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 Forum Brings Together Leaders on Biosimilars Issues in 2014
On February 25th, the Alliance for Safe Biologic Medicines (ASBM) held a forum to educate patient advocates, physician groups and members of its International Advisory Board on the complex issues related to biosimilars.
The half-day forum entitled, “Ensuring Access to Safe Biosimilars: Policy Developments and Emerging Challenges” focused on the challenges facing world regulators including the U.S. Food and Drug Administration (FDA), the importance of distinguishable nonproprietary names for biosimilars and the value of and need for patient, physician and pharmacist education on issues related to biosimilars.
ASBM Chairman Richard Dolinar, MD kicked off the event with an introduction to biosimilars followed by Executive Director, Michael Reilly highlighting three years of activities ASBM has conducted. Panel discussions, moderated by Brian Rye of Bloomberg Government, included patient advocates Marcia Horn, President of the International Cancer Advocacy Network; Andrew Spiegel, Executive Director of Global Colon Cancer Association; and Joe Jefferson, Director of Advocacy and Alliance Development of HealthHIV. In addition, cancer researcher Dirk Reitsma, MD spoke on the “Regulatory Challenges for the FDA,” and Kirsten Vadheim, PhD discussed “Developing International Regulatory Standards.” The concluding panel covered the development of “A Collaborative Approach to Pharmacovigilance” and featured Dr. Dolinar and Associate Dean Phil Schneider of the University of Arizona’s School of Pharmacy.
To view the full agenda and presentations, click here.
ASBM Submits Comments to the FTC
The Alliance for Safe Biologic Medicines submitted comments to the Federal Trade Commission (FTC) in regards to the “Follow-On Biosimilars Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition” hearing held in February.
In a letter to FTC Chairwoman Edith Ramirez, ASBM advocates for unique naming of biosimilars as well as physician notification on the state level. These points were discussed at the recent workshop, however, without the voices of patient advocates or practicing physicians.
“When it comes to biosimilars and the contentious issues of proprietary naming and state substitution laws, competitiveness and patient safety need not be mutually exclusive. They are in fact, complimentary.
…we need to be extremely thoughtful about how we set policy relating to these promising medicines and strike a balance that promotes health and safety, rather than forcing a binary response that is driven by profits instead of patients.
If you’re for patient safety, you can’t be against distinguishable naming.”
ASBM also addressed arguments made at the FTC meeting that physician notification was anti-competitive because it somehow undermines the reputation of biosimilars and indicates that they are somehow of poor quality.
ASBM replies, what they don’t “seem to understand is that interchangeable biologics are different from their innovator progenitors – but bioequivalent enough to be therapeutically interchangeable (as per the FDA). That’s not a ‘scare tactic,’ that’s just a fact.”
To read full comments to the FTC click here.
Indiana Substitution Legislation Headed to Governor
In Indiana, Senate Bill 262, has successfully moved through both chambers of the legislature with a strong vote of 92-5 in the State House. The legislation will now move to Governor Pence where it is hoped to quickly be considered.
ASBM has written Governor Pence in strong support of the enactment of this legislation stating, “We believe that when interchangeable biosimilar products are substituted, communication among patients, pharmacists, and health care providers is essential to patient care and, therefore, we fully support SB 262 and are concerned that patient safety will be compromised if this legislation is not enacted.”
To view legislation click here.
To view ASBM letter to Governor Pence click here.
Chairman Dolinar, Continued Authority on Physicians’ Perspectives of Biosimilars
ASBM Chairman Richard Dolinar, MD will be retuning to Philadelphia for the 9th Annual Biosimilars Summit, hosted by CBI on March 20th.
This year’s Biosimilars Summit will address regulatory challenges involving biosimilars and also state legislation related to physician notification when biosimilars are substituted for prescribed biologics. Dolinar’s presentation entitled, “Keeping Physicians Informed about Biosimilar Utilization” will focus on the difference between biosimilars and generic drugs as well as educating physicians about interchangeability and pharmacovigilance.
For more details on the conference, click here.
ASBM Scheduled to Participate in WHO 58th INN Consultation
ASBM Chairman Richard Dolinar, MD is once again on the docket to present comments before the World Health Organization (WHO) at its 58th Consultation on International Nonproprietary Names for Pharmaceutical Substances meeting to be held April 8th-10th.
The WHO has been considering creating a system of unique names and has recently made progress toward compromise amongst the different positions on the naming of biosimilars. Recent reports state that the WHO may consider assigning ‘biologic qualifiers’ — a short string of random letters added to the name of a biosimilar which would allow physicians and pharmacists to distinguish it from its reference biologic.
ASBM will present findings of its recent survey on European physicians’ views on biosimilar naming, which will officially be released on March 18th in Brussels.
Reilly Set to Address U.S. and International Biosimilars Regulations at FDLI Conference
On April 23rd-24th, the Food and Drug Law Institute will host their 57th Annual Conference in Washington, DC.
ASBM Executive Director Michael Reilly will appear in a breakout session on compliance and liability issues related to biosimilars. The panel, entitled “Interchangeability & Pharmacy Substitution Laws and Regulations in the United States and European Union”, will be moderated by John Manthei of Latham & Watkins LLP and also feature Kimberly Greco of Amgen and Christopher Mikson, MD of Jones Day.
For more information on the FDLI conference, click here.
