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 Statement on Prescription Drug Price Reduction Act (PDPRA)
On July 25th, the U.S. Senate Committee on Finance passed the Prescription Drug Pricing Reduction Act (PDPRA) of 2019, in a vote of 19-9. On July 29th, ASBM released a statement outlining concerns with one of the bill’s provisions. From the statement:
The stated aims of the bill include lowering prescription drug prices and boosting biosimilar uptake; these goals are shared by ASBM and many others in the physician and patient advocacy community. One provision in the PDPRA, however, raises serious concerns.
According to the bill, higher reimbursement rates will be paid to physicians who prescribe biosimilar biologic products under Medicare Part B than originator biologic products. If implemented, this plan to provide the doctor a 33% bonus for use of a biosimilar would insert financial incentives where patient interests should prevail. Every patient should be confident that their physician will prescribe the product that is in their best interest…not the one that is the most profitable to the physician personally. This proposed scheme fundamentally undermines the patient-physician relationship of trust.
ASBM’s position has been and continues to be that treatment decisions should be based on what is best for the patient, unfettered by third-party influence. That decision should take into consideration a number of factors, including the affordability of the drug for the patient, not profit for the physician.
Read the full statement here. |
| Two New Biosimilars Available in US in July
On July 19th, biologics manufacturers Amgen and Allergan announced that the biosimilars Mvasi® (bevacizumab-awwb) and Kanjinti® (trastuzumab-anns), which reference Roche cancer drugs Avastin® (bevacizumab) and Herceptin® (trastuzumab), respectively, are now available in the US.
“As the first products from our collaboration with Amgen to be launched in the country, Mvasi® and Kanjinti® reinforce our ongoing dedication to providing patients with additional treatment options,” said David Nicholson, chief R&D officer at Allergan.
The drugmakers stated that both biosimilars will have a 15% lower wholesale acquisition cost (WAC) than their reference treatments. The companies added that at launch, Mvasi® will be priced 12% below Avastin®’s current average selling price, with Kanjinti® carrying a 13% lower average selling price versus Herceptin®.
Mvasi® became the first cancer biosimilar in the US with its approval for multiple cancer types in 2017. Kanjinti® was authorized by the FDA in June for breast and gastric cancer, marking it the fifth approved biosimilar referencing Herceptin®.
Read more about the launches here.
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ASBM Poster Abstract Accepted at ESMO Congress 2019
On July 18th, ASBM was notified by the European Society of Medical Oncology (ESMO) that its poster abstract submission was accepted for the ESMO Congress 2019, to be held in Barcelona, Spain from September 27th to October 1st.
ASBM’s abstract is entitled “Biosimilar Substitution: European Prescriber Perspectives”, and will examine in detail the perspectives of European physicians on several biosimilar policy issues including prescription autonomy, non-medical switching, tendering practices, and product identification. A key focus will be on the perspectives of oncologists.
Data will be drawn from a 2019 ASBM survey of 575 European prescribers of biologic medicines from a variety of specialties, which will be released this fall.
Read more about ESMO Congress 2019 here.
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ASBM Joins Patient Advocacy Groups in Opposing Shared CMS Billing Codes for Multiple Biologic Products
On July 16th, A group of patient advocacy organizations sent a letter to Sen Finance Committee members Ron Wyden (D-OR) and Chuck Grassley (R-IA), opposing any changes to CMS policy that would result in the use of shared billing codes to cover multiple different products. The letter was organized by ASBM member Alliance for Patient Access (AfPA) and the Biologic Prescribers’ Collective (BPC), a project of AfPA.
ASBM and AfPA were among the many patient advocacy organizations that opposed the use of shared billing codes by CMS. Read ASBM’s September 2017 comment letter to CMS opposing the shared billing code policy here. In November 2017, CMS announced the reversal of the policy, following a public comment period which found strong opposition among patient advocacy organizations, physician societies, and manufacturers of both originator biologics and biosimilars. It has been estimated that the adoption of unique billing codes will save $65 billion to Medicare over ten years.
In an Inside Health Policy article published June 29th, Sen. Wyden had proposed returning to the policy of shared codes. |
ASBM Exhibits, Presents at DIA 2019 Global Annual Meeting
From June 24th to June 26th, ASBM exhibited at the DIA 2019 Global Annual Meeting in San Diego, CA. The meeting hosted thousands of professionals in the pharmaceutical, biotechnology, and medical device communities from more than 50 countries around the globe and 400+ exhibiting companies.
