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 Testifies Before Nebraska Senate
On February 2nd, ASBM Chairman Harry Gewanter, MD testified before the Senate Health Committee in support of LB 481 along with two patients representing the Arthritis Foundation. Like similar bills which have been enacted in 26 states and Puerto Rico, LB 481 would permit pharmacists to substitute interchangeable biosimilars for a prescribed biologic. The legislation allows automatic substitution of a prescribed biologic provided the pharmacist communicates which medicine was ultimately dispensed to the patient. In addition, LB 481 ensures that the physician has the authority to prevent a substitution they deem medically inappropriate by writing “dispense as written”.
No opposition to the bill was submitted, and the Nebraska Pharmacist Association joined numerous patient groups and the Nebraska Medical Association in sending in a letter of support.
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ASBM Advisory Board Chair Briefs Kansas Legislators, Testifies in Support of Biosimilars Bill
On January 24th, ASBM Advisory Board Chair Philip Schneider participated in a briefing for 25 Kansas state legislators, patients, and others regarding HB 2107. ASBM had submitted a letter of support for the bill the previous day, which may be read here.
Stephen Marmaras from Global Healthy Living Foundation, an ASBM Steering Committee Member, presented the patient perspective on biosimilar substitution, discussing the benefits biosimilars will bring to patients and the cost savings that could be realized once they are widely available. He also highlighted the need for transparency so that both patients and their physicians know which medicine they receive.
ASBM’s Advisory Board Chair Philip Schneider followed Mr. Marmaras with a presentation on the pharmacist perspective. Dr. Schneider emphasized the importance of good communication and collaboration between healthcare providers, and discussed the evolution of biosimilar substitution bills nationally so as to not place undue burden on pharmacists. View Dr. Schneider’s presentation here.
Later that day, Dr. Schneider testified before the Kansas House Health and Human Services Committee in support of HB 2107. His testimony read, in part:
“Because biologic products differ from generics in complexity and are not identical chemical products, [HB 2107] ensures there will be clear and timely communication between pharmacists and prescribers to ensure medical records reflect which specific product has been dispensed to the patient…Having an accurate patient record allows providers to assess the patient’s response to a particular treatment, including proper attribution of any adverse events to the correct product, and helps us make informed treatment decisions.”
Read Dr. Schneider’s full testimony in support of HB 2107 here.
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FDA Releases Draft Interchangeability Guidance
On January 17th, the FDA released long-awaited Draft Guidance on Interchangeability. Interchangeable biosimilars are those biosimilars which can be substituted in place of their reference product at the pharmacy without physician involvement. Switching to an interchangeable biosimilar must be expected to produce the same clinical results as staying on the reference product, without bringing any additional risks.
In the Draft Guidance the FDA has proposed that a biosimilar should undergo three successful switches (reference to biosimilar, biosimilar back to reference, reference back to biosimilar) providing at least 2 exposure periods to each product, to demonstrate interchangeability. This will serve to build physician and patient confidence in biosimilars.
ASBM will continue to review the Draft Guidance and will submit comments to the FDA. The deadline for comments is March 20th.
The Guidance may be read here.
Comments on the Draft Guidance may be submitted here.
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FDA Finalizes Naming Guidance
On January 12th, the FDA finalized its Guidance on Naming of Biological Products. As in the Draft Guidance, the FDA has chosen to distinguish biologics and biosimilars from one another via four-letter suffixes devoid of meaning. Yet this remains at odds with the preferences of the physicians who prescribe biologics and the pharmacists who dispense them, as revealed in two 2015 ASBM surveys.
When 400 U.S. biologic prescribers were asked their preference between manufacturer-based suffix such as “sndz” used in Zarxio (filgrastim-sndz), where “sndz” reflects the manufacturer, Sandoz) and random suffixes such as “bflm” (the proposed replacement of “-sndz”), 60% of prescribers preferred the manufacturer-based format. (9% preferred random, and 32% had no opinion.) Among the 401 pharmacists surveyed by ASBM, this preference for meaningful, memorable suffixes was even stronger: 77% preferred the manufacturer-based suffix, 15% the random suffix, and 8% had no opinion.
Read ASBM’s statement on the Naming Guidance here.
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STATE SUBSTITUTION BILL ACTIVITY
Arkansas HB1204 Introduced 1/18/17; referred to Senate Committee on Public Health, Welfare and Labor.
Alaska SB 32 Read ASBM’s letter of support here.
Iowa: Study bills HSB38 and SSB1029 (same language) introduced. Health Subcomittee meeting scheduled for 2/2 cancelled.
Kansas HB 2107– ASBM Advisory Board Chair Philip Schneider testified in support before Senate Health and Human Service Cmte on 1/24. Opponents testified 1/26. Read ASBM’s letter of support here.
Montana HB 233 passed House 100-1 on 2/1. Senate Cmte Hearing scheduled 2/8.
Nebraska- LB 481 ASBM Chairman Harry Gewanter MD testified in support 2/2 before Sen. Health Cmte. Read ASBM and Nebraska Pharmacist Association letters of support.
New Mexico HB 260 and SB 180 (identical bills) introduced 1/25; referred to House Business and Industry Cmte and Senate Public Affairs Cmte.
South Carolina– HB 3438 and SB 299 (identical bills) introduced 1/12. Referred to House Cmte on Medical, Military, Public and Municipal Affairs, and Senate Cmte on Medical Affairs, respectively.
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UPCOMING BIOSIMILAR EVENTS
Biosimilars & Follow-On Biologics 2017 Americas
Philadelphia, PA – March 20-22, 2017
29th Annual DIA EuroMeeting
Glasgow, Scotland – March 29-31, 2017
WHO 64th INN Consultation
Geneva, Switzerland – April 4, 2017
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