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.
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State Update
As states are beginning their legislative sessions for the year, there are many biosimilar bills that have been introduced. ASBM supports legislation that encourages open communication between physicians and pharmacists where physicians know exactly which product is dispensed to patients. We applaud the many states that are including this important provision and will work together with those states that have not, to help ensure positive patient outcomes. A few states where legislation is pending, include: Colorado On February 5, the Senate passed SB 71, a bill ASBM supports that includes a prescriber communication provision. Georgia Idaho On January 26, the Idaho Senate Health Committee held a hearing on the proposed Board of Pharmacy rule on biosimilars that does not include prescriber communication. We are encouraging legislators to reject the rule and work towards a better solution that prioritizes patient safety. New Jersey Legislation in New Jersey is being considered and letters supporting bill A2477, S1705 are needed. Read ASBM’s letter here. We are monitoring legislation in many other states and will provide updates as we have them. |
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Hamburg Steps Down Dr. Margaret Hamburg, U.S. Food and Drug Administration (FDA) commissioner over the past six years, announced on February 5 that she was stepping down. Read more here. |
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ASBM Quoted in Inside Health Policy On January 6, the FDA released the 2015 Guidance Agenda that will be issued by the Center for Drug Evaluation and Research (CDER) as they prepare for the first biosimilar approval that could be as early as March. The guidance agenda slates four biosimilar documents the agency plans to put out this year including one on labeling, but there is no mention of a guidance specifically on the naming issue. Inside Health Policy interviewed ASBM Executive Director Michael Reilly for the article “FDA Guidance Agenda Doesn’t List Biosimilar Naming, But Includes Labeling.” In the article, Mr. Reilly points out that labeling is a separate issue and will likely not resolve the naming debate and that FDA’s stance on naming will have a global implication, whereas the biosimilar naming approach will have a smaller impact. Read the full article here. |
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New Videos Explain Differences Between Biologics and Biosimilars Amgen Canada has created two new videos explaining what biologics and biosimilars are and how these highly complex medicines differ from each other. The videos show why manufacturing really matters and the importance of patient safety as biosimilars are approved. Read more here. |
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ASBM Advisory Board Chair Quoted in Pharmacy Today The American Pharmacists Association publication, Pharmacy Today, featured an article on biosimilars and quoted Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and ASBM International Advisory Board Chair. In “Pharmacy Today: Pharmacists and health systems prepare to add biosimilars to formularies“ he said: “Even if a drug is considered similar, it should be easily identified. There’s been a longstanding principle in health care that pharmacists have used to avoid look-alike, sound-alike drug names, so the industry’s been asked to change drug names so there aren’t those kinds of mix-ups,” said Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and a member of the international advisory board to the Alliance for Safe Biologic Medicines. “Once a decision is made, it should be very clear what drug the patient’s receiving.” Read the full article here. |
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CE Class on Biosimilars for Pharmacists ASBM’s CE class for pharmacists on the fundamentals of biologics that is being offered through the Long Island School of Pharmacy will be on March 15. The five-hour class “The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know” will explain what biologics and biosimilars are, how they are manufactured and regulatory challenges associated with them. Read more here. |
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Upcoming Conferences:
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