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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| ASBM Chair Participates in Webinar on Patient Access
On November 21st, ASBM Chair Madelaine Feldman, MD, FACR participated in a webinar hosted by the Patient Access Collaborative, to discuss the topic of utilization management (UM) techniques employed by third-party payers.
UM techniques include formulary constructions and other practices intended to reduce health plan or pharmaceutical benefit manager (PBM) spending on medications including biologic medicines, or which otherwise restrict patients’ access to these medications by requiring additional permissions, forms, and/or medicines.
These tools, as Dr. Feldman explained, can interfere with the practice of medicine and limit patient access to preferred treatments. They also create an administrative burden for provider offices that require significant resources to fulfill payer requirements on behalf of patients.
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| FDA Approves 25th Biosimilar, Its 9th Approval this Year
On November 15th, Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, released a statement regarding the FDA’s great progress in biosimilar approvals since its first approval four and a half years ago in March 2015. From the statement:
Today the FDA took another step to further foster biologics competition with the approval of Abrilada (adalimumab – afzb), a biosimilar to Humira. Today’s approval is one of nine new biosimilar products the FDA has taken action on in 2019, bringing the overall total of biosimilar approvals to 25. I’m pleased to see this progress and am confident that the market for these therapies will continue to grow. To date, 74 programs for 38 different reference products have been enrolled in our Biosimilar Product Development Program to discuss development of proposed biosimilar products or interchangeable products, laying the foundation for ongoing competition in the marketplace.
Read the full statement here.
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ASBM Chair at Healio.com: PBM Rebate System “Perfectly Legal, Perfectly Wrong”
A November 19th op-ed by ASBM Chair Madelaine Feldman, MD, FACR sheds some light on a major commercial barrier to biosimilar uptake, one in which paradoxically, competition often means higher, rather than lower drug prices: the Pharmaceutical Benefit Manager (PBM) rebate system:
[PBMs] create the formularies that determine what drugs will be paid for, when they can be taken, where they can be purchased and how much they will cost the patient. Obviously, this becomes very important for our expensive rheumatologic medications because, if an expensive medicine is not on the formulary, it is completely unaffordable for patients.
To get the coveted “preferred” status on the formulary, manufacturers send in secret kickback package bids to the PBMs. The highest kickback package amount wins the prize of “preferred” status, meaning patients must step through the winner’s drug before taking the less preferred drugs. This gives automatic market share to the winning kickback package bidder.
The greater the market share and the number of indications a drug has, the more leverage that manufacturer has to control the formulary…It is easy to see that the higher the price of your drug, the better your kickback package looks to the PBM. Remember that competition in this system raises prices, just like at an art auction when everyone is bidding on that same coveted work of art.
Read the entire op-ed here.
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| ASBM Exhibits at ACR/ARP Annual Meeting
From November 10-12, ASBM exhibited at the ACR/ARP Annual Meeting in Atlanta, Georgia. Nearly 16,000 rheumatologists, rheumatology health professionals, fellows-in-training, and exhibitors from more than 100 countries attended the event. ASBM was represented at the meeting by Chair Madelaine Feldman, MD, FACR; Immediate Past Chair Harry Gewanter, MD MACR; and Executive Director Michael Reilly, each of whom spent time at ASBM’s booth and met with conference attendees.
At ASBM’s booth literature was distributed which covered many key biosimilar policy issues which affect rheumatology practice. These included data showing strong support among U.S. physicians for FDA’s recent policy update on biologic naming, a fact sheet discussing what can be learned from the European biosimilar substitution experience, the abstract for ASBM’s forthcoming GaBI Journal whitepaper on features of European biosimilar markets that contribute to their famously high uptake levels, and a poster recently shared at the ESMO conference in Barcelona which featured findings from ASBM’s recent survey of 579 European physicians.
Read more about the ACR Annual Meeting here.
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| First Rituximab Biosimilar in U.S. Launches at 10% Discount
On November 7th, biosimilar manufacturers Teva and Celltrion announced that Truxima (rituximab-abbs), the first biosimilar to Genentech’s Rituxan (rituximab), will be available in the U.S. starting November 11th. The biosimilar sells at a 10% discount over the originator product.
Like its reference product, Truxima is currently indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).
Read more about the approval here.
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| ASBM Exhibits at DIA Annual Canadian Meeting
On November 5th and 6th, ASBM exhibited at the (Drug Information Association (DIA) Annual Canadian Meeting, a meeting of Canadian regulators, researchers, health professionals and pharmaceutical manufacturers.
Held in Gatineau, Quebec, just outside the Canadian capital of Ottawa, the meeting’s purpose is to present a comprehensive overview of the current bio-pharma and device landscape in Canada, while sharing insights into Canada’s broader role in global healthcare product development. Session topics included the patient experience, international collaboration, and the use of real-world evidence in safety and efficacy monitoring.
ASBM was represented at the conference by Advisory Board Chair Philip Schneider, MS FASHP FFIP. At ASBM’s booth, Schneider met with conference attendees, including several Health Canada officials, to discuss ASBM’s work. Policy issues discussed included the importance of distinct biologic nomenclature in pharmacovigilance, efforts toward international harmonization of biologic nomenclature, and emerging biosimilar substitution policies in Canada.
ASBM also used the meeting as an opportunity to discuss potential lessons that could be learned from European countries. While some Canadian provinces have adopted or are considering forced biosimilar subsitution European countries enjoy high biosimilar uptake rates and have overwhelmingly rejected such policies.
While at DIA Canada, ASBM released the abstract of a forthcoming whitepaper on the European biosimilars experience, co-authored by Dr. Schneider and ASBM executive director Michael Reilly.
The paper examines the policies which led to Europe’s success- including preserving physician choice and promoting competition between multiple products:
“Due to its global leadership in biosimilar regulation and approvals, the biosimilar market in Europe has been the largest market to date, representing approximately 60% of the global biosimilar market and growing consistently year over year. As a result, European countries with their diverse healthcare systems and their experience to date serve as real world examples of different approaches of biosimilar policies to build an efficient and sustainable biosimilar market and thus offer an opportunity for other countries to learn and to avoid mistakes which may put short but in particular long-term savings at risk.”
The abstract was available at the ASBM booth, as was a new fact sheet, entitled “What Can Canada Learn From the European Biosimilar Experience?”, which incorporates findings from the whitepaper, data from ASBM’s recent survey of 579 European physicians, and the perspectives of Canadian physicians and patient advocacy organizations on substitution policy.
View the fact sheet here.
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UPCOMING EVENTS
Festival of Biologics USA
San Diego, CA – March 2-4, 2020
DIA European Meeting 2020
Brussels, Belgium – March 17-19, 2020
American Society of Clincial Oncology (ASCO) Annual Meeting
Chicago – May 29 -June 2, 2020
EULAR European Congress of Rheumatology 2020
Frankfurt, Germany – June 3-6, 2020
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