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 to Meet with Health Canada and FDA to Discuss International Harmonization of Biologic Naming
On March 6th, 2019, ASBM will host the third in a series of meetings with regulators to discussion the international harmonization of biologic nomenclature. Participants will include representatives from Health Canada and the FDA.
The meeting, to be held in Ottawa, Ontario will serve as a follow-up to prior meetings held during April and July in Washington, DC. In addition to the regulators, participants will include members of leading physician and pharmacist societies, and patient advocates from the disease states commonly treated with biologic medicines.
The April 11th meeting was the subject of a recent whitepaper prepared by Scientific American, which co-hosted the meeting.
Read more about the whitepaper here.
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| Danish Biosimilar Switching Study Shows Patient Variability
In January a biosimilar switching study appeared in the journal Annals of Rheumatologic Diseases (ARD), published by the European League Against Rhematism (EULAR).
The study which examines the results of a mandated switch from orginator etanercept to a biosimilar among Danish patients with rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. It is an observational switching study of more than 2000 patients that compared switchers, non-switchers, back-switchers with each other and a historical cohort.
Its findings demonstrate the safety of the biosimilar as well as variability in patient response, with patient characteristics and disease state influncing outcomes more than any noted drug effects. These observations highlight the importance of physician and patient control of treatment decisions.
Read the study here.
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| FDA Approves 16th Biosimilar, Third for Trastuzumab
On January 18, the FDA approved Onzutrant (trastuzumab-dttb) for three cancer indications. It is the third biosimilar to trastuzumab, and the 16th biosimilar approved by the FDA since approving its first less than 4 years ago.
Like its reference product, trastuzumab-dttb it is used to treat breast and gastric cancers. Ontruzant was approved in 2017 by the European Medicines Agency for use in the EU.
The approval comes just one month after the FDA’s approval of its second trastuzumab biosimilar, Herzuma (trastuzumab-pkrb) for breast cancer indications in December 2018.
Read more about the approval here.
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| ASBM Chair Interviewed on Biosimilars Education
On January 7th, ASBM Chair Madelaine Feldman, MD FACR was interviewed by the Center for Biosimilars at a forum comprised pharmacists, clinicians, and representatives from biosimilar development companies. The topic was education on biosimilars. Dr Gillian Woollett of Avalere Health moderated the discussion, which was recorded at the group’s studio in New Jersey.
Clips from the interview may be viewed here throughout the month of March.
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UPCOMING ASBM EVENTS
International Naming Harmonization Forum
Ottawa, ON – March 6
APhA Annual Meeting
Seattle, WA – March 22-25
67th WHO INN Consultation
Geneva, Switzerland – April 2-5
BIO International Convention
Philadelphia, PA – June 3-5
DIA Annual Meeting
San Diego, CA – June 23-27
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