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: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
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Physicians, Patients Express Overwhelming Support for FDA Distinct Biologic Naming Plan
US physicians and patient advocacy organizations expressed their overwhelming support for the FDA’s suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency.
Biologic medicines treat serious conditions including rheumatoid arthritis, psoriasis, and cancer. Lower-cost versions, called biosimilars, offer new therapeutic choices but unlike generics are not exact copies of the originator. These inherent differences spurred the FDA to implement a system of distinct suffixes to ensure clear product identification; the comment period on a recent update to the policy closed May 7th.
Support for the recent update to the FDA policy was very strong and diverse. A joint letter of support was submitted by physician organizations including 24 national and state rheumatology associations and Harvard Medical School.
ASBM was among the more than 100 patient advocacy organizations that submitted comments or signed on to letters of support for the policy, as did 124 individual patients, nurses, and other health care providers. A letter of support was also submitted from two past presidents of the American Pharmacists Association and the American Society of Health-system Pharmacists.
In addition to the submitted comments, results from a May 2019 survey of 202 biologic prescribers were shared with FDA; in which 85% said they “strongly agree” or “somewhat agree” with the FDA’s policy of adding 4-letter suffixes. Only 7% strongly or somewhat disagree with the policy, while 8% were “unsure”.
Physicians were strongly supportive of recent updates to the FDA policy, including the decision not to retrospectively rename previously approved products with suffixes: 71% agreed with the FDA’s decision not to rename previously-approved biologics with suffixes, and 67% agreed with the FDA’s decision not to rename insulin, desirudin, and somatropin products previously approved under the Food Drug and Cosmetics Act.
Respondents were drawn equally from specialties in which biologics are routinely prescribed, including rheumatology, gastroenterology, endocrinology, oncology, dermatology, neurology, immunology,
nephrology, and ophthalmology.
Read ASBM’s press release and about the comments and survey here.
The full survey may be viewed here.
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FDA Finalizes Interchangeability Guidance
This month, the FDA finalized its guidance on the pathway for interchangeable biologics, which may be substituted without the involvement of the prescriber. From a statement by Acting FDA Commissioner Norman E. Sharpless, MD:
Today’s final guidance gives an overview of important scientific considerations in demonstrating interchangeability with a reference product and explains the scientific recommendations for an application or a supplement for a proposed interchangeable product. Once an application or supplement seeking licensure as an interchangeable product is submitted, the FDA will approve the biological product as interchangeable with the reference product if the information submitted in the application or the supplement is sufficient to meet the applicable statutory standard: among other things, that the biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient. The guidance also explains potential ways to address the BPCI Act requirement for interchangeability that, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product will not be greater than the risk of using the reference product without such alternation or switch.
Read the full FDA Statement here and the Final Guidance here. |
| FDA Approves 19th Biosimilar, Second for Etanercept
In late April, FDA approved Eticovo (etanercept-ykro), the second biosimilar for etanercept.
Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.
Eticovo has been approved across all eligible indications, namely ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis and rheumatoid arthritis.
Read more about the FDA approval here.
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| ASBM Presents at 68th WHO INN Consultation
On April 2nd, ASBM Chair Madelaine Feldman, MD, FACR; and Advisory Board Chair, Philip Schneider, MS, FASHP presented before the 68th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the twelfth INN Consultation at which ASBM has presented since 2013.
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 67th 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.
In the past year, ASBM has held three meetings to discuss international harmonization of biologic nomenclature. Participants included representatives from the FDA, Health Canada, the WHO, physician and pharmacist societies, and patient advocacy organizations. The first two meetings took place in April and July 2018 in Washington, DC, and the third in March 2019 in Ottawa, Ontario. A white paper on the first of these meetings may be read 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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