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.
State Legislation Update
Several state legislatures have have adjourned for the year, but we continue to urge support for California Senate Bill 598, which passed off the Senate Floor (29-4) on Friday, May 24. The bill now heads to the State Assembly where it is expected to be double-referred to the Assembly Business, Professions and Consumer Protections Committee and the Assembly Health Committee.
The earliest SB 598 could be heard is Tuesday, June 11.
Dr. Bruce Rubin Op-Ed featured in the Florida Herald Tribune
An Op-Ed by Dr. Bruce Rubin recently ran in the Herald Tribune titled “Medicine safeguard missed.”
In the piece he says:
“In my care of patients, I see pharmacist notification to a physician if he or she has substituted a biologic product for its interchangeable biosimilar as absolutely critical to provide proper management and care of my patients. If a patient has an adverse reaction to a medicine, I would need to be able to identify the drug that the patient is receiving to effectively care for my patient.
“I see great value in the introduction of more affordable biosimilar medicines, which will increase access for millions of Americans to a life-improving opportunity. Biologics have helped the field of neurology to treat some of our toughest cases. However, I believe that the doctor must remain at the center of the prescribing process in order to protect the safety of patients.”
Patient Calls for Notification in the Baltimore Sun
The Baltimore Sun had an Op-Ed by a Rockville patient on the biosimilar substitution debate in Maryland and the critical need for notification.
In “Debate over ‘biosimilars,’ patient safety must come first” the author wrote:
“I’m grateful for biosimilars, as I welcome anything that can lower the costs of my medicine. But I believe a few common-sense safety measures need to be put in place to protect patient health when substitutions are made.
“First, pharmacists should only be allowed to substitute a biosimilar if it has been approved by the Food and Drug Administration as interchangeable with the original biologic medicine. This means it has undergone rigorous testing, and it has been shown to be close enough to the original product that the benefits outweigh the risks.
“Second, doctors must have the right to tell pharmacists that a prescribed biologic shouldn’t be substituted with a biosimilar, because the biologics might be necessary for a patient with allergies or multiple conditions like me. This is the same process that’s in place for generic drugs. It doesn’t make sense to be any less cautious with a drug that’s much more complex.
“Third, and most important to me, pharmacies should be required to notify patients and their doctors when a biosimilar substitution is made. This simple step, along with the FDA’s determination that the drug is interchangeable, would give me 100 percent confidence in what I’m about to put into my body. If my doctor and I don’t know I received a different drug, how can we both know to be mindful of any new reactions or changes?”
EuropaBio, Global Colon Cancer Alliance and ZERO Join ASBM
We are very excited to announce three new members are joining ASBM. On the international front, EuropaBio and the Global Colon Cancer Alliance are now members. ZERO – The Project to End Prostate Cancer, the largest prostate cancer patient group will also be joining. We look forward to the valuable experience they each bring in regards to biosimilar policy focused on patient safety.
New Advisory Board Members Join ASBM
In addition to adding new organizations to our membership, we have also had several new International Advisory Board Members join ASBM.
Dr. Frank Lavernia has been a practicing diabetologist in South Florida for over 30 years and is the founder and director of the North Broward Diabetes Center in Pompano Beach, Florida.
Dr. Marc J. Inglese is an Assistant Clinical Professor in the Division of Dermatology at the Florida State University College of Medicine and a partner at Dermatology Associates of Tallahassee.
Spencer Lieb is an HIV/AIDS Research Coordinator, Epidemiologist with the AIDS institute who is also an AIDS patient.
Stephen Murby is a board director of Consumers Health Forum of Australia, a member of the Stakeholder Advisory Committee of the Australian Independent Hospital Pricing Authority and a member of IAPO’s 6th Global Patents Congress Advisory Committee and a Life Fellow of the Royal Society of Arts.
Video Interviews with ASBM Executive Director Michael Reilly
Executive Director Michael Reilly spoke with Bloomberg BNA on the challenges facing the biosimilars process both in the U.S. and abroad. He also did a video interview with John Lewis and the Association of Clinical Research Organizations.
DIA Conference in Boston
On June 24, Dr. Dolinar will be participating on the Characterizing Drug Shortages and Their Causes: Anticipating Future Trends panel at the DIA 2013 49th Annual Meeting program at the Boston Convention and Exhibition Center.
Ottawa Forum on Naming
Dr. Dolinar will be participating in the Regulatory Forum on Biologic Product Naming and Traceability in Ottawa on June 26 to discuss the various regional approaches to biologic naming and the potential implications of the current INN (International Non-Proprietary Name) system.