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.
More than 15 state legislatures have introduced legislation on substitution over the past few months and ASBM and our members have been very active sending letters of support, testifying at hearings and briefing state legislators on the issue of interchangeability and the need for physician notification. Virginia and North Dakota have both signed bills focused on patient safety into law. Currently Arkansas, California, Colorado, Florida, Illinois, Indiana, Maryland, Massachusetts, Oregon, Pennsylvania, Texas, Utah and Washington are considering legislation.
View our “In the States” page of the ASBM website to see letters of support and read the various bills.
ASBM Quoted in BNA Article on Substitution
ASBM Executive Director Michael Reilly talked to BNA reporter Bronwyn Mixter about biosimilar substitution state legislation.
“Michael Reilly, executive director of the Alliance for Safe Biologic Medicines (ASBM), told BNA that the states are moving forward with biosimilars legislation as a way to address both interchangeable and noninterchangeable biosimilars. Reilly said if a state does not have legislation in place, noninterchangeable biosimilars could be substituted for brand products.
“‘If you look to Europe as a model,’ they do not have automatic substitution or interchangeability and they encourage physicians to begin patients on biosimilars rather than on a brand biologic so that patients are not at risk from switching from the brand to the biosimilar, Reilly said.
“Interchangeable biosimilars do not exist and FDA has not yet established a pathway, Reilly said. ‘Nobody knows what an interchangeable is,’ he said. ‘This is about when the first biosimilar is approved and how it is treated. There has been a lot of rhetoric around what an interchangeable is, but there is no experience with interchangeability anywhere in the world,’ Reilly said.”
Read the article here.
HealthHIV Urges CO Legislators to Prioritize Patient Safety
On March 8, HealthHIV released a statement of support for Colorado Bill 1121 where Joseph Jefferson noted the three key reasons why:
“First, because of their unique nature and interaction with the immune system, it is essential that biosimilars be certified by the Food and Drug Administration as interchangeable with the original biologic.
“Second, prescribers must be notified of the substitution within a reasonable period of time. This is essential for patients managing HIV/AIDS who are often dealing with multiple medications and related chronic conditions. It is critical that the physician know exactly what treatment is administered to patients living with a compromised immune system.
“Finally, patients should be notified that the substitution has taken place, and HB 1121 allows for this. Patients living with HIV take a very active role in the management of their own health, and we believe it is their right to know exactly what treatment they have been given in order to monitor their body’s response, and then work closely with their physician and pharmacist, should they experience an adverse health event.”
Read the full statement here.
Dr. Gewanter Included in Inside Health Policy Article
ASBM Advisory Board Member, Dr. Harry Gewanter, was quoted in the Inside Health Policy Article “North Dakota Projects Lost Savings With Biosimilar Bill; Cost Debate Heats Up,” saying Dr. Gewanter:
“Rebutted arguments from the sponsor of the Virginia bill, which has since been signed into law, that it would lower drug costs, saying it was ‘pure speculation.’ He further said cost concerns are less important than safety monitoring of these riskier drugs.
“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 Sen. (Steve) Newman (R) touts.”
Read more here.
Global Healthy Living Testifies at North Dakota Hearing
On March 11, GHLF’s Allen Todd provided testimony at the North Dakota House Human Services Committee where he stressed the need for treatments to be decided by patients and their physicians, and that pharmacists should notify the prescribing physician after a substitution has been made.
Read his testimony here.
Letter to WHO
In advance of the World Health Organization’s (WHO) 56th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances that will be held in April, ASBM sent a letter advocating that all biologics should receive distinct non-proprietary names.
Read the letter here.
Biosimilar Summit in D.C.
On March 5, Dr. Dolinar presented at the Center for Business Intelligence 8th Annual Biosimilars Summit in Washington, D.C.
Dr. Dolinar’s presentation, “Assessing Global Standards for Biologic Medicines,” stressed the need for a global regulatory environment for biosimilars that places patient safety above all else and delivers high quality standards regardless of where the biosimilar is manufactured.
View his presentation here.
ASBM Statement on Sequestration
Before the sequestration went into effect, ASBM released a statement expressing concerns that cuts could delay the biosimilars pathway.
In the statement, Dr. Dolinar said:
“Our members are very concerned about the effects sequestration could have on the FDA’s ability to issue final guidance and, ultimately, to begin reviewing the safety and efficacy of biosimilars for approved patient use. The FDA must have access to the scientific and regulatory expertise needed to evaluate these complex products. The European Union and Canada, among other countries, have developed an approval pathway and have made biosimilars available to patients and we do not want budget cuts resulting from sequestration to slow down the process here in the U.S. Arbitrary cuts to the FDA budget will have a serious impact on patients. We call on Congress and the Administration to work together and seek a solution that avoids the sequestration-related cuts and helps make the biosimilar pathway a reality.”
Read the full statement here.
Biosimilar Insulins Impact Meeting in Dallas
Dr. Dolinar recently visited Dallas to give a “Clinicians’ Perspective on Biosimilars” presentation at the Biosimilar Insulins Impact on Clinical Practice Publications Roundtable Meetings.
View his presentation here.