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
Follow Us
Twitter: @SafeBiologics
Facebook
LinkedIn
YouTube |
|
|
| GaBI Journal Publishes Abstract of ASBM’s Forthcoming Whitepaper on European Biosimilar Market
On October 30th, the Journal of the Generics and Biosimilar Initiative (GaBI Journal) published the abstract of ASBM’s forthcoming whitepaper on the evolution of the European biosimilar market. The whitepaper, co-authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider, will be published in the next issue of Gabi Journal. From the abstract:
“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.”
In the vast majority of European countries, the payer reimburses multiple products, including the originator. This ensures a sustainable biosimilar market with multiple suppliers competing in a given product class. Even in Norway with its national tender system, physicians retain the option to prescribe any of the available products but are strongly encouraged to choose the lowest priced product, in particular for newly treated patients.
Mr. Reilly expressed his hope that the white paper will serve as an educational resource for countries outside of Europe seeking to build robust and sustainable biosimilars programs and policies for their patients that are similar to those found across European Union Member States.
Read the abstract of the forthcoming whitepaper here.
|
| ASBM Participates in European Commission Biosimilars Meeting
On October 30th, ASBM participated in the fifth annual “Stakeholder Event on Biosimilar Medicinal Products” held in Brussels, Belgium.
The day-long multi-stakeholder event was organized by the European Commission and the European Medicines Agency (EMA).
Participants included representatives of public authorities, patients’ organizations, healthcare professionals, and pharmaceutical companies. They shared their best practices and clinical experiences with biological medicines, including biosimilars.
Topics included the uptake of biosimilars in oncology, sustainable procurement practices, and how to improve the understanding of biosimilars.
Read more about the Stakeholder Event here.
|
ASBM Presents to WHO, Urging Action on International Harmonization of Biologic Naming
On October 22nd, ASBM presented at the World Health Organization’s (WHO’s) 69th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the thirteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.
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 from the 68th INN Consultation – held on April 2, 2019 and in which ASBM also participated – may be viewed here.
Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings on this topic with FDA, Health Canada, and the WHO. Dr. Schneider also gave a presentation on the value of distinct biologic naming and the status of harmonization efforts at the DIA Global Annual Meeting in June.
Read more about ASBM’s work on international harmonization of global nomenclature here.
|
| ASBM Fact Sheet: What Can Canada Learn from the European Biosimilar Experience?
On October 28th, ASBM posted a fact sheet entitled “What Can Canada Learn from the European Biosimilar Experience?” to serve as a resource as Canadian provinces, including British Columbia and Alberta, look to duplicate Europe’s success with biosimilars.
The undisputed global leader in biosimilars with more than 60 products approved and the largest biosimilar market in the world, Europe has achieved impressive biosimilar uptake rates. These can be as high as 91% for older products (before the approval of the first monoclonal antibody biosimilar in 2013) and up to 43% for newer products (approved post-2013).
The fact sheet contrasts the principles that Europe has embraced- which include preserving physician/patient choice, promoting competition between multiple products, and prohibiting automatic substitution- with the forced-switching policy announced by the government of British Columbia:
B.C. Health Minister Adrian Dix cited Europe’s high biosimilar uptake rates as a justification for the [forced-switching] policy, but disregards the path and principles that led to this success.
It was not accomplished through a reimbursement ban on originator biologics, i.e., the limitation of medicine choice and resulting forced switching mandates, but through preserving choice for physicians and patient and promoting ongoing competition between all approved products based on many factors including cost, clinical evidence, delivery mechanism, patient history, and other factors.
Not only does the B.C policy have no analogue among Western European countries, it is built upon principles Europe has overwhelmingly rejected.
The fact sheet also reflects concerns raised with the BC policy by Canadian physicians and patient advocates. In addition, it includes data from ASBM’s 2017 survey of Canadian physicians, showing strong opposition to the third-party switching of stable patients for non-medical (e.g. cost) reasons, as happens under the B.C. policy.
View the fact sheet here.
|
| ASBM Presents at Biosimilar World Congress: Europe 2019
On October 15th and 16th, ASBM participated in the Biosimilar World Congress: Europe 2019, part of the three-day Festival of Biologics held in Basel, Switzerland. ASBM was represented at the conference by Advisory Board Chair Philip Schneider and Steering Committee member Andrew Spiegel, executive director of the Global Colon Cancer Association.
On the first day, Dr. Schneider participated in a panel entitiled “Increasing Global Patient Access to Biosimilars”. In his presentation, Dr. Schneider emphasized the role that clinicians, including physicians and pharmacists, can play as “learned intermediaries” who can balance patient-specific factors against the objectives of the pharmaceutical industry and of regulators.
Robust pharmacovigilance is also important to increase biosimilar confidence and uptake, said Schneider:
“With the reliance on analytics over clinical trials for market approval there is a need for real-world evidence, including strong pharmacovigilance programs. There is general agreement that these programs are not sufficiently strong, including in Europe. This would support the need for a common language with which we communicate clinical experience with biologics and biosimilars – for example, a global system of distinguishable non-proprietary names, as the WHO has proposed.”
On day two, Andrew Spiegel participated in a panel entitled “Stakeholder Collaboration for Biosimilar Sustainability”. In the discussion, Mr. Spiegel emphasized the importance of education to increase physician familiarity and comfort, but also highlighted the importance of not bypassing or excluding the physician from treatment decisions.
Spiegel cited the example of British Columbia, whose Health Minister cited Europe’s high uptake rates, yet pushed policies that Europe largely rejects. These include forced biosimilar substitution, third-party switching of stable patients for non-medical reasons, and elimination of reimbursement of an originator biologic by government fiat.
Mr. Spiegel emphasized that most European countries enjoy high biosimilar rates while preserving physician autonomy. Most European countries do not allow automatic substitution, and reimburse for whichever among multiple products the physician prescribes, including the originator. Only Denmark reimburses only the winning product, following a transparent national tender process. Norway also has a national tender, but allows physicians to prescribe- and continues to reimburse- innovator products.
Read more about ASBM’s participation in the conference here.
|
| UPCOMING EVENTS
ASHP Midyear Clinical Meeting
Las Vegas, NV – December 8-12, 2019
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
|
|
|
