Who We Are
The Alliance for Safe Biologic Medicines is an organization 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 the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.
Our Perspective
Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
| ASBM Presents at WHO 75th INN Consultation
On October 18th, ASBM participated in the World Health Organization’s 75th Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the nineteenth INN Consultation in which ASBM has participated. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.
The proceedings at the Consultation are bound by confidentiality pending the WHO’s publication of the Executive Summary. ASBM will share the Executive Summary when it is published in the coming months.
From the WHO’s Executive Summary of the 74th INN Consultation, at which ASBM presented in April 2022:
ASBM noted that it was a decade ago that the WHO recognised the need to improve biological PV and that a WHO survey in 2020 found that the lack of an international standard remains an issue of concern that can lead to PV problems. Several early supporters of universal distinct naming have gone their own way due to lack of WHO action, but have expressed willingness to harmonize should the WHO act. ASBM will continue to work with regulators worldwide to move a global nomenclature policy forward…The Chair added that the Expert Group is looking at how to progress naming for these biologics and that the concept that was developed previously, viz., the biological qualifier (BQ), will be taken forward and discussed at WHO management level. Thus, the continued presence of ASBM at these sessions has not been in vain.
Read the WHO’s summary of the 74th INN Consultation here.
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| Amgen Releases Full 2022 Biosimilar Trends Report
In October, Amgen released its full 2022 Biosimilar Trends Report. The report’s findings had been previewed earlier this year by Amgen’s Global Biosimilars Commercial Lead, Chad Pettit at a June 29th webinar hosted by ASBM and GaBI Journal.
View the webinar “Key Factors for Successful Uptake of Biosimilar Markets” here. Read GaBI Journal’s Meeting Report here.
The full report further documents the tremendous success of the U.S. biosmilars program in promoting competition, increasing biosimilar uptake, and generating savings for the U.S. health system. From the report:
To date in the US, 39 biosimilars have received regulatory approval, and 22 products have been launched. These launches have helped create an estimated $21 billion in savings for the healthcare system over the past 6 years.
Medicare Part B reimburses providers for biosimilars at the biosimilar’s Average Sales Price (ASP) plus a 6% addon of the reference biologic’s ASP. In other words, Congress kept the field level by providing physicians the same add-on amount regardless of whether they prescribe a reference product or a biosimilar. This helps all manufacturers compete on equal terms.
The report also emphasized that continued stakeholder education was critical to the market’s continued success:
As biosimilars expand into new therapeutic areas and enter the pharmacy benefit, education will continue to be critical to instill patient, provider, and pharmacist confidence in the role of biosimilars as viable and integral treatment options.
Read the Amgen 2022 Biosimilar Trends Report here.
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| ASBM Physician Survey Featured in Oncology Journal
ASBM’s recent survey of 401 U.S. physicians was featured in the October issue of the journal Oncology Practice Management. The article discussed a poster presentation given by ASBM Chairman Ralph McKibbin, MD, FACP, FACG, AGAF at the Drug Information Association Global Annual Meeting (DIA 2022) on June 20th, in Chicago, IL. View the poster here. The survey findings consistently reflected the high importance to respondents of preserving patient and physician choice regarding treatment decisions. From the article:
Despite expressing a high level of confidence when it comes to switching to or prescribing a biosimilar, 58% of survey respondents said they were uncomfortable with third-party substitution for nonmedical reasons related to cost or coverage. In addition, 69% of respondents said it was “very important or critical” that patients and physicians collaborate on the decision to choose the most suitable biosimilar and 67% said that it was “very important or critical” that they were able to prevent a substitution they considered inappropriate. Results of the survey also showed that the majority (71%) of physicians felt that payers should reimburse several biologics in a specific class, including the reference drug with its biosimilars, and 74% felt that private and public payers should base their decisions regarding biosimilars coverage on factors other than cost. When asked about preferred biosimilar access, 81% said that their patients could be best served under the type of scenario used throughout most of Western Europe, in which biosimilars and reference products are both reimbursed and biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not allowed. Only 8% supported an access scenario used in several Canadian provinces, in which only a preferred, government-selected product is reimbursed and to which both new and stable patients must be switched. Eleven percent said that they are unsure. Read the Oncology Practice Management article here. View Dr. McKibbin’s poster presentation here. View or download the poster here.
