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 & GaBI Host Non-Medical Switching Webinar
On July 20th, 2022 ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a 2-hour webinar entitled “Non-Medical Switching of Biologicals and Biosimilars: Canada, Europe, and the US”. The two-hour event offered an overview of non-medical switching practices in different regions and focused on the importance of safeguarding the patient-physician relationship. Watch video of the webinar here. The Non-Medical Switching webinar was the second in a series of webinars hosted by ASBM and GaBI this year highlighting key biosimilar policy issues. The first entry, hosted June 29th, examined “Key Factors for Successful Biosimilar Uptake in Europe, Canada and the US” and may be watched here. During the webinar, academic clinicians, patient advocates, policymakers and regulatory experts from Canada and the US shared their experience and knowledge. Topics discussed included an overview of non-medical switching policies in different countries; physician and patient concerns with non-medical switching; interchangeability of biolosimilars in the US and Canada, the importance of a multi-stakeholder approach protecting the physician–patient relationship when making substitution decisions. Presentations included:
Following the presentations, the event concluded with a panel discussion and Q&A session moderated by Steven Stranne, MD, JD (USA). Panelists included:
The discussion will continue in the third webinar in the series, “Ophthalmic Biosimilars” in September 2022. More information will be available soon. View the July 20th Webinar on Non-Medical Switching here. View the June 29th Webinar on Key Factors for Successful Biosimilar Uptake here.
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| Study: Non-Medically-Switched Breast Cancer Patients Receive Inadequate Information About Switch
A survey of 143 breast cancer patients and 33 oncologists examined their experiences during non-medical switching to a biosimilar trastuzumab from the reference product. The survey, which appeared in Breast Cancer Research and Treatment, suggested there is inadequate information for patients who are non-medically switched to a biosimilar. This is “inconsistent with best practices of patient-centered communication,” the authors concluded, and is a challenge to both the uptake of trastuzumab biosimilars and the physician-patient relationship.
Among the study’s findings:
The study authors collected comments representative of the switched patients’ experience. “I thought [the biosimilar] was the same.” said one. “Literally any information would have been more than I was given,” said another.
Read the full study here.
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| FDA to Host Workshop on Streamlining Biosimilar Development
The U.S. Food and Drug Administration is hosting a one-day virtual public workshop entitled, “Increasing the Efficiency of Biosimilar Development Programs,” on Monday, September 19, 2022. The event will run from 9am-4pm ET.
This public workshop will discuss statistical, scientific, and clinical methods for streamlining comparative clinical studies associated with biosimilar product development programs. This workshop will support the sharing of innovative ideas on the statistical approaches and clinical study design elements for streamlining these comparative clinical studies, which are the most expensive and operationally complex aspects of product development programs. Examples of these ideas include reducing sample sizes or modifying certain aspects of study designs that could improve the efficiency of biosimilar development overall.
The workshop will be held virtually for participants and will include presentations and panel discussions from speakers and panelists from the FDA, as well as external subject matter experts in biostatistics. This workshop will be of particular interest to biosimilar developers, academic researchers, and other stakeholders.
This virtual workshop is open to the public; register here.
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| 2022 Amgen Biosimilar Trends Report Preview Highlights Successes in US Market
In July, Amgen released a preview of its 2022 Trends in Biosimilars Report. The preview shares highlights of the U.S. biosimilar market ahead of a full report due this fall. Among the report’s findings:
The full report is expected in Q3 of 2022.
Read the 2022 Trends in Biosimilars Report Preview here.
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| UPCOMING EVENTS
ASBM-GaBI Webinar #3: Ophthalmic Biosimilars Virtual – September 2022 (Date TBD)
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
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