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 to Present at Virtual Conferences in June
During the month of June, ASBM will be participating in three virtual conferences. We encourage all our members to visit the websites of these virtual conferences.
EULAR E-Congress (From June 3)
ASBM will present a poster abstract entitled “European Prescribers’ Perspectives on Biosimilars”. Data is drawn from ASBM’s 2019 survey of Rheumatologists in France, Germany, Italy, Spain, Switzerland, and the UK. Topics will include physician attitudes on prescribing biosimilars, non-medical switching, and design of government tenders.
More info here.
BIO Digital (June 8-12)
As part of BIO Digital’s Virtual Patient Advocacy Pavillion, ASBM will share educational literature on key biosimilar policy issues including non-medical switching and automatic substitution; physician survey data, and recent whitepapers including “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, appearing in in the June issue of GaBI Journal.
Learn more here.
DIA Global Meeting (June 14-18)
ASBM will present a poster abstract entitled “European Physician Perspectives on Biosimilars”, drawn from a 2019 survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries. This is the first time the full survey findings will be made publicly available.
Learn more about the DIA Global Meeting here.
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| Tufts Study: Lack of Preferred Coverage May be Hurting Biosimilars
On May 19th, a study was published in the Journal of the American Medical Association (JAMA) entitled “Coverage for Biosimilars vs Reference Products Among US Commercial Health Plans”. The study was conducted by investigators from the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center in Boston, Massachusetts. They evaluated 535 coverage decisions for biosimilars available in the United States in August 2019.
The study found that US health plans granted preferred status to biosimilars in just 14% of coverage decisions, according to a survey of decisions issued by 17 of the largest US commercial health plans, representing approximately 60% of commercially covered patients. By contrast, the reference product was given preferred status in 33% of decisions, and in 53% of decisions, neither the biosimilar nor the reference product was preferred.
“The slow uptake of biosimilars in the US has been attributed to factors such as patent disputes and reference product manufacturer tactics to delay biosimilar market entry. This study suggests that a lack of preferred coverage among health plans may also be delaying uptake”, said the study authors.
Read the study here.
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| ASBM Surveys of Physician Perspectives on Biosimilars Included in Systemic Review
On May 5th, the British Medical Journal (BMJ) published a review of numerous surveys and studies examining physician attitudes toward biosimilars, entitled “Physicians’ perceptions of the uptake of biosimilars: a systematic review” Of 331 unique studies examined, only 23 met the quality assessment of two independent researchers for inclusion. Among these were several physician surveys conducted by ASBM. Most of the selected studies were conducted in Europe and commonly used short surveys. Key findings included:
- Physicians’ familiarity with biosimilars varied: 49%–76% were familiar with biosimilars while 2%–25% did not know what biosimilars were, the percentages varying from study to study. Their measured knowledge was generally more limited compared with their self-assessed knowledge.
- Physicians’ perceptions of biosimilars also varied: 54%–94% were confident prescribing biosimilars, while 65%–67% had concerns regarding these medicines.
- Physicians seemed to prefer originator products to biosimilars for stable patients and prescribed biosimilars mainly for biologic-naive patients.
- They considered cost savings and the lower price compared with the originator biologic medicine as the main advantages of biosimilars
- Their doubts about biosimilars were often related to safety, efficacy and immunogenicity.
- 64%–95% of physicians had negative perceptions of pharmacist-led substitution of biologic medicines.
Read the full study review and analysis here.
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Gastroenterologists: More Evidence Needed Before Non-Medical Switching of IBD Patients
On April 27th, the journal Digesitve Diseases and Sciences published a editorial by Frank I. Scott, MD entitled “Infliximab Versus Biosimilars for IBD: Is It Better to Fight Than Switch?. Dr. Scott heads the Crohn’s and Colitis Center, Division of Gastroenterology and Hepatology, Department of Medicine, at the University of Colorado.
In the editorial, Dr. Scott discusses a study appearing in the April issue of Digestive Diseases and Sciences which presents the most comprehensive review to date of data supporting non-medical switching between infliximab and CT-P13 (marketed as Inflectra).
Forty-nine randomized controlled trials, observational studies, and conference abstracts were included in the authors’ review. Of these, only three of the reviewed studies were randomized controlled trials, including NOR-SWITCH and two as-yet-unpublished IBD-specific trials. From the article:
Collectively, these studies demonstrated no significant difference in sustained clinical response between bio-originator infliximab and its biosimilars.
Despite these reassurances, significant questions remain regarding the long-term safety of non-medical switching strategies. While the summarized data in their review, for the most part, suggest that switching between bio-originator infliximab and CT-P13 is safe, the data quality is limited. As noted previously, only one randomized controlled trial has been published, with two additional studies included which are pending publication. Significant heterogeneity among existing observational studies limits their interpretation as well. Further, while non-medical switching policies have been enacted, there has been incomplete pharmacovigilance reporting on the patient level and pharmacoepidemiologic evaluation at the population level. Lastly, since the available data pertain to single switches from originator compound to CT-P13, they incompletely reflect the multi-directional switching that may occur in practice with non-medical switching.
