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 Releases New European Survey in Dublin
On November 22, ASBM Executive Director Michael Reilly presented preliminary findings of a new survey on European physicians’ views on biosimilar naming at the Drug Information Association (DIA) Biosimilars Workshop in Dublin, Ireland. The key findings showed that nonproprietary names matter to patient safety:
- 53% of physicians surveyed felt that an identical nonproprietary name implies identical structure – which will not be the case for biosimilar medicines
- 61% of surveyed physicians said that identical nonproprietary names imply that the medicines are approved for the same indications – which is not necessarily the case
- 24% of reporting physicians record only the nonproprietary name of the biological product in the patient record
Read more on the survey here.
FDA Week Features Story on European Survey
In the FDA Week story “ASBM Uses European Biosimilar Naming Survey To Push Unique Names” Alaina Busch quotes ASBM on the release of the survey:
“‘The consistency of physician perspective in the U.S. and Europe with regard to nonproprietary naming of biologics is striking,” said ASBM Executive Director Michael Reilly, who presented the findings during a Drug Information Association biosimilar workshop in Ireland. ‘Identical nonproprietary names are generally understood to mean that the products are both identical and approved for the same indications — incorrect and potentially unsafe assumptions for biologics.’
“ASBM, also points out that physicians in Europe have hands-on experience with biosimilars, as opposed to doctors in the United States, where biosimilars have not yet been approved.”‘
Brookings Panel on Biologics
ASBM Chairman Richard Dolinar, MD and Executive Director Michael Reilly participated in the Engelberg Center for Health Care Reform at the Brookings Institution “Developing Systems to Support Pharmacovigilance of Biologic Products” forum on November 15, in Washington, D.C.
Mark B. McClellan, the Director of Health Care Innovation and Value Initiative for Brookings, moderated the panel “Potential Strategies to Identify Biologics for Safety Surveillance.”
Read more here.
Dr. Dolinar Interviewed on WFAS NYC
On November 21, Dr. Dolinar was interviewed on WFAS 1230 talk radio by guest host Seth Ginsberg of the Global Healthy Living Foundation. Dr. Dolinar gave an overview of what biosimilars are and the impact they will have on patients and physicians once they are approved in the U.S. WFAS AM 1230 is broadcast across the greater New York City area and reaches over a million listeners!
Listen to the interview here.
FTC Biosimilars Workshop to be Rescheduled
The FTC canceled the Biosimilars and Interchangeables Workshop on December 10, in Washington, D.C. due to inclement weather. Dr. Dolinar and seven ASBM Members were prepared to attend. The workshop has been rescheduled for February 4, 2014.
The FTC will be accepting public comments through March 1, 2014.
Read more here.
AfPA Working Group on Biologics
The Alliance for Patient Access (AfPA) held their National Physicians Biologics Working Group Meeting on November 15-16 in Chicago, IL where Dr. Dolinar gave the keynote address to attending physicians. In his address, Dr. Dolinar discussed the current state of biosimilars and explained the disconnect between the science and potential policies and how they will impact patient safety.
View the presentation here.
Upcoming Conferences
- Dr. Dolinar will give the keynote address at the Biosimilars and Follow-On Biologics 2014 Americas conference, which will be in Philadelphia, February 10-12
- The CBI 9th Annual Biosimilars Summit will also be held in Philadelphia, March 19-20
