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 Exhibits at APhA Annual Meeting
From March 22nd-24th, ASBM exhibited at the Annual Meeting of the American Pharmacists Association (APhA), held in Seattle, Washington. Founded in 1852, APhA is the largest association of pharmacists in the United States, with more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, and pharmacy technicians as members.
ASBM was represented at its booth by Advisory Board Chair Philip Schneider, past president of the American Society of Healthsystem Pharmacists (ASHP) and Advisory Board Member Ronald Jordan, Dean of the Chapman University College of Pharmacy and past president of APhA.
Dr. Schneider answered questions about biosimilar policy issues which affect pharmacy practice, including naming practices in the US and internationally. US biosimilar substitution policy, which varies by state, was also discussed.
Read more about ASBM’s APhA exhibit here.
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Mississippi Becomes 46th State to Enact Biosimilar Substitution
Legislation
On March 21st, Mississippi Governor Phil Bryant signed Senate Bill 2365, making Mississippi the 46th U.S. State to enact legislation permitting pharmacists to substitute a biosimilar once approved by the FDA as interchangeable.
The law requires pharmacists to communicate to the prescriber within 5 business days which product- the reference or the biosimilar- was dispensed. This ensures that all parties maintain an accurate patient record, that physicians can accurately assess a patients’s response to a particular treatment, and can make informed decisions. Physicians also retain the authority to prevent a substitution they deem medically inappropriate.
On February 6th, ASBM Chair Madelaine Feldman participated in a briefing for Mississippi legislators to discuss the bill.
Read about the legislation here.
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FDA Approves 18th Biosimilar, Fourth for Trastuzumab
On March 11th, the FDA granted approval to trastuzumab-qyyp (Trazimera), referencing trastuzumab (Herceptin). This is the fourth trastuzumab biosimilar approved in just 15 months. The first, trastuzumab-dkst (Ogiviri), was approved in December 2017.
Trastuzumab-qyyp is used to treat patients with HER-2 overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Read more about the approval here. |
FDA Releases Updated Draft Guidance on Biologic Naming
On March 7th, FDA released and updated Draft Guidance on the naming of biological products. According to the Guidance document, the FDA no longer intends to retroactively assign random 4-letter suffixes to existing biologics. The guidance states that the FDA will continue to assign suffixes to all new biologic products, innovator and biosimilar, as they are approved. Biosimilars which are later deemed interchangeable will retain their suffix.
ASBM released a statement is support of the updated guidance, which said in part:
ASBM commends the decision by FDA to apply distinguishable suffixes to all biologics, including interchangeable biosimilars going forward. FDA’s decision puts in place a protocol for a safe future, when there are many more biologics, biosimilars and interchangeable biosimilars.
The full statement may be read here.
The difficulties associated with applying distinguishing suffixes to previously-approved biologics were cited as a contributing factor to Health Canada’s recent decision not to harmonize nomenclature its with FDA’s system following extensive discussions.
However, the new guidance explains that the agency will continue to assign suffixes to newly approved innovator biologics, biosimilars, or interchangeable biosimilars. With regard to interchangeable biosimilars (those which can be substituted at the pharmacy level without physician involvement), the Agency made clear that an approved biosimilar’s suffix would not be changed should it subsequently be designated interchangeable.
Finally, FDA clarified its treatment of so-called “transition products”
including insulins, that were approved under the Section (505) of the Food, Drug and Cosmetic Act which will be deemed biosimilars as of March 23, 2020. These products also will not be renamed with new suffixes.
Read the full Guidance here.
Comments on the Guidance are due by May 7th and may be submitted here.
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| ASBM Meets with Health Canada, FDA and WHO to Discuss International Harmonization of Biologic Naming
On March 6th, 2019, ASBM hosted the third in a series of meetings with regulators to discussion the international harmonization of biologic nomenclature. Participants included representatives from Health Canada, the FDA, and the World Health Organization. Other participants included members of canadian physician and patient advocacy organizations from the disease states commonly treated with biologic medicines.
The meeting, held in Ottawa, Ontario served as a follow-up to prior meetings held during April and July in Washington, DC.
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.
Read more about the meeting here.
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| ASBM Chair Discusses Biosimilars Education
On March 1st, The first of a series of videos featuring ASBM Chair Madelaine Feldman, MD FACR was published by the Center for Biosimilars on their webiste, in which Dr. Feldman discusses prescriber persepctives on biosimilar education and interchangeability.
The video was recorded in January at the group’s New Jersey studios, at a forum comprised of pharmacists, clinicians, and representatives from biosimilar development companies.
Watch the video here.
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| UPCOMING ASBM EVENTS
Digestive Disease Week
San Diego, CA – May 18-21
BIO International Convention
Philadelphia, PA – June 3-5
DIA Annual Meeting
San Diego, CA – June 23-27
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