Unfortunately, loss of response to therapies in both CD and UC is well described, obscuring the differentiation of loss of response due to expected rates versus that which can be attributed to the switch itself. Accurately measuring this risk will be vital in considering the true medical, ethical, and financial burdens related to non-medical switching. Further, it is unlikely that such risk–benefit balances are identical across different biologics, as accumulating data suggest that specific agents are preferable in UC versus CD and vice versa.
In conclusion, the review by [the authors] summarizes the current state of the evidence with regards to non-medical switching for bio-originator infliximab and CT-P13. While the totality of evidence appears reassuring, significant questions remain regarding the quality of and comparability of these data. Further prospective research is required before non-medical switching can be widely adopted, and long-term observation is requisite when it does occur to ensure the safety and effectiveness of such strategies.
Read the study here and the accompanying editorial here.
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ASBM Presents on Need for International Harmonization of Biologic Nomenclature at WHO 70th INN Consultation
On April 21st, ASBM presented to the World Health Organization’s (WHO’s) 70th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fourteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.
Due to coronavirus-related travel restrictions in place at the time of the consultation, the presentation was made online for the first time.
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 69th INN Consultation – held on October 22, 2019 and in which ASBM also participated – may be viewed here. From the Executive Summary:
ASBM was of the opinion that the delay in implementing the biologic qualifier (BQ) was a result of opposition to it and reasoned that arguments for delay were baseless and nullified. It also contended that during this delay period, WHO was pressuring smaller regulators and proponents to drop support for the BQ despite the ASBM having addressed the main objections raised by opponents.
A great majority of US physicians already support the FDA 4-letter suffix with most of them also supporting the decision not to apply the suffix retrospectively. The ASBM also reported that at the DIA annual meeting in June 2019, an FDA representative identified enhancement of pharmacovigilance and safe use as major factors in implementing their suffix, alongside the inconsistent use of other identifiers such as the National Drug Code (NDC) number. According to the FDA, there should be adequate mechanisms in place to differentiate adverse events arising from reference or biosimilar products.
In a Canadian survey of 2017, only 20% of physicians recorded the non-proprietary name in patient records and only 1% of those identified the medicine using the Drug Identification Number. The ASBM also queried whether the INN Expert Group’s recommendation to WHO had changed, highlighting that neither the WHO Constitution nor Bylaws require unanimous consent of all stakeholders. It felt strongly that if WHO had moved to introduce the BQ many member states would have adopted it by now. Even in the EU, adverse event reporting data shows that a need remains for a specific non-proprietary biologics identifier, such as the BQ, despite reporting by brand name being required by law.
ASBM felt that broad support for the BQ remains amongst regulators and prescribers and urged the WHO to act now and adopt the BQ.
Read more about ASBM’s work on the issue of biologic naming here.
Read the full Executive Summary of the 69th INN Consultation here.
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| ASBM Submits Comments on FDA Draft Guidance for Communications Regarding Biosimilars
On April 6th, ASBM submitted comments on the FDA’s recently published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials.
It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may encounter.
The Draft Guidance is among the deliverables in the FDA’s Biosimilars Action Plan (BAP) that outlines four key strategies to accelerate biosimilar competition, including supporting market competition and providing clearer direction to industry on the development of promotional materials for medical products.
ASBM’s comments reflected observations from ASBM Chair Madelaine Feldman, MD; Advisory Board Chair Philip Schneider MS, FASHP, FFIP; and Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association. From the comments:
One thing we’ve seen across Europe is that as more and more biosimilars are launched in a given product class, competition drives prices downward, discounts increase substantially, and biosimilar market share goes up. So we know what to expect, and what things to look for.
Thankfully we are seeing this happening in the US. Here we have a biosimilar filgrastim that launched with a relatively low 15% discount over its reference product. Today, with increased competition, that product has attained a majority share of the US market in its class with 55%. Late last year we saw the first rituximab biosimilar launch at a 10% discount over the reference product, and only a few months later the second launched at a larger, 24% discount.
We have every reason to believe this pattern will continue as we see it becoming routine for 3, 4, or 5 biosimilars approved for a reference product, and as these come on the market, manufacturers will continue to compete on price- moving from low discounts, to higher discounts.
ASBM representatives participated in a joint FDA/FTC Public Workshop held on March 9th at the FDA’s headquarters to discuss the guidance; as well as a related half-day event sponsored by the Hatch Center, Pfizer, and the Biosimilars Forum the following day, entitiled “Biosimilars: Breaking through the Barriers’.
Read ASBM’s comments in full here.
View all submitted comments here.
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| UPCOMING EVENTS
EULAR E-Congress 2020
Congress.Eular.org – June 3, 2020
BIO Digital Patient Advocacy Pavilion
https://www.bio.org/events/bio-digital – June 8-12, 2020
DIA Global Annual Meeting (Virtual)
DiaGlobal.org – June 14-18, 2020
DIA European Meeting 2020
Brussels, Belgium – June 30-July 3, 2020
World Drug Safety Congress 2020
Boston, MA – September 1-2, 2020
World Biosimilar Congress Europe 2020
Basel, Switzerland – November 3-5, 2020
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