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.
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 and GaBI Spring Webinar Series to Examine Inflation Reduction Act
In April and May, ASBM and the Generics and Biosimilars Initiative (GaBI) will host two new webinars examining the implications of the recently-passed Inflation Reduction Act (IRA). The webinars will focus on the unintended consequences that may result from the implementation of IRA provisions. For example, provisions intended to reduce the expenses of biologic medicines in the short term may result in fewer medicines being introduced in the long term, reducing rather than increasing patient access to innovative treatments.
Presenters will discuss cost containment efforts in different countries and examine the impact these policies have had on patient care and healthcare professionals.
The new webinars build on the success of ASBM and GaBI’s Summer 2022 webinars, the first of which looked at factors which contributed to successful biosimilar uptake in the U.S. and Europe and was the basis for a whitepaper in GaBI Journal’s Q4 2022 issue. The second examined the controversial policy of non-medical switching and its implications for patients, physicians, and the long-term sustainability of biosimilar markets; a whitepaper based on the meeting will be featured in the Q1 2023 issue of GaBI Journal.
More information on the IRA webinars will be available in the coming weeks.
|ASBM/IFA Survey: Canadian Ophthalmologists Overwhelmingly Oppose Forced Switching
On February 28th, ASBM and the Ontario-based International Foundation on Ageing (IFA) released the results of a new survey of Canadian ophthalmologists that documents these specialists’ views on biosimilars and substitution practices.
The survey’s release comes on the heels of Ontario’s recent announcement that it would begin force-switching patients with a variety of conditions from their physician-prescribed products to government-chosen biosimilars, beginning March 31st.
The survey of 41 Canadian ophthalmologists, all of whom prescribe biologics in their practice revealed:
ASBM’s executive director, Michael Reilly, emphasized the stark contrast between Ontario’s plan and the more physician- and patient- centered substitution practices of Europe:
Seventy-eight percent of survey respondents said their patients would be best served by a European-style scenario where multiple products including innovator and biosimilars are reimbursed, with biosimilars encouraged for new patients but no automatic substitution.
Only 15% preferred a system similar to that of Ontario where only government-chosen biosimilars are reimbursed, new patients must be prescribed these products, and current patients are forced to switch.
View the full ophthalmologist survey here.
|IQVIA Webinar Looks at U.S. Biosimilar Outlook 2023-2027
On February 28, IQVIA held a webinar entitled Biosimilars in the United States 2023-2027. The webinar featured findings from the recently-released report of the same name. Among the report’s key findings:
The presentation was followed by a panel discussion featuring Sameer Awsare, MD, Associate Executive Director, the Permanente Medical Group; Alex Brill, MA, CEO, Matrix Global Advisors, Luke Greenwalt, MBA VP and Lead, Market Access Center of Excellence, IQVIA; Chad Pettit, MBA, Executive Director, Marketing, Global Biosimilars Commercial Lead, Amgen; Marta Wosinska, Ph.D. Visiting Fellow, The Brookings Institution; Murray Aitken, Executive Director, IQVIA Institute for Human Data Science; and Michael Kleinrock, Research Director, IQVIA Institute for Human Data Science.
Read the full report here here.
View a recording of the webinar here.
|FDA, FTC Release Biosimilars Report and Educational Resource
On February 28th, the U.S. Food and Drug Administration and the Federal Trade Commission released two documents related to biosimilars and interchangeable biosimilars – an educational resource for consumers and patients and a summary report from the 2020 public workshop titled “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.”
Three ASBM representatives participated in the joint FDA/FTC: Immediate Past Chair Madelaine Feldman, MD; Advisory Board Chair Schneider, FASHP FFIP and Andrew Spiegel provided comments at the meeting.
One presenter identified the chief barriers to biosimilar uptake as physicians (who needed educational outreach to increase their familiarity and comfort with biosimilars) and payers (whose policies can sometimes impede utilization, and need to be addressed). ASBM Advisory Board Chair Philip Schneider addressed these concerns in his remarks at the workshop:
Our recent survey of 579 European biologic prescribers shows high knowledge and high confidence in biosimilars. Depending on country, between 82% and 93% of prescribers considered themselves familiar or very familiar with biosimilars. Between 80% and 99% would feel comfortable prescribing a biosimilar to a new treatment-naïve patient. Between 46-76% would be comfortable switching a stable patient.
if the premise behind today’s proceedings is valid – that biosimilar uptake is strongly tied to physician confidence, the high physician confidence in biosimilars across the board should correlate with a consistently high uptake across the board.
Yet if we look at the biosimilar market shares across the six countries we surveyed, there is a wide variation among biosimilars in different product classes. For example, market share for the Epoetin biosimilar ranged from 6-84%. There are similar ranges for other biosimilars.
Clearly there are other factors besides physician confidence, which is uniformly high across the countries. These factors likely include differences between each country’s payer policies, differences in the length of time a biosimilar has been on the market, the number of biosimilars in a given product class, the discount of each product relative to the originator product, and other factors.
|Cardinal Health Survey Examines Physician Confidence, Concerns with Biosimilars:
According to a study released in February by Cardinal Health, while most providers think that biosimilars will positively impact care, few feel that the economic benefits of biosimilars to date are enough to motivate switching.
As reported in Medscape Medical News, the new survey of over 350 dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, clinicians shared their opinions on the rapidly evolving landscape of biosimilars, detailing top concerns about prescribing these medications and how they presently use biosimilars in clinical practice.
Out of 103 surveyed rheumatologists, 62% said they were very comfortable prescribing biosimilars to patients, and 32% said they were somewhat comfortable. Providers said they would be most likely to prescribe a biosimilar to new patients (40%) or if biosimilars were mandated by a patient’s health plan (41%). Nearly one-third (31%) of rheumatologists said that a discount of 21%-30% from a reference product would be necessary to consider switching a patient to a biosimilar.
There are several reasons why a rheumatologist may be wary of switching patients to biosimilars, said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “Rheumatologists will always express concern about changing medications that work well for their patients. It is not ideal to ‘force switch’ to a different product, even if it is almost identical,” he told Medscape Medical News in an email. “Also, we must remember that a patient on a biologic has failed traditional medications, which speaks to the struggle a patient must endure to get their disease under control. Fail-first situations can cause a rheumatologist to be initially resistant or hesitant to any changes.”
Read a Healio article breaking out the rheumatologist responses in the Cardinal survey here.
Festival of Biologics 2022 USA
San Diego, CA – March 20-22, 2023
WHO 76th INN Consultation
Geneva, Switzerland – March 28, 2023
DIA Global Annual Meeting
Boston, MA – June 25-29, 2023