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.
| OSU College of Pharmacy Launches ASBM-Developed CE Course on Biologics and Biosimilars
The Ohio State University College of Pharmacy is now offering a 1-hour Continuing Education (CE) course entitled Biologics and Biosimilars: and Introduction. The course is presented by OSU professor and ASBM Advisory Board Chair Philip Schneider, FASHP, FFIP.
The course is a primer on biologics and biosimilars, examining how these medicines are developed and approved as well as delving into policy considerations which affect pharmacy practice. The include the role of analytics and clinical trials in approval, biosimilar substitution practices, and the concept of interchangeability. The course is ACPE accredited and available to pharmacists nationwide.
The course is the first in a series on biosimilars presented by the College of Pharmacy’s Office of Continuing Professional Development. Future course entries will examine topics including non-medical switching, biologic pharmacovigilance and nomenclature, physician and patient perspectives on biosimilars, and the biosimilars market.
View the first OSU CE Course here (registration required).
Visit the OSU College of Pharmacy’s Office of Continuing Professional Development here.
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| ASBM Chairman Moderates Webinar at DDNC Policy Conference
On November 15th, ASBM Chairman Ralph McKibbin, MD moderated a panel discussion at the Digestive Disease National Coalition’s Fall policy-setting forum.
The Fall Forum ran from November 15th-19th and gathered together policymakers, caregivers, and patients to discuss the latest developments in digestive disease policy. The webinar included an overview of DDNC funding priorities, presentations from DDNC member organizations, and an informational session on the Safe Step Act.
The Safe Step Act is a bill which would regulate the utilization-management technique known as “step therapy”- where patients are required by insurers or pharmacy benefit managers to deny patients access to the medicines selected by their physicians, until they have failed one or more lower-cost treatments. Alaska Senator Lisa Murkowski, lead sponsor of the bill, presented.
A major topic of discussion at the five-day conference was a recent paper on step therapy entitled “Variation In Use And Content Of Prescription Drug Step Therapy Protocols, Within And Across Health Plans”. From the paper’s abstract:
Insurers limit the use of certain prescription drugs by requiring step therapy—that is, by allowing access only after alternatives have been tried and have failed. Using data from seventeen of the largest US commercial health plans, we examined step therapy protocols that determined patients’ eligibility for specialty drugs and identified ten diseases that are often subject to that requirement.
The authors’ analysis found that that 55.6 percent of step therapy protocols were more stringent than the corresponding clinical guidelines, and that these protocols varied widely both within and between. The authors observed that:
“These findings raise questions about potentially overly restrictive step therapy protocols, as well as concerns that variability across health plans makes protocols onerous for patients and practitioners alike. The findings thus suggest the need for state and federal legislation.”
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| ASBM Presents at World Biosimilar Congress Europe
From November 9th-11th, ASBM participated in the World Biosimilar Congress 2021 Europe, 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 (GCCA).
The theme of the three-day meeting was “Celebrating 15 years of Biosimilars in Europe.” Professor Schneider chaired the Keynote Panel Discussion titled “Regulatory lessons learned from the past 15 years and what can regulatory guidelines do to improve access going forward.”
Members of the panel included a representatives from the European Medicines (EMA) and drug manufacturers. There was a robust conversation surrounding the issue of interchangeability of biosimilars and the role clinical trials should play in market authorization. It was also agreed that physician and patient involvement in developing regulatory guidelines is important and strong pharmacovigilance programs are essential.
There were several sessions on the topic of sustainability that addressed the need for balance in the efforts to contain costs while maintaining a competitive marketplace by increasing the number of biosimilars and creating new reference products. Schneider chaired the sessions on this topic, gave a presentation titled “Problems with Pharmacovigilance Programs: an Opportunity for Improvement,” and chaired a panel discussion “Creating a sustainable future for biosimilars.” Topics discussed in the panel included the need to included factors other than price such as drug administration devices and supply chain reliability in tender decisions and the pros and cons of gain-sharing programs that are intended to create the incentive to use biosimilars in the clinical setting.
Andrew Spiegel chaired a 3-hour session and hosted a Roundtable on Biosimilars in Oncology, at which the topic of forced biosimilar switching was discussed. The oncologists present expressed their strong opposition to the practice.
