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 Adds Module on PBM Practices to OSU College of Pharmacy Biosimilars Course
In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. The latest module is entitled “PBMs and Payer Practices” and is presented by ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR.
In this module Dr. Feldman explains unique features of the U.S. drug distribution system, with an emphasis on payer and pharmaceutical benefit manager (PBM) practices regarding biologic medicines and biosimilars. The bifurcated U.S. system (provider-administered vs. self-administered/pharmacy side) is examined in detail and the differences in these two sub-markets are highlighted: in particular, the degree to which savings can be achieved, and the role played by middlemen and manufacturer rebates in driving up rather than lowering costs. Utilization management tools used by payers (including non-medical switching and step therapy) are described, as are proposed regulations and legislation to restrict such practices.
Upon completion, students will be able to:
View all available modules of the ASBM/OSU Biosimilars Course here.
|Free Access to ASBM/OSU Biosimilars Course for ASBM Members
The Ohio State College of Pharmacy has provided ASBM with access codes for our Members who wish to view the first four modules of the ASBM/OSU College of Pharmacy Biosimilars Course at no charge:
Biosimilars Module 1: Introduction to Biologics and Biosimilars
To request free access to the course, email Ray Patnaude at email@example.com.
Promotional codes will be made for the remaining modules in the coming weeks.
View all available modules in the ASBM/OSU Biosimilars Course here.
|GaBI Journal Publishes Paper on ASBM US Physician Survey
In December, the Generics and Biosimilar Initiative (GaBI) published a whitepaper entitled “US prescribers’ attitudes and perceptions about biosimilars”, based on the findings from ASBM’s survey of 401 U.S. physicians fielded in late 2021. The paper was authored by ASBM’s Chairman Ralph McKibbin, MD, FACP, FACG, AGAF; and Executive Director Michael S. Reilly, Esq. The survey examines physician attitudes toward a wide variety of biosimilar policy issues including approval standards, non-medical switching, interchangeability, and reimbursement practices. While U.S. physicians were highly confident in the safety and efficacy of biosimilars, the survey revealed that maintaining control over treatment choices- including the ability to prevent substitution by a third party- was extremely important to the respondents. From the abstract:
Most physicians are comfortable prescribing biosimilars and comfortable switching stable patients to biosimilar product. Over half of physicians are more likely to prescribe biosimilars with interchangeable status and they are comfortable with pharmacy level substitution of these products. However, the majority want to keep the authority to prevent pharmacy level substitution if they specify so. When it came to switching patients to a biosimilar for non-medical reasons, the majority were comfortable doing this but fewer than half were comfortable with third party switching. In addition, most physicians favored a scenario where multiple products, including innovator and biosimilars are reimbursed, and biosimilars may be encouraged for new patients with no automatic substitution permitted.
Read the full paper online here.
|Ontario Announces Forced-Substitution Policy
In December, the Ontario government announced that it would follow other Canadian provinces including British Columbia, Alberta, Quebec and require mandatory switching to biosimilars. a mandatory switching in 2020, but implementation was delayed due to the COVID-19 pandemic. A nine-month transition period will begin March 31st. From the government’s announcement:
While the Ontario announcement justifies the policy by citing 15 years of successful use of biosimilars in Europe, it is important to note that in nearly every European country physicians retain free choice between multiple reimbursed products and forced substitution is rare. A 2017 survey of 403 Canadian physicians revealed that Canadian physicians are generally opposed to forced substitution:
Read the announcement from the Ontario government here.
|FDA Approves Eighth Adalimumab Biosimilar
On December 13th, the US Food and Drug Administration (FDA) approved its eighth biosimilar for Humira (adalimumab): Idacio (adalimumab-aacf).
Idacio is a tumor necrosis factor (TNF) blocker that blocks the production of TNF-alpha to reduce inflammation in the joints and skin. Idacio is indicated to treat a range of autoimmune disorders such as ankylosing spondylitis, Crohn’s disease, juvenile idiopathic arthritis, hidradenitis suppurativa, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis and uveitis. It is expected to launch in the US in July 2023 as self-administered prefilled syringes and self-administered prefilled pens (autoinjectors).
The approval brings the total number of biosimilars approved in the U.S. to forty.
Read more about the approval here.
The 2023 Treatment Choice Summit
Washington, DC – January 31, 2023
Festival of Biologics 2022 USA
San Diego, CA – March 20-22, 2023
WHO 76th INN Consultation
Geneva, Switzerland – March 28, 2023