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 Shares Physician Perspectives on Non-Medical Switching
In February, ASBM released our latest video, “Non-Medical Switching”, featuring ASBM Chairman Ralph McKibbin, MD.
In the video, Dr. McKibbin shares new data from ASBM’s recent survey of 401 U.S. prescribers of biologics, as well as his own observations on the controversial practice. Among the survey findings:
“This kind of competition preserves choice and lowers costs”, explains Dr. McKibbin.
Survey data also show that U.S. physicians are confident in and comfortable prescribing biosimilars: 89% would prescribe one to a new patient, and 80% are comfortable switching a patient to a biosimilar. Third-party switching for non-medical reasons, however, raises concerns among physicians, explains McKibbin:
What’s at stake is who controls treatment decisions: will it be the physician and patient making a customized treatment plan based on the patient’s history? Or will it be insurance companies and pharmacy benefit managers funneling all patients onto the most profitable one-size-fits-all treatment program?
|Save the Date: ASBM and GCCA Biosimilar Training Program
On May 10-11, ASBM will sponsor a Biosimilars Training Program presented by the Global Colon Cancer Association, in partnership with the World Patient Alliance. The event is open to patients from any disease state.
This two-day interactive program is designed to educate patients worldwide about biosimilars and equip them with the tools they need to be more effective advocates and help ensure their country’s biosimilar policies work for the patients they represent.
Several ASBM-affiliated representatives will be presenting at the event including:
Join these and other speakers to learn about the benefits, as well as the new challenges biosimilars bring for patients.
Topics covered will include an overview of biosimilars, non-medical switching, pharmacovigilance considerations, and physician and patient perspectives. Patient advocates from around the world will also share their biosimilar stories and advocacy strategies.
|Senate Confirms Robert Califf as FDA Commissioner
On February 15th, the U.S. Senate confirmed Robert Califf as FDA Commissioner. The FDA had been without a permanent chief for 13 months. The vote was 50 to 46; with four Democrats and Sen. Bernie Sanders (I-Vt.) voting against Califf and six Republicans supporting his confirmation.
Califf had previously served as FDA Commissioner during the final 11 months of the Obama Administration.
Dr. Janet Woodcock, a veteran drug regulator who has led the FDA since January 2021 as acting commissioner, informed staff she will stay on as principal deputy commissioner, the FDA’s No. 2 position.
Read about the confirmation here.
|VA Study: Patients Switched to Biosimilar Infliximab More Likely to Stop Treatment
On February 18th, a study was published in the journal Current Medical Research and Opinion, which examined US Veterans Healthcare Administration (VHA) patients who were switched from innovator infliximab to the VHA-preferred biosimilar. The study found that those who were switched from the reference product to the biosimilar were almost 3 times more likely to stop treatment and 5 times more likely to switch to another innovator biologic.
The study also found that 91% of the patients who stopped the biosimilar switched back to the originator product. “Reasons for discontinuation and switching are unknown,” investigators wrote in the study.
The study examined VHA data from January 2012 to December 2019 for adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque psoriasis (PsO), ankylosing spondylitis (AS), or Crohn’s disease and ulcerative colitis (i.e. inflammatory bowel disease [IBD]) who were treated with either innovator or biosimilar infliximab.
Read the full study here.
|Study: Delivery-Device Differences Impacted Patient Acceptance of Biosimilar Switch
The national health plan of Iceland recently required patients on Humira (adalimumab) to switch to an adalimumab biosimilar, Imraldi, prompting negative feedback from many patients affected. The delivery device differed between the two products, and the biosimilar
These differences contributed to about half of the patients surveyed having a negative experience with the switch, according to a study published recently in Frontiers of Medicine.
The study was led by by Kristin Karlsdottir, PhD, MEd, of Landspitali University Hospital, and Anna I. Gunnarsdottir, PharmD, of the School of Health Sciences, University of Iceland. The study involved gathering a list of all patients treated through Landspitali University Hospital who had switched from Humira to Imraldi under the protocol and contacting them for a phone interview about their experience with the change. Of the patients contacted, 84.5% agreed to participate. The average age was 50.8 years, 53.5% were female, and 96% self-administered the drug.
Key findings of the study included:
Read the full study here.
|UPCOMING ASBM EVENTS
74th INN Consultation
Geneva, Switzerland – April 5-8, 2022
ASBM/GCCA Biosimilars Training Program
Virtual – May 10-11, 2022
DIA Global Annual Meeting 2021
Chicago, Illinois – June 19-23, 2022