Spiegel also hosted two Fireside Chats during the meeting. The first was with Antonella Cardone, executive director of the European Cancer Patient Coalition. Its theme was ‘The Importance of Biosimilars in Oncology” and featured patient survey data. “It was clear from the European patient community is largely in alignment with ASBM members on opposing forced switching and preferring to make treatment decisions with their physicians, said Mr. Spiegel. The second Fireside Chat was with a representative from a biosimilar manufacturer, Sundar Ramanan, entitled ‘Promoting Equitable Access of Biosimilars Across Therapeutic Areas.”
Read more about the World Biosimilar Congress 2021 Europe here.
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| FDA Official Gives Update on U.S. Biosimilar Program
On November 8th, Jacqueline Corrigan-Curay, principal deputy center director for FDA’s Center for Drug Evaluation and Research (CDER), gave an update on CDER’s biosimilar development program. The remarks were made at the meeting of the Association for Accessible Medicines’ (AAM) GRx+Biosim conference, held virtually.
Dr. Corrigan-Curay called the biosimilar product development program a “great success” in terms of approvals, uptake in certain sectors, and engagement. She said that as of November, FDA has approved 31 biosimilars for 11 reference products. This figure is up from the 29 biosimilars approved in May 2021.
These approvals include two interchangeable products. The first interchangeable biosimilar was Mylan’s Semglee (insulin glargine-yfgn) followed by Boehringer Ingelheim’s Cyltezo (adalimumab-adbm). Interchangeable biosimilar products may be substituted at the pharmacy level for their reference products without prescriber intervention, much as generic drugs may be substituted at the pharmacy level for reference-listed drugs.
FDA is also seeing an “increasing uptake of this program in oncology,” added Corrigan-Curay. She added that while there is more uptake of the program in the oncology space, adoption is less prevalent in other treatment areas.
Read more about the update here.
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| ASBM’s Madelaine Feldman Testifies at House Oversight Committee
On November 17th, ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR testified at a public hearing of the Congressional Oversight Committee. Entitled “Reviewing the Role of Pharmacy Benefit Managers in Pharmaceutical Markets”, the hearing examined the role of PBMs in contributing to higher drug prices. From Dr. Feldman’s testimony:
The out-of-pocket costs for these miraculous RA medications – as well as medications for many other serious, chronic illnesses – have risen to levels where many patients simply can no longer afford them, and that is true even for biosimilars. Clearly, something is not working the way Congress intended. That something begins with the formulary…
High drug prices are not a mere byproduct of this system; they are at the heart of its design, since a drug’s list price must be high so as to offer “headroom” for these discounts, rebates, and fees to the PBM. This creates a broken market in which competition actually raises prices. In this way, our drug pricing system is more akin to selling a house [winner = highest bidder] than building a house [winner = lowest bidder].
Read more about the Oversight Committee hearing here.
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| Gewanter Named President-Elect of Medical Society of Virginia
Past ASBM Chairman Harry Gewanter, MD, MACR was recently named to the Board of Directors of the Medical Society of Virginia as President-elect. The nomination was made at the society’s 2021 House of Delegates meeting. Dr. Gewanter will assume the MSV presidency for a one-year term beginning at the MSV’s next annual meeting in October 2022.
Dr. Gewanter served as ASBM’s Chairman from 2014-2017 and continues to serve as a member of ASBM’s International Advisory Board. While ASBM chair, he provided valuable testimony to many state legislatures as they implemented biosimilar substitution legislation.
He is a graduate of Duke University and received his medical training at Wayne State University. He conducted his pediatric internship and residency at the University of Rochester/Strong Memorial Hospital. He has practiced in Richmond, Virginia since 1983. After more than three decades, Dr. Gewanter decided to retire from clinical practice to focus his efforts advocating for systemic change for people with disabilities. He is especially passionate on issues affecting children and youth with special health care needs.
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| UPCOMING ASBM EVENTS
16th Biosimilars Congregation 2021 Virtual – December 9, 2021
World Biosimilar Congress USA 2022 San Diego, California – March 9-11, 2022
74th INN Consultation Geneva, Switzerland – April 5-8, 2022
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