ASBM was represented at DIA 2019 by Executive Director Michael Reilly and Advisory Board Chair Philip Schneider, both of whom met with conference attendees to discuss ASBM’s work. Among the booth’s visitors was WHO INN Programme Lead Dr. Raffaella Balocco, who was a speaker at a panel on global pharmacovigilance.
Literature was distributed at ASBM’s booth on key biosimilar policy issues including: biosimilar basics, distinct naming, substitution and interchangeability, product labeling, indication extrapolation, and international harmonization of biologic nomenclature.
On Thursday, June 27th, Dr. Schneider participated in a session entitled “Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars“. In his presentation, Schneider discussed the importance of redundancy in high reliability systems, with respect to clear product identification and biologic naming. Schneider noted that in Europe, where multiple biosimilars share a nonproprietary name with the originator biologic upon which they are based, roughly a third of adverse event reports for infliximab products do not identify the specific product responsible by its brand name.
View Dr. Schneider’s presentation here.
Read more about the ASBM’s DIA exhibit and presentation here.
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ASBM’s Michael Reilly Published in Vancouver Sun
On June 24th, the Vancouver Sun published an op-ed by ASBM Executive Director Michael Reilly expressing concern about a recently-announced British Columbia mandated-switching policy. The policy, announced May 27th, will forcibly switch 23,000 patients to biosimilars in the coming months.
The op-ed points out that the proposed forced switch policy in BC misconstrues the European experience with biosimilars which has primarily left medical decisions in the hands of the treating physicians. From the op-ed:
Biosimilars have increased competition, expanded the choice of products physicians can choose from, increased the number of patients with access to these highly effective biologics, and provided headroom to fund innovative drugs.
However, it is important to note that in the vast majority of European countries, the decision of what medicine to choose has remained with the treating physician in consultation with their patient — contrary to the government mandated forced switch of well-treated patients announced by [BC Health Minister Adrian] Dix.
Furthermore, Health Canada, like the European Medicines Agency, recommends that a decision to switch a patient being treated with a reference biologic drug (innovator product) to a biosimilar should be made by the treating physician in consultation with the patient and taking into account available clinical evidence and any policies of the relevant jurisdiction.
Read the full op-ed here.
Read ASBM’s Fact Sheet covering the differences between BC and EU substitution policies here. |
| ASBM Exhibits at 2019 BIO International Conference
From June 4th-6th, ASBM exhibited at the 2019 BIO International Convention held in Philadelphia, PA. Each year, the Convention attracts approximately 16,000 attendees from more than 5,000 companies and from 70 different countries.
ASBM was represented at the booth by Andrew Spiegel, ASBM Steering Committee member and executive director of the Global Colon Cancer Association. Conference attendees met with Mr. Spiegel and discussed key biosimilar policy issues including biosimilar naming and non-medial switching policy.
While at the BIO Convention, Mr. Spiegel also participated in a panel discussion with other patient advocates and biologic manufacturers to discuss the importance to patients of building a sustainable biosimilar market.
Read more about the 2019 Bio Convention here.
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| FDA Approves Two New Biosimilars in June
During the month of June, the FDA approved two new biosimilars, bringing the total approved to 21.
The first product, ZIRABEV® (bevacizumab-bvzr) is biosimilar to AVASTIN® (bevacizumab). Like its reference product, it is a vascular endothelial growth factor inhibitor indicated for the treatment of metastatic colorectal cancer. It is the second bevacizumab biosimilar approved by the FDA.
The second product, KANJINTI® (trastuzumab-anns) is biosimilar to HERCEPTIN® (trastuzumab). Like its reference product, it is a HER2/neu receptor antagonist indicated for the treatment of HER2 overexpressing breast cancer and the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. It is the fifth trastuzumab biosimilar approved by the FDA.
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| UPCOMING EVENTS
ESMO Congress 2019
Barcelona, Spain – September 27-October 1
World Biosimilar Congress 2019 – Europe
Basel, Switzerland – October 15-16
WHO 69th INN Consultation
Geneva, Switzerland – October 22
DIA Annual Canadian Meeting
Gatineau, Quebec – November 5-6
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