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 Shows Support for VA Legislation on Interchangeability
The Virginia House of Delegates introduced legislation on interchangeable biosimilars and held a hearing on the bill, H.B.1422, on January 15. To show support of the bill, Dr. Dolinar, the Colon Cancer Alliance, Global Healthy Living Foundation and the Kidney Cancer Association sent letters to members of the House Committee on Health, Welfare and Institutions.
We expect to see legislation on substitution in many other states and will monitor and engage accordingly.
Read more here.
Inside Health Policy Article on VA Legislation
Inside Health Policy highlighted the ASBM letters to VA delegates in the article “VA Bill Raising Bar For Biosimilars Substitution Falls In Line With BIO’s Principles.” The article said:
“The alliance principles call for physician authority to prevent the substitution, a requirement that physicians be notified of the product’s manufacturer and a notification process that doesn’t impose a burden on the pharmacist. The group also noted to Virginia lawmakers that ASBM and the Virginia Biotechnology Association hosted a September 2011 biosimilar education forum in Richmond that included local patient advocates and physicians.”
Read the article here.
ASBM Hosts Biosimilars Forum at University of Rhode Island, College of Pharmacy
On December 13, ASBM hosted a Biosimilars Education Forum at the University of Rhode Island, College of Pharmacy in Kingston, RI, after ASBM members took a tour of a facility that manufactures biologic medicines. The forum brought together policymakers, patient advocates, physicians, pharmacists and other stakeholders who discussed the importance of patient safety as biosimilars are introduced in the United States.
Participants included:
Dr. Richard Dolinar, ASBM Chairman
Andrew Spiegel, CEO of the Colon Cancer Alliance
Ronald Jordan, Dean of the University of Rhode Island – College of Pharmacy
Bruce Babbitt, PAREXEL Consulting
Doug Kraus, patient advocate
Read more about the event here.
Members Participate in CO BioScience Forum
A week before the RI event on December 6, several ASBM members took a tour of a biologic manufacturing facility in Longmont, CO and then attended a biosimilars forum hosted by Colorado BioScience, BIO and ASBM.
Dr. Dolinar participated in a panel discussion with Andrew Spiegel, CEO of the Colon Cancer Alliance, Philip Schneider, Associate Dean of the College of Pharmacy Administration at the University of Arizona and Fritz Bittenbender, Vice President of Alliance Development and State Government Affairs at BIO.
Read more here.
Food and Drug Law Institute Publishes ASBM White Paper
The Food and Drug Law Institute (FDLI) Policy Forum published a white paper on biosimilar naming authored by ASBM.
In the paper, ASBM made four policy recommendations:
All biologics should receive distinct non-proprietary names.
United States Pharmacopeia (USP) should work with FDA to adapt the product monograph system to accommodate the unique attributes of structurally-related, but distinct, biologic medicines.
The non-proprietary name of a reference product and product/s biosimilar to it should have a common, shared root but have distinct and differentiating suffixes.
Products designated interchangeable should have a distinct name from the reference product for which they are considered interchangeable to facilitate accurate attribution of adverse events.
Read the paper here.
Biosimilar News featured an article on the paper, as did Generics and Biosimilars Initiative (GaBI).
FDA Law Blog Post on White Paper
FDA Law discussed the ASBM white paper in the blog post “ASBM Says Distinct USAN Names for Biosimilars are Needed.” The blog points to ASBM’s call for:
“The need for clear, defined naming considerations and a system to implement an effective tracking and tracing of all biologics – not just biosimilars – stems from the potential of these products to be unexpectedly altered by the manufacturing process, handling, etc., in a manner that could cause unintended harm to patients. Whether the products that FDA approves will have the same name or a different name than the originator biologic will determine how well products can be traced back to a patient who has an adverse reaction.”
Read the blog here.
Alliance for Patient Access Releases White Paper
AfPA National Physicians Biologics Working Group released a white paper entitled, “Biologics: Can Patients Get What the Doctor Orders?” that examines barriers to therapeutic access resulting from current healthcare benefits design. This is their second paper in a series designed as an educational resource to inform the public and policymakers about the benefits of biologics, what makes them unique and distinct from conventional pharmaceuticals, and why these distinctions matter.
Read the paper here.
