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.
State Activity
With the start of a new year, comes the start of a new legislative calendar. The past weeks have been very busy as many states are considering substitution legislation. ASBM and our members have been sending in letters of support in CO, VA, IN and ND and will continue to express our concerns for patient safety as more legislation is introduced.
All state activity can be found on our “In the States” page on our website. You can also find our One Pager on Automatic Substitution stressing that patients and physicians want doctors involved in treatment decisions.
Colorado
Colorado has been buzzing with the introduction of biosimilar substitution legislation House Bill 1121, which ASBM and our members have shown great support for. The CO bill was voted out of the House Health, Insurance & Environment Committee on February 12 and will be sent to the House and then the Senate for a full vote in the coming weeks. Thanks to Allen Todd with Global Healthy Living Foundation for testifying on behalf of patients before the committee.
Read his testimony here.
Prior to the hearing, Andrew Spiegel with the Colon Cancer Alliance sent in a letter of support saying:
“If patients and their physicians do not know what medicines they are taking, they can’t make the right decisions; they deserve to know when a biologic that has been working to keep them alive is being substituted, especially until we learn more about biosimilars.
“We agree that when interchangeable biosimilar products are substituted, communication among patients, pharmacists, and health care providers is essential to patient care. Opponents of the bill suggest that its provisions are onerous and intended to prevent the substitution of biosimilars from occurring, however, the physician notification requirement does not kick in until after the substitution has occurred. Physicians and pharmacists work together on a daily basis to ensure patients receive proper care, and there is no reason why dealing with highly complex, next generation medicines should be any different.”
Read ASBM, GHLF and CCA’s letters here.
Virginia
In Virginia, ASBM and several members sent letters of support for House Bill 1422. When the Senate version failed to adopt all of all patient protections that the House included in their bill ASBM, AfPA, CCA, GHLF, ICAN, Kidney Cancer and RetireSafe signed onto a joint letter with other patient groups urging the Senate to include provisions from the house bill.
The letter stated:
“For many of the more than two million Virginia patients—including our seniors, children and veterans—who suffer from one or more chronic illnesses, biologic medicines represent life-changing, and often lifesaving, therapies. They have improved quality of life, mitigated symptoms and reduced both disability and mortality rates.
“As important as these therapies are, it is just as important that public officials take special care to ensure the safety of the patients who rely upon them…That is why we strongly urge adoption by the Senate of all patient protections contained in House Bill 1422. This measure will bring Virginia state law in line with advances in modern medicine while also providing the essential safeguards that will ensure that Virginia patients receive exactly the medicines they need and will not be subject to potentially harmful substitutions.”
Read the full letter here.
Advisory Board Members Weigh In
Dr. Harry Gewanter, a pediatric rheumatologist in Richmond and member of the ASBM Advisory Board, penned an Op-Ed for the Richmond Times-Dispatch and also wrote a letter to the editor to the Lynchburg News & Advance in response to VA legislation.
In his Op-Ed “Legislation would protect patients taking complex meds,” he said:
“Specifically, the legislation would permit pharmacists to dispense a biosimilar that has been licensed by the FDA as substitutable with a prescribed biologic product, unless the patient’s doctor indicates otherwise or the patient asks for the brand-name version. It also would require the pharmacist to provide timely notification of this substitution to the doctor in a manner that is not a burden upon the pharmacist…Why is this important? We already know that each person responds differently to any medication, chemical or biologic. Generic chemical medications are easier to manufacture with less variability between them. However, since biologics and biosimilars are created using living cells, using current technology they can be closely approximated, but not necessarily exactly replicated. This creates a much greater chance of differences during the creation of a biologic and its biosimilar imitations. Any slight alteration in the production process could influence the effectiveness of a biologic and create unknown or negative consequences.”
Read the Op-Ed here.
In his letter “Healing or dollars?” Dr. Gewanter points out that the Senate version of the VA bill:
“Eliminates this critical communication between pharmacists, patients and their physicians in 2015. If I do not know that my patient with juvenile arthritis is not doing well because a substitution of a medication has occurred, I may change treatments or submit this child to many other evaluations that are not necessary. Chronic illness care requires close and ongoing communication between all members of a patient’s health care team. As a physician and a parent, I believe this communication and the resultant patient safety is far more important than any theoretical monetary savings [the Senate bill] touts.”
Read the full letter to the editor here.
Indiana and North Dakota
We have also been following the bills in both Indiana and North Dakota and have sent in letters of support, highlighting the importance of allowing substitution as long as the biosimilar has been determined by the FDA to be interchangeable with the prescribed product for the specified indicated use and that the physician is notified.
Read the letters here.
Upcoming Conference
Dr. Dolinar will be presenting at CBI’s 8th Biosimilars Summit, on the “Assess Global Quality Standards for Biologics in Regulated and Unregulated Markets” panel on March 5 in Washington, D.C.
Read more on the conference here.
