biologics, including biosimilars; this helps ensure accurate attribution of adverse events to the correct product and avoid inappropriate or inadvertent subsitution.
View Mr. Spiegel’s presentation here.
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| ASBM Exhibits at ACR/ARHP Annual Meeting in Chicago
From October 21st- October 23rd, ASBM exhibited at the 2018 Annual Meeting of the American College of Rheumatology/Association of Rheumatology Healthcare Professionals, held in Chicago, IL. The conference was attended by more than 15,000 rheumatology health professionals from more than 100 countries.
ASBM Chair Madelaine Feldman, MD FACR and ASBM’s Immediate Past Chair Harry Gewanter, MD MACR both spent time at the ASBM booth in the patient pavilion, interacting with their fellow rheumatologists from the US and around the world. At the booth, ASBM distributed its new whitepaper on international harmonization of biologic nomenclature.
Dr. Feldman also led a session on increasing patient access to biologic medications, including the role Pharmacy Benefit Managers (PBMs) play. In her presentation, Dr. Feldman emphasized the importance of therapeutic choice remaining with patients and their clinicians; rather than with third parties such as PMBs, insurers, or government agencies.
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| ASBM/Scientific American Whitepaper Shows Strong Regulator Support for Distinct Naming, International Harmonization
A whitepaper released October 22nd by the Alliance for Safe Biologic Medicines calls on the World Health Organization (WHO) to implement a harmonized naming protocol for biologic medicines to help keep patients safe.
According to the paper, regulators, physicians, and patients are supportive of international harmonization of biologic names and are calling on the WHO to implement the proposed naming system so that it is available for regulators to use.
The paper is based on a roundtable discussion on international harmonization of biologic nomenclature held April 11th in Washington DC. Participants included representatives from the U.S. FDA and Health Canada, major physician and pharmacist societies, and patient advocates. The forum was sponsored by the Alliance for Safe Biologic Medicines (ASBM) and Scientific American, which prepared the paper.
Despite wide support for the BQ proposal outside of WHO as well – regulators support it by a 2-to-1 margin as do large majorities of surveyed physicians in the US (66%) and Canada (68%) Australia (79%) and in Latin America (94%) – WHO has not yet implemented the system its expert committee recommended.
Read the press release for the whitepaper here.
Read the whitepaper here.
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| ASBM Presents at 67th WHO INN Consultation
On October 23rd, ASBM Advisory Board Chair, Philip Schneider, MS, FASHP and Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, presented before the 67th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the eleventh INN Consultation at which ASBM has presented since 2013. Gail Attara, President and CEO of the Canada-based Gastrointestinal Society, an ASBM member, also presented.
While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary for the 66th INN Consultation may be viewed here.
ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. Sixty-six percent of U.S. physicians surveyed support distinct naming for all biologics including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.
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| ASBM Exhibits at DIA Annual Canadian Meeting
October 30th-31st, ASBM exhibited at the 2018 DIA Annual Canadian Meeting, held in Ottawa, ON. ASBM was represented by Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association.
Mr. Spiegel staffed ASBM’s booth, and spoke with attendees about ASBM’s work on the international harmonization of biologic nomenclature, including meetings with Health Canada, FDA, and WHO in Washington, DC during April and July.
ASBM’s recent whitepaper on the April meeting was made available at the booth, as was ASBM’s 2017 survey of 403 Canadian physicians on the biosimilar issues including naming and Non-Medical Switching.
Mr. Spiegel also discussed ASBM’s work in Canada on Non-Medical Switching, including as a part of the Canadian Biosimilars Working Group.
Read more about the Biosimilars Working Group here.
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| UPCOMING EVENTS
American Society of Health System Pharmacists Conference
Anaheim, CA – December 2-6
DIA Europe Meeting
Vienna, Austria – February 5, 2019
APhA Annual Meeting
Seattle, WA – March 22-25, 2019
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