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.
|REGISTRATION OPEN: July 20th ASBM/GaBI Webinar on Non-Medical Switching
On July 20th, ASBM and the Generics and Biosimilar Initiative (GaBI) will co-host the second in a series of webinars about key biosimilar policy issues. The webinar is entitled “Non-Medical Switching of Biologicals/Biosimilars: Canada, Europe and the US: Overview of Non-Medical Switching Practices of Biologicals/Biosimilars in Different Regions and the Importance of Safeguarding the Physician–Patient Relationship”, and will run from 10:00 am – 12:00 pm (EDT) on July 20th.
Academic clinicians, patient advocates, policymakers and regulatory experts from Canada and the US will share their experience and knowledge on medical switching and principles and guidance on interchangeability of biologicals/biosimilars, highlighting the specific concerns on, and the importance of a multi-stakeholder approach protecting the physician–patient relationship in the practice of non-medical switching of biologicals/biosimilars. The event will also contain a panel discussion and Q&A.
Topics discussed will include:
The discussion will continue in the third webinar in the series, “Ophthalmic Biosimilars” in September 2022. More information will be available soon.
ASBM and GaBI Host Webinar on Biosimilar Success in Europe and US
On June 29th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled “Key Factors for Successful Uptake of Biosimilars: Europe and the US: measures taken for improving biosimilar uptake and the potential role of healthcare providers and patients”. The event featured a keynote presentation by former U.S. Deputy Secretary of Health and Human Services Eric David Hargan.
Other speakers at the two-hour event included:
The event concluded with a panel discussion and Q&A session between participants, hosted by federal health policy expert Steven Stranne, MD, JD.
ASBM will share video of the archived event when it becomes available.
|ASBM Presents at International Federation on Ageing Biosimilars Webinar
On June 28th, ASBM Executive Director Michael Reilly presented at a Webinar hosted by the International Federation on Ageing (IFA) entitled “Emerging Trends in Ophthalmic Biosimilars Policy in Canada”. The webinar was part of IFA’s Eye See You educational program about biosimilars in ophthalmology.
View the webinar agenda here.
While a newer and less mature biosimilar market than those of Europe, the U.S. is quickly catching up, Reilly emphasized- with its rapid pace of approvals and uptake rates frequently in the 50-80% range- figures comparable to those seen in many European countries.
Europe’s success, Reilly argued, is due in large part to its near-total absence of automatic substitution, and its preservation of physician choice. In nearly every Western European country, for example, physicians may choose between multiple different products, all of which are reimbursed. He contrasted this approach with that of British Columbia, Alberta, New Brunswick, and Quebec- which have attempted to boost uptake through policies which forcibly switch patients from their physician-chosen medicines to government-preferred products.
Presentations from the event will be made available in the coming weeks.
|ASBM Chair Presents Poster at DIA Global Annual Meeting 2022
On June 20th, ASBM Chairman Ralph McKibbin, MD, FACP, FACG, AGAF presented a poster at the DIA Global Annual Meeting 2022 in Chicago, IL. The poster was entitled “U.S. Physician Perspectives on Biosimilar Substitution and Reimbursement Practices” and featured results from ASBM’s 2021 survey of 401 U.S. physicians. Among its key findings:
ASBM-GaBI Webinar #2:
Virtual (Register here) – July 20, 2022
World Drug Safety Congress
Boston, MA – October 4-5, 2022
WHO 75th INN Consultation
Geneva, Switzerland – October 18, 2022
Festival of Biologics Europe 2022
Basel, Switzerland – November 2-4, 2022