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| ASBM’s Schneider Discusses Pharmacist, PBM Role at National Policy & Advocacy Summit on Biologics
On October 19th, ASBM Advisory Board Chair Philip Schneider participated in the 7th Annual National Policy & Advocacy Summit on Biologics, The event was hosted in Washington, DC by the Biologics Prescribers Collaborative and was also streamed online.
Professor Schneider appeared on the opening panel discussion entitled “The Emerging Biologics Landscape”, which also featured Chad Pettit, Executive Director of Marketing at Amgen, and Wesley Mizutani, MD, a rheumatologist with Optum Medical Group. The discussion was moderated by David Charles, MD, founder of the Alliance for Patient Access.
Schneider discussed the pharmacist role regarding biosimilars, which includes keeping effectiveness & safety at the forefront of treatment decisions as our health system work to make responsible use of limited resources.
Another major topic of discussion was the role of pharmacy benefit managers (PBMs) in treatment decision-making and their impact on patient access to care. PBMs have eveloved from entities which simply processed claims, Schneider explained, into powerful entities with the ability to move market share through formulary design and rebates. This disrupts the autonomy of prescribers when a third party is effectively making clinical decisions. Pharmacists also feel they are losing control, as economics is often emphasized over medication effectiveness and patient health. Putting money into an intermediary often drives cost upward, Schneider observed. View the panel discussion, “The Emerging Biologics Landscape”, followed by the rest of the event here.
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| ASBM, IFA Observe World Sight Day 2022
World Sight Day is observed worldwide every year on the second Thursday of October. This World Health Organization-designated day fell on October 13th this year. The purpose of World Sight Day is to increase public awareness about blindness, vision impairment, vision care, and ocular issues. The WHO estimates that 1 billion people worldwide suffer from near or distant vision impairment due to delayed diagnosis and treatment. Although it can affect individuals of any age group, those over 50 years of age are more likely to experience it. Blindness or vision impairment can limit a person’s everyday life, prospects for employment and other aspects of their personal lives, including their ability to travel.
ASBM is quoted in a press release about World Sight Day from our partner the International Federation on Ageing (IFA) which is leading an educational campaign regarding the arrival of ophthalmic biosimilars in Canada:
In advance of World Sight Day on October 13th, the International Federation on Ageing (IFA) in partnership with national and global organizations wants to drive action for eye care, to improve the situation for those impacted by vision loss and blindness, now, and in the future. While global agencies support initiatives to improve, restore, and maintain vision for people around the world, many Canadians need to prepare for policy changes about their eye treatment that have the potential to impact patient and physician autonomy.
From the press release and informational packet:
“The Alliance for Safe Biologic Medicines (ASBM) supports the introduction of biosimilars as an important tool for offering patients new therapeutic options and reducing healthcare costs. The tremendous success of biosimilars in European markets has shown that countries need not sacrifice physician and patient’s choice to enjoy substantial savings. This is accomplished through competition between many reimbursed products, rather than forced switches. Physicians and patients in Canada deserve no less – yet they are increasingly seeing their choice restricted rather than expanded. With the arrival of ophthalmic biosimilars, we must heed the concerns of these physicians and their patients regarding unnecessary switching, so that we do not risk long-term harm to patients for short-term savings” states Michael Reilly, Executive Director, ASBM.
Read the IFA’s educational document- including a backgrounder on ophthalmic biosimilars, here.
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| FDA: “Incorrect” to Assume Interchangeables Are More Effective Than Biosimilars As reported in Generics Bulletin October 10th, Dr. Sarah McMullen, India country director for the US Food and Drug Administration underscored that there’s no real distinction in the standards to determine the safety or efficacy for both biosimilars and interchangeable biosimilars, and put forth a “fact check” to dispel the general notion among patients that interchangeables are perhaps better than other approved biosimilars.
Dr. McMullen’s remarks were made while addressing the BioPharma Conclave 2022, and echo those made by Leah Christl, Executive Director of Biosimilars Global Regulatory and R&D Policy at Amgen, in a July 20 webinar hosted by ASBM and GaBI Journal. Dr. Christl, former Director of Therapeutic Biosimilars and Biologics at the FDA’s Office of New Drugs, said in her presentation:
This designation of a biosimilar as interchangeable does not imply anything about the quality of the product. Non-interchangeable biosimilars are held to the same standards as interchangeable biosimilars…an interchangeable is not a quote-unquote “better” biosimilar, it’s just a biosimilar that’s undergone additional testing to generate additional data and information to support meeting the statutory definition and ultimately be eligible for pharmacy-level substitution.
The webinar, entitled “Non-medical switching of biologicals/biosimilars: Canada, Europe and the US” is the subject of a Meeting Report to be published in the next issue of GaBI Journal.
View a recording of the ASBM/GaBI Webinar featuring Dr. Christl’s presentation, here.
Read the full article about the FDA comments at Generics Bulletin here (registration required).
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| ASBM/Ohio State University Biosimilars CE Course Adds New Module on Patient Perspectives
In October, ASBM recorded the latest entry in its ongoing continuing education (CE) series in partnership with the Ohio State University College of Pharmacy. This course module, entitled “Patient Perspectives on Biosimilars”, represents part 6 of the 7-part series covering a wide range of biosimilar policy issues.
In this module, participants will hear different perspectives from the patient community regarding biosimilars and how they are made available to patients. ASBM Steering Committee Member Andrew Spiegel will share his perspective as the head of two international patient organizations (the Global Colon Cancer Association and World Patients Alliance) as well as sharing the perspectives of several other patient advocacy experts from the U.S., Europe, Canada, and Australia.
Upon completion, participants will be able to:
The final entry in the CE series, entitled “PBM and Payer Practices” and featuring Immediate Past ASBM Chair Madelaine Feldman, MD FACR; will be available in the coming weeks.
View all the available OSU College of Pharmacy CE courses here. (registration required). View the course outline here. View a promotional trailer for the CE series here.
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| ASBM’s Feldman Discusses Biosimilars in 2023 at STAT Forum
On October 12, ASBM Immediate Past Chair Madelaine Feldman, MD, FACR participated in a forum held by STAT, entitled “Biosimilars’ Meteoric Moment”. The forum focused on the long-awaited arrival of multiple adalimumab biosimilars in 2023 and asked experts from a variety of fields to speculate on what 2023 holds for the biosimilars market. Speakers included:
During the one-hour panel discussion, Dr. Feldman discusses several factors which she believes will influence the success of the U.S. adalimumab biosimilar market, including interchangeability, recent federal legislation, and PBM formulary construction.
View video of the STAT Forum “Biosimilars’ Meteoric Moment” here.
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| ASBM Presents at World Drug Safety Congress
On October 4-5, 2022 ASBM Advisory Board Chair Philip Schneider participated in the World Drug Safety Congress Americas 2022, held in Boston, MA. The annual pharmacovigilance (PV) conference bills itself as “the largest commercial gathering of PV professionals in the world.
During the two-day conference, Prof. Schneider chaired both the Global PV Track and Advanced Therapies Track.
In addition to chairing the Global PV track Professor Schneider also presented on the role of distinguishable biologic nomenclature in improving global pharmacovigilance. Distinct biologic nomenclature, he argued, promotes the more accurate tracking of biologic medicines, including biosimilars. In addition, a harmonized system such as that proposed by the WHO, would facilitate the sharing of that information internationally.
Learn more about the World Drug Safety Congress here.
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| American Academy of Ophthalmology Cautions Against Biosimilar Substitution
In October, the American Academy of Ophthalmology hosted its annual meeting in Chicago and attracted participants from around the world, including ophthalmologists, optometrists, opticians, and other eye health care professionals. The conference featured presentations focusing on the latest advances in comprehensive eye care, including medical, surgical, and optical care. One area of discussion at the meeting was the long-anticipated arrival of ophthalmic biosimilars. (The FDA approved the first ophthalmic biosimilar in September 2021.)
The AAO had released a statement earlier this year which raised concerns about differences in the inactive ingredients (excipients) between bevacizumab biosimilars and their reference products. Bevacizumab is often prescribed off-label for ophthalmic use. While a biosimilar product has no clinically meaningful differences in terms of safety, purity, and potency to the reference product for its labeled indications, The excipients – including the stabilizer or buffer — may differ from what is used in the reference product. While three bevacizumab biosimilars have been developed for use in the oncologic space, they have not been studied for ophthalmic indications and their inactive ingredients have not all been approved for use in the eye.
Among the statement’s recommendations:
Read the full AAO statement here.
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| UPCOMING EVENTS
ASBM-GaBI Webinar #3: Ophthalmic Biosimilars Virtual – December 2022 (Date TBD)
Biosimilars Training Program Watch Party Virtual (Register here) – December 7, 2022
Festival of Biologics 2022 USA San Diego, CA – March 20-22, 2023
WHO 76th INN Consultation Geneva, Switzerland – March 28, 